2013 pda fda conference and improving investigations workshop brochure

2013 PDA/FDA Joint Regulatory

Conference, Courses and

Improving Investigations

WorkshopRenaissance Washington Hotel

Washington, D.C.Conference: September 16-18

Exhibition: September 16-17 and 18-19Post-Workshop: September 18-19

Courses: September 19-20

www.pda.org/pdafda2013 | www.pda.org/investigations2013This preliminary agenda is current as of May 22, 2013

Save $150 when you register for the

2013 PDA/FDA Joint Regulatory Conference

and 2013 PDA/FDA Improving Investigations

Workshop

One Week. Two Events. Six Courses.

www.pda.org/pdafda20132

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Program Planning Committee

A Message from the Program Co-Chairs

Co-ChairJoyce Bloomfield Merck Sharpe & Dohme Corporation

Co-ChairSusan SchnieppAllergy Laboratories, Inc.

Douglas Campbell Interpro QRA

David Cummings FDA

Bob Dana PDA

John Finkbohner, PhD MedImmune, Inc.

Richard Friedman FDA

Maria Guazzaroni-Jacobs Pfizer, Inc.

Rhonda Hill FDA

Colleen Hoyt FDA

Mai Huynh FDA

Shane Killian Johnson & Johnson

Renee Kyro AbbVie, Inc.

Elizabeth Leininger, PhD Elizabeth Leininger Consulting

Stanley Liu FDA

Steven Mendivil Amgen, Inc.

Wanda Neal PDA

Kenneth Nolan FDA

Laurie Norwood FDA

Mahesh Ramanadham FDA

Carol Rehkopf FDA

Stephan Roenninger, PhD Amgen (Europe) GmbH

Andrea Viera PDA

Lonnie Warren-Henderson FDA

Dear Conference Attendee,

Mark your calendars now and plan on joining us in Washington, D.C. from Sept. 16–18 for a stimulating 2013 PDA/FDA Joint Regulatory Conference. Hear directly from U.S. FDA experts and decision makers as well as industry professionals who are willing to share their insights and experience. The conference will be held at the Renaissance Washington DC Hotel. This year’s conference theme is Driving Quality and Compliance throughout the Product Life Cycle in a Global Regulatory Environment. Registration will start from 1-6 p.m. on Sunday, Sept. 15, 2013.

The planning committee has developed a program this year to offer attendees new and exciting topics to help make this the “go to” meeting! In joint collaboration with the FDA, the committee has designed the contents of the program to reflect how the quality culture of a company is a foundational cornerstone to attaining successful business goals and objectives. The conference jump-starts with “Plenary Session 1,” offering presentations assessing where the industry stands with respect to quality systems, Quality by Design (QbD) and the drug shortage crisis. The session’s focus is on establishing a common objective for today’s industry, regulatory authorities, health career practitioners and patients: ensuring access to safe, affordable and available medical products. Conference participants will hear from industry and regulatory representatives about some current successes and obstacles for advancing today’s quality systems to meet the needs of today’s and tomorrow’s patients. The conference ends with a panel of FDA experts providing insight into upcoming Center Initiatives. FDA representatives from CBER, CDER, CDRH, CVM and ORA are confirmed to participate in the closing session.

In between the opening and the closing sessions, the conference offers second and third plenary sessions entitled “Quality Culture & Partners” and “Understanding GMPs.” These sessions will discuss how a strong quality culture drives effective quality systems designed to ensure right first time operations to produce high product quality. The third session will mix universal quality principles with practical findings, and emphasize the essential role of robust quality systems in assuring the core business goals of reliable drug quality and availability.

At this year’s meeting, attendees will be offered a choice of three learning tracks:

• “Quality and Compliance”• “Innovation and Technology”• “Product Lifecyle”

These tracks are designed to inform, educate and stimulate the participant’s mind by connecting regulations with practical approaches to current best practices on a variety of topics. The knowledge gained at the conference will be invaluable in helping to establish a holistic approach for managing their company’s product lifecycle with a compliant but practical program.

The “Quality and Compliance” track focuses on the positive impact a functioning and sustainable quality system has on the business needs of a company. There are talks on quality agreements, GMP for APIs, excipients and components, understanding metrics, GDPs, inspections and collaboration, and post-inspectional follow-up. The “Innovations and Technology” track focuses on new and future trends around practical applications of lifecycle concepts, virtual process monitoring concepts, new ideas in outsourcing and novel products, among other topics. Talks on new facility design options, distant process monitoring, outsourcing innovation and novel dosage forms are some of the sessions that are featured as a part of this track. The “Product Lifecycle” track is designed to logically maneuver attendees through the quality and regulatory expectation from the beginning to the end of a product’s lifecycle.

In addition to the track sessions there are seven breakfast sessions with a variety of topics including one on the importance of establishing, maintaining and communicating quality metrics. If all this isn’t enough to compel you to join us in Washington, there are also 12 PDA interest groups meeting at the conference, including the new CMO and Pharmacopeial Interest Groups.

Please join us and bring your colleagues to Washington for another exceptional PDA/FDA Joint Regulatory Conference. We look forward to seeing you.

Best Regards,

Co-Chairs of the 2013 PDA/FDA Joint Regulatory Conference Program Planning Committee

Joyce Bloomfield Merck Sharpe & Dohme Corporation

Susan SchnieppAllergy Laboratories, Inc.

2013 PDA/FDA Joint Regulatory ConferenceDriving Quality and Compliance throughout the Product Life Cycle in a Global Regulatory Environment

September 16-18, 2013 | Renaissance Washington Hotel | Washington, D.C.Exhibition: September 16-17 | Workshop: September 18-19 | Courses: September 19-20

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Sunday, September 15 – Monday, September 16, 2013 AgendaSunday, September 15, 20131:00 p.m. - 6:00 p.m. Registration Open

3:00 p.m. – 6:00 p.m. Speaker Ready Room Open

5:00 p.m. – 6:00 p.m. 2013 PDA/FDA Joint Regulatory Conference Program Planning Committee Meeting

Monday, September 16, 20137:00 a.m. - 5:30 p.m. Registration Open

7:00 a.m. – 5:30 p.m. Speaker Ready Room Open

7:00 a.m. – 8:00 a.m. New Member Breakfast

7:00 a.m. – 8:30 a.m. Continental Breakfast

8:15 a.m. – 8:30 a.m. Welcome, Opening Remarks Anders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc. and Chair, PDA Richard M. Johnson, President & CEO, PDA Joyce Bloomfield, Executive Director, Global GMP Systems & Compliance, Merck Sharp & Dohme Corporation and Co-Chair, 2013 PDA/FDA Joint Regulatory Conference Program Planning Committee

8:30 am. – 10:00 a.m. P1 – Opening Plenary SessionModerator: Susan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc. and Co-Chair, 2013 PDA/FDA Joint Regulatory Conference Program Planning Committee

Providing access to safe, affordable and available drugs is an important objective facing today’s industry, regulatory authorities, health care practitioners and patients. This session will hear from industry and regulatory representatives about some current successes and obstacles for advancing today’s Quality Systems to meet the needs of today’s and tomorrow’s patients.

8:30 a.m. – 9:00 a.m.Regulatory Perspective: Quality Systems, Quality by Design and Drug Shortages – Where are we?Janet Woodcock, MD, Director, CDER, FDA

9:00 a.m. – 9:30 a.m. Industry Perspective: Quality Systems, Quality by Design and Drug Shortages – Where are we? Daniel Kraft, MD, Executive Director, FutureMed

9:30 a.m. – 10:00 a.m. Questions and Answers/Discussion

9:45 a.m. – 7:30 p.m.Exhibit Area Open

10:00 a.m. – 10:45 a.m. Grand Opening of Exhibit Area and Refreshment Break

10:45 a.m. – 12:15 p.m. P2 – Quality Culture & PartnersModerator: Joyce Bloomfield, Executive Director, Global GMP Systems & Compliance, Merck Sharp & Dohme Corporation

A strong Quality Culture drives effective Quality Systems that are designed to ensure right first time operations to produce high product quality. This session will explore how to implement quality culture, how the culture impacts the effectiveness of the Quality System and highlight the significant indicators of a weak quality culture.

10:45 a.m. – 11:10 a.m.How to implement a quality culture across multiple sitesMarty Murawski, Vice President, Quality Management and Continuous Improvement, Hospira, Inc.

11:10 a.m. – 11:35 a.m. How The Quality Culture Impacts the Effectiveness of a Quality System Mary Oates, PhD, Vice President, Global Quality Operations and Environmental, Health and Safety, Pfizer Inc.

11:35 a.m. – 12:00 p.m. Common Findings to Defective Quality Systems David Jaworski, Director, Lachman Consultant Services, Inc.

12:00 a.m. – 12:15 p.m. Questions and Answers/Discussion

12:15 p.m. – 1:15 p.m. Lunch on your own (Exhibit Area Closed)

Janet Woodcock, MD, Director, CDER, FDA

Daniel Kraft, MD, Executive Director,

FutureMed

Opening Plenary SessionKeynote Speakers

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Monday, September 16, 2013 Agenda (continued)1:15 p.m. – 2:45 p.m. Concurrent Sessions

Quality and ComplianceA1 – Quality Agreements

Innovation & TechnologyB1 – New Facility Design Options

Product LifecycleC1 – Beginning of Lifecycle [Development]:

FDA’s Expectations for a Submission

Moderator: Shane Killian, Director, Johnson & Johnson

Moderator: Stephan Roenninger, PhD, Head External Affairs Europe, International Quality, Amgen (Europe) GmbH

Moderator: Laurie Norwood, Deputy Director, DMPQ, CBER, FDA

Session Description: As the pharmaceutical industry increasingly outsources its manufacturing and R&D requirements to third parties or manages a complex supply chain around the world, the Quality Agreement is becoming increasingly important. Failing to clarify goals and expectations, or the responsibilities of the contracting firm and its key vendors or service providers, can leave both partners vulnerable, opening up the possibilities of noncompliance, broken contracts, shortages of key materials, and lost business. This session will highlight FDA expectations along with industry case studies on how to not only establish a Quality Agreement, but engage the companies to follow it.

Session Description: The discussion on the life cycle approach including concepts of QbD, Control Strategy and Continued Manufacturing can only be implemented if the API and drug product are manufactured. The lectures in this session will focus on preventing cross-contamination in facilities. The regulatory expectation on the multi-product facilities will be described. A practical example will demonstrate a decision making process on dedication, implement single-use technology or appropriate cleaning validation.

Session Description: A tremendous amount of work and resources are put into process development for any given product. How do firms capture all the work that goes into developing a product and its control strategies in a marketed application that is easy to review and asses, without having the reviewer go back to the IND? What type of information and format should be included in a marketed application? What is the expectation for information needed in a submission with regard to Quality by design? This session will include expectations for the type of information, expectations for what to submit for a QbD Design Space Approval and control strategies, the easiest format for review and where to submit within your CTD submission for a BLA and an NDA.

1:15 p.m. – 1:45 p.m. Engaging Companies to Establish & Follow Quality AgreementsRebecca Devine, PhD, Biopharmaceutical & Regulatory Consultant

1:45 p.m. – 2:15 p.m. Quality Agreements – Regulatory Perspective Paula Katz, Senior Policy Advisor, CDER, FDA (invited)

2:15 p.m. – 2:45 p.m. Questions and Answers/Discussion

1:15 p.m. – 1:45 p.m. Regulatory Expectations on Managing Multi-product FacilitiesPankaj Amin, Assistant Country Director, CBER, FDA

1:45 p.m. – 2:15 p.m. Decision Model on Running the Facility Scheme: Dedication, Single-use Technology or Appropriate Cleaning Validation Morten Munk, Vice President, Business Development, CMC Biologics A/S


1:15 p.m. – 1:45 p.m. Biotech Products CDER/FDA Speaker (invited)

1:45 p.m. – 2:15 p.m. Small Molecules CDER/FDA Speaker (invited)

2:15 p.m. – 2:45 p.m. Panel Discussion• CBER & CDER Panelists (invited)

2:45 p.m. – 3:15 p.m.Refreshment Break in Exhibit Area




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Monday, September 16, 2013 Agenda (continued)3:15 p.m. – 4:45 p.m.Concurrent Sessions

Quality and ComplianceA2 – GMP for API’s, Excipients

and Components

Innovation & TechnologyB2 – FDASIA

Product LifecycleC2 – Integrated Approach to Product Lifecycle:

Development and Technical Transfer

Moderator: Maria Guazzaroni Jacobs, PhD, Director – Quality and Regulatory Policy, Quality Operations, Pfizer, Inc.

Moderator: David Cummings, Associate Director for Quality, CDER, FDA

Moderator: Renee Kyro, Director, QA Compliance Program Management, Quality Assurance, AbbVie, Inc.

Session Description:Most regulatory agencies around the world accept ICH Q7 as the GMPs to be applied to the manufacture of APIs. But what are the appropriate GMPs to apply to excipients and components? This session will discuss the expectations and regulations in Europe, US, and WHO, and present the view of regulators and industry. The use of risk assessment to the application of appropriate GMPs for these compounds will also be addressed. The session will also present an update on the Q&A being developed by the ICH Implementation Working Group on Q7.

Session Description:On July 9, 2012 President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. This broad legislative package includes a number of initiatives aimed at improving the managed review process, enhancing continuity of drug supply, and bringing greater transparency to agency decision-making processes. In response to this legislation, a structured benefit-risk assessment (SBRA) is being implemented to enhance public transparency to FDA decision-making around patient benefit-risk. FDA and the industry have common interests in this initiative and are working in parallel to achieve the shared goals. Participants will:• Understand how use of risk management

models is expanding outside the compliance arena to the broader clinical regulatory decision-making process

• Gain insights into how the risk assessment generated through this process will aid sponsors in meeting their reporting requirements under ICH E2C (PBRER – Periodic Benefit Risk Evaluation Report) and PSUR – Periodic Safety Update Report) in the future

• Be introduced to the BRAT (Benefit Risk Assessment Tool) framework developed by an industry working group.

Session Description:A key phase in the Product Lifecycle is the technology transfer from development to commercial manufacturing. Integrating the concepts of ICH Q8 into product development along with the risk-based approach concepts of ICH Q9 will assist a company’s realization of a successful technology transfer. Using these integrated concepts with also provide a natural lifecycle progression into the concepts of ICH Q10 and continual improvement within the company’s Quality System. This session will explore industry experience with these concepts and submission expectations of the regulators central to this transition phase of the Product Lifecycle.

3:15 p.m. – 3:45 p.m.GMP for API’sAlicia Mozzachio, Regulatory Director, CDER, FDA (invited)

3:45 p.m. – 4:15 p.m. Embracing Excipient GMPs from a Global Perspective Janeen Skutnik-Wilkinson, Senior Partner, NSF-DBA (invited)


3:15 p.m. – 3:45 p.m.The Impact of FDASIA throughout the Industry Doug Stearn, Deputy Director, Policy and Analysis, CDER, FDA (invited)

3:45 p.m. – 4:15 p.m. Benefit Risk Assessment Tool Speaker (invited)


3:15 p.m. – 3:45 p.m.Industry PerspectivePfizer Speaker (invited)

3:45 p.m. – 4:15 p.m. Regulatory Perspective CDER/FDA Speaker (invited)

4:15 p.m. – 4:45 p.m. Panel Discussion


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Monday, September 16, 2013 Agenda (continued)4:45 p.m. – 6:00 p.m.Concurrent Interest Groups

IG1Supply Chain Management

Leader: Lucy Cabral, Head of Global Supplier Quality Management,Genentech, Inc.

Interest Group Description: The following topics will be discussed in a panel setting with participation from industry leading companies. There will be presentations on the following topics: FDAASIA implementation, EU Falsified Medicines/QP Declaration, Excipients, and Regulatory updates.

IG2 Pharmacopoeial

Leaders: Janeen Skutnik-Wilkinson, Senior Partner, NSF-DBA & Karen Ginsbury, CEO, PCI Pharmaceutical Consulting Israel Ltd.

Interest Group Description: The Interest group will continue to explore current issues and new general chapters in the pharmacopoeias as well as discussing opportunities for international harmonization of monographs. The metal impurities issue continues to generate debate and with implementation date coming closer this will be one of the topics that will be presented. Further updates depending on activity closer to the conference date.

IG3Inspection Trends

Leader: Zena Kaufman, Senior Vice PresidentGlobal Quality, Hospira, Inc.

Interest Group Description: The Interest Group will review recent FDA inspectional observations specific to parenteral manufacturing such as media fills, particulates in parenteral arising from glass defects and Field Alert reporting will be discussed. Recent trends of recalls will also be reviewed. ORA/FDA Speaker (invited)

IG4Filtration

Leader: Russell Madsen, President, The Williamsburg Group, LLC

Interest Group Description: The IG meeting will consist of an audience-directed panel discussion, wherein the attendees are polled for topics of interest, the topics are prioritized, and then discussed with input from an “expert panel” as necessary and appropriate. There will be no formal presentations. The panel will consist of several representatives from different filter companies and possibly the FDA.CDER/FDA Speaker (invited)

IG5Process Validation

Leader: Scott Bozzone, PhD, Senior Manager, Validation, Quality Systems Technical Services (QSTS-V), Pfizer, Inc. & Harold Baseman, CEO, ValSource, LLC

Interest Group Description: We would like to continue having the Process Validation IG meeting at the PDA FDA Regulatory conference in Sept 2013. There remains a strong interest in the subject, since we have met at the last 5 conferences (Annual and PDA-FDA Reg. Conferences) and the PV IG meeting has been very well received in each of these. We have published PDA Tech Report 60 in February of this year. Furthermore, there are also key regulatory activities on-going in process validation such as:

• US FDA Process Validation Guidance (2011) – many still have lots of questions and concerns on it.• EMA is updating its’ Process validation Guidance and issued a draft in March 2012. We

may see it finalized or a EMA response to comments by Sept 2013. • EMA is revising Annex 15 on Validation and Qualification and has issued Concept paper on it. • Other areas of world such as Asean and PIC/S PV Guides are actively pursuing regulatory

impact of the above.

Lastly, there is interest and request to expand or supplement TR 60 (by FDA) and having a meeting in Sept 2013 will help us achieve that goal.

IG6Visual Inspection

Leader:John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

Interest Group Description: The session plans to have one speaker to talk about a Life-Cycle Approach to Visual Inspection. This focuses on using Visual Inspection data to drive continuous process improvement (of both the inspection and manufacturing processes). We would also have our usual regulatory update including current activity at USP to establish a standard for visual inspection of particulates. We will have open discussion of hot topics of interest to those in attendance.

IG7Quality System

Leader:Jennifer Magnani, Associate Director, Global Quality Systems, Genentech, Inc.

Interest Group Description: The PDA Quality System Interest Group is a network of quality professionals. An organization’s Pharmaceutical Quality System (PQS) is the foundation for delivering quality products to patients. Our sessions are open to any industry professional interested in discussing and/or listening to PQS and ICH Q10 related topics. During the 2013 PDA/FDA meeting we will talk about Quality Metrics – what are the important ones that will show you have a good PQS, that your product health exceeds expectations and ones to use to assist in avoidance of drug shortages. FDA and industry experts will share their experiences and we will then kick off our usually lively and informative dialog.Richard Friedman, Associate Director, OMPQ, CDER, FDA (invited)Michelle Noonan-Smith, Quality System Specialist, CDRH, FDA (invited)




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Monday, September 16 – Tuesday, September 17, 2013 Agenda6:00 p.m. – 7:30 p.m. Networking Reception in Exhibit Area (Included with full conference registration)

Tuesday, September 17, 20137:00 a.m. – 5:30 p.m. Registration Open



7:15 a.m. – 8:15 a.m. Concurrent Breakfast Sessions

Breakfast I: Understanding metrics

Breakfast II: Microbiology and Chemistry Lab Findings

Breakfast III: Distant Process Monitoring

Breakfast IV: USP Updates

Moderator: Susan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc.

Moderator: Elizabeth Leininger, PhD, Regulatory Affairs and Quality Consultant, Elizabeth Leininger Consulting

Moderator: John Finkbohner, PhD, Senior Director, Regulatory Affairs, MedImmune, Inc.

Moderator: Jon Clark, Associate Director for Program Policy, OPS, CDER, FDA

Session Description:Metrics are an important element in driving continuous quality improvement in today’s manufacturing environment. This breakfast session will educate the audience on the fundamentals of chosing meaningful quality metrics and how to interpret and make the necessary operational changes to improve product quality based on the data collection.

Session Description:While much focus has been on the manufacturing process and product supply in recent years, the laboratory is also a critical part of a pharmaceutical operation. This session will discuss the importance of maintaining a reliable laboratory, and will include some FDA inspection findings in microbiology and chemistry laboratories.

Session Description:Recent advances in information technology now afford manufacturing managers access to timely production data. Distant process monitoring can now give distant management team’s access to production information which can impact the resource cost associated with in-process monitoring. While the concept of distant monitoring is not a new concept to the manufacturing industry such as producers of medical gases, there are a number of challenges and opportunities when applied to various medical products manufacturing sectors.

These topics for consideration include:

• Production of carcinogenic drugs,

• Selection of process parameters for monitoring,

• In-process detection of bioburden for aseptic processes,

• Automated analytical methods,

• Information security,• Adequacy of regulations, and • Generation of manufacturing

and validation records.

Session Description:Collaboration between the USP and FDA is extremely important in order to enhance and protect the quality of pharmaceutical products now and in the future. This session will focus on these collaborative efforts for current initiatives both at USP and FDA (e.g., monograph and general chapter modernization, elemental impurities). The session will address the opportunities that these collaborations present for securing the quality of the American drug supply.


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Tuesday, September 17, 2013 Agenda (continued)

Breakfast I: Understanding metrics

(continued)

Breakfast II: Microbiology and Chemistry Lab Findings

(continued)

Breakfast III: Distant Process Monitoring

(continued)

Breakfast IV: USP Updates (continued)

This session will touch upon the experience issues of distant process learning. Participants will leave with an understanding of the possibilities and challenges in moving toward a more innovative approach to manufacturing.

7:15 a.m. – 7:45 a.m.Metrics that Drive Good QualitySteven Mendivil, Executive Director, International Quality External Affairs, Amgen, Inc.

7:15 a.m. – 7:35 a.m.Regulatory Microbiology for Sterile Compounded Drugs: Samples to SuspectsDennis Guilfoyle, PhD, Pharmaceutical Microbiologist, ORA, FDA

7:35 a.m. – 7:55 a.m. Chemistry Lab Controls / Audit Findings Michele Obert, Investigator, ORA, FDA (invited)

7:55 a.m. – 8:15 a.m. Questions and Answers/ Discussion

7:15 a.m. – 8:15 a.m.Karen McCullough, Prinicpal Consultant, MMI Associates

Questions and Answers/ Discussion

7:15 a.m. – 8:15 a.m.Panel Discussion• Ali Al Hakim, PhD, Branch

Chief, ONDQA, CDER, FDA (invited)

• Robert Iser, Director, Division of Chemistry IV, CDER, FDA (invited)

• Paul Seo, PhD, Director, Compendial Operations, Standards and Technology, CDER, FDA (invited)

• USP Speaker (invited)

8:30 a.m. – 10:00 a.m.P3 – Understanding Good Manufacturing Practices Moderator: Richard Friedman, Associate Director, OMPQ, CDER, FDA

Session Description:This session will discuss how safety and efficacy is assured by routine adherence to the quality assurance and manufacturing control practices embodied in the GMPs. Presenters from FDA and industry will discuss how GMPs have evolved, and why responsive systems and good governance are so important to assure reliable pharmaceutical operations and safe products. Presenters will also discuss quality assurance lapses that led to major defects and manufacturing problems. The session will mix universal quality assurance principles with practical findings, and emphasize the essential role of robust quality systems in assuring the core business goals of reliable drug quality and availability.

8:30 a.m. – 8:55 a.m.Evolution of GMP Provisions in the Act: Important Lessons Learned from HistoryCathy Burgess, Partner, Alston and Bird

8:55 a.m. – 9:20 a.m. Evaluating GMP Significance and Assuring Quality Mary Anne Malarkey, Director, Office of Compliance, CDER, FDA

9:20 a.m. – 9:45 a.m. Quality Matters: How the Preventive Systems of GMPs Meet Core Business Objectives Juan Andres, Head, Group Quality, Novartis (invited)

9:45 a.m. – 10:15 a.m. Panel Discussion:• John D. Ayres, MD, Senior Director, Product Safety Assessments, Global Patient Safety, Eli Lilly & Company• Cathy Burgess, Partner, Alston and Bird• Mary Anne Malarkey, Director, Office of Compliance, CDER, FDA• Juan Andres, Head, Group Quality, Novartis (invited)




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Tuesday, September 17, 2013 Agenda (continued)9:45 a.m. – 3:30 p.m.Exhibit Area Open

10:00 a.m. – 10:45 a.m. Refreshment Break in Exhibit Area and Passport Raffle Drawings

10:45 a.m. – 12:15 p.m. Concurrent Sessions

Quality and ComplianceA3 – Good Distribution Practices

Innovation & TechnologyB3 – Outsourcing Innovation

Product LifecycleC3 – Managing Supply Crisis /

Drug Shortages

Moderator: Steven Mendivil, Executive Director, International Quality External Affairs, Amgen, Inc.

Moderator: Susan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc.

Moderator: Colleen Hoyt, Supervisor, Team Biologics, ORA, FDA

Session Description: EU has recently published final Good Distribution Guidance that contains new requirements for distribution within the Supply Chain. This session will highlight important new requirements with EU GDPs and look at other global distribution requirements and the mechanisms firms are putting into place to meet these new challenges.

Session Description:Outsourcing various functions is an increasing trend in today’s industry. In some scenarios, everything from clinical trials to quality oversight of the manufacturing process is delegated to a service provider. This session will explore some of the novel approaches being taken by outsourcing companies and their contractual partners on how they communicate and improve quality when multiple parties, opinions and approaches are involved.

Session Description:Shortages of critically important medications adversely affect patient populations. What is your company doing to mitigate and prevent these shortages from occurring and ensure a dependable supply of high quality drug products to patients? This session will present strategies for mitigating risk to prevent supply interruptions and the consequences of not making a product.

10:45 a.m. – 11:15 a.m.Global Distribution ComplexityDavid Ulrich, Director QA, Distribution Global Pharmaceutical Operations, AbbVie, Inc. (invited)

11:15 a.m. – 11:45 a.m. EU GDPs Tony Orme, Senior GDP Inspector, MHRA (invited)


10:45 a.m. – 11:15 a.m.FDA Expectations for Outsourcing ActivitiesLaurie Norwood, Deputy Director, DMPQ, CBER, FDA

11:15 a.m. – 11:45 a.m. Outsourcing Innovations from a CMO’s Perspective EJ Brandreth, VP, Quality and Regulatory Affairs, Althea Technologies


1:15 p.m. – 1:45 p.m.Economic and Technological Drivers of Generic Drug ShortagesMarta Wosinska, Director, Economics Staff, CDER, FDA

1:45 p.m. – 2:15 p.m. Industry Challenges with Drug Shortages John O’Sullivan, Vice President, Quality Strategy & IAQC, Pfizer Inc.


12:15 p.m. – 1:15 p.m. Lunch on your own (Exhibit Area Closed)

“I don’t know of any other event where there are so many representatives of the regulatory bodies, sharing their insight and plans

for the future, in a positive teambuilding environment.”EJ Brandreth, Althea Technologies, Inc.


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Tuesday, September 17, 2013 Agenda (continued)1:15 p.m. – 2:45 p.m. Concurrent Sessions

Quality and ComplianceA4 – International Trends: Inspections

and Collaboration

Innovation & TechnologyB4 – Combination Products and

Companion Diagnostics

Product LifecycleC4 – Lifecycle Towards Commercial

Manufacturing

Moderator: Richard Friedman, Associate Director, OMPQ, CDER, FDA

Moderator: Stanley Liu, Consumer Safety Officer, CDRH, FDA

Moderator: Maik Jornitz, Chief Operating Officer, G-CON, LLC

Session Description:This session will cover the latest news and trends in the areas of international regulatory collaboration and compliance. Major inspection findings, compliance actions, and joint regulatory efforts to converge inspection practices will be addressed by the presenters.

Session Description: Dosage forms for drugs, biologics, and combination products are multi-varied and continuously evolving. This session will educate attendees on the current status of Companion Diagnostics and Combination Products.

Session Description:The management of the lifecycle of a product towards the commercial phase is multifaceted and requires appropriate attention. The establishment of the quality systems and robust technology transfer are essential parts to of activities towards commercialization. In addition, economical and risk based decisions need to be made to be prepared for a successful launch meeting the demands, but also to minimize financial burdens, if the product does not achieve its promised efficacies or safety. The speakers will address the different activities within the lifecycle management towards commercialization and thorough preparations necessary.

1:15 p.m. – 1:45 p.m.InspectionsCarmelo Rosa, Director, Division of International Quality, OMPT, CDER, FDA (invited)

1:45 p.m. – 2:15 p.m Collaboration Raphael Brykman, Acting Team Leader, Office of Strategy, Partnerships and Analytics, OC, FDA (invited)


1:15 p.m. – 1:40 p.m.Combination Products Regulation and Guidance UpdatePatricia Love, Deputy Director Office of Combination Products, OC, FDA

1:40 p.m. – 2:05 p.m. CDRH Compliance Perspective on Combination Product Manufacturing and Controls Isabel Tejero, Consumer Safety Officer, CDRH, FDA

2:05 p.m. – 2:30 p.m. Companion Diagnostics Elizabeth Mansfield, Director, Personalized Medicine Staff, Office of In-vitro Diagnostics, CDRH, FDA (invited)


10:45 a.m. – 11:15 a.m.Industry Perspective: Building up of a Quality System and Tech Transfer EJ Brandreth, VP, Quality and Regulatory Affairs, Althea Technologies

11:15 a.m. – 11:45 a.m. Regulatory Perspective: Building up of a Quality System and Tech Transfer FDA Speaker (invited)


2:45 p.m. – 3:15 p.m. Refreshment Break in Exhibit Area and Passport Raffle Drawings

3:15 p.m. – 4:45 p.m. Concurrent Sessions

Quality and ComplianceA5 – Post Inspectional Follow-up

Innovation & TechnologyB5 – Submission Review

Product LifecycleC5 – Continuous Improvement

Moderator: Douglas Campbell, Senior Consultant, Interpro QRA

Moderator: Mai Huynh, Supervisory Team Leader, CVM, FDA

Moderator: Mahesh Ramanadham, Regulatory Compliance Officer, OMPQ, CDER, FDA

Session Description:Compliance is a common goal within the pharmaceutical industry. In the reality of the global regulatory environment, the FDA is actively conducting inspections and

Session Description:The U.S. FDA has developed a question-based review (QbR) for quality evaluation of human Abbreviated New Drug Application (ANDA) and veterinary drug applications

Session Description:It’s often seen that commercial manufacturing processes are ‘locked in’ after application approval and initial process qualification. There is often a minimal




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Quality and ComplianceA5 – Post Inspectional Follow-up

(continued)

Innovation & TechnologyB5 – Submission Review

(continued)

Product LifecycleC5 – Continuous Improvement

(continued)

enforcement actions. Most will agree that there is a stigma attached to documented non-compliance, and this leads to anxiety, lack of understanding, and misconceptions about the process. This session will provide insight related to the expectations and responsibilities of all parties, while striving to initiate discussion related to transparency and communication with the FDA.

(INAD, NADA, ANADA). This new QbR system incorporates quality by design and implements risk-based assessment. It recommends that CMC applications include the Quality Overall Summary (QOS) that addresses all the QbR questions. The main benefits of this QbR system are to 1) assure product quality through design and performance-based specifications, 2) facilitate continuous improvement and reduce CMC supplements through risk assessment, 3) enhance the quality of reviews through standardized review questions, and 4) reduce CMC review time when applicants submit a QOS that addresses the QbR questions.

incentive to change and improve the manufacturing process to minimize variability and improve performance due to perceived regulatory hurdles. This session reiterates the essentiality of continual improvement of the manufacturing process, its regulatory foundation, and its positive impact to the industry and patient. It will also highlight the need to utilize cross functional quality signals to identify process failure, optimize process capability, and improve product quality for the patient.

3:15 p.m. – 3:45 p.m. Post-Inspection Expectations and Procedures: For International Drug Inspections Carmelo Rosa, Director, Division of International Quality, OMPT, CDER, FDA (invited)

3:45 p.m. – 4:15 p.m. Post-Inspection Expectations and Procedures: For Domestic Drug Inspections Nancy Rolli, Director, Compliance Branch, ORA, FDA (invited)

4:15 p.m – 4:45 p.m. Questions and Answers/Discussion

3:15 p.m. – 3:40 p.m. Question Based Review Lawrence Yu, PhD, Deputy Director, Office of Pharmaceutical Science, CDER, FDA

3:40 p.m. – 3:55 p.m. Question Based Review – Sterile Products Kristen Anderson, PhD, Senior Microbiologist, Division of Manufacturing Technologies, CVM, FDA

3:55 p.m. – 4:20 p.m. Question Based Review – Industry’s perspective Molly Rapp, Vice President, Regulatory Affairs Generics, Fresenius Kabi USA


3:15 p.m. – 3:45 p.m. Regulatory Perspective on Post- Approval Manufacturing Optimization and Continuous Process Verification Grace McNally, Senior Policy Advisor, CDER, FDA (invited)

3:45 p.m. – 4:15 p.m. Continuous Improvement in the Product Quality Lifecycle John D. Ayres, MD, Senior Director, Product Safety Assessments, Global Patient Safety, Eli Lilly & Company (invited)


4:45 p.m. – 6:00 p.m.Concurrent Interest Groups

IG8 Blow Fill Seal

Leaders: Chuck Reed, Director, Sales & Marketing, Weiler Engineering, Inc.

Interest Group Description: This IG session will discuss the following topics:

• Update on BFS Technical Report• Use of regrind resin – pros, cons and regulatory perspective• Resin updates – this is a tired topic, but still relevant due to more industry changes• Interventions – what is typical/allowable?• Viable sampling procedures – where and how often? • Alert and action limits for particle counts

IG9 Packaging Science

Leader:Edward Smith, PhD, Principal, Packaging Science Resources, LLC

Interest Group Description: The packaging science interest group session will have 3 presentations on the following topics:

Overview of Recently Revised PDA TR 43 – Glass Nonconformities – The original TR 43 was issued in 2007 and covered only tubular and molded vials. The revised version also includes a lexicon and discussion of the nonconformities of cartridges, ampoules, and syringes. This TR has become the leading reference for the quality of glass packaging components. The presentation will be made by a member of the PDA Task Force that authored the TR.


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IG9 Packaging Science(continued)

Leader:Edward Smith, PhD, Principal, Packaging Science Resources, LLC

Extractables & Leachables (E&L) from Packaging & Processing Components – Regulatory expectations regarding E&L from both packaging and processing components have continued to evolve rapidly since the publication of the FDA’s Packaging Guidance in 1999. The PQRI has published best practices for the management of E&L for inhalation products (2006) and this has been used as the basis for submissions to FDA ever since. A PQRI TF is now developing procedures & best practices for a larger and more diverse segment of pharmaceutical products – ophthalmics and injectables. A member of the TF will discuss the status of this work and compare the practices developed to date with those for inhalation products.

New and Developing USP Chapters that Affect Packaging – Two new USP chapters on Elemental Impurities, 232 & 233, became official Feb. 1, 2013. These chapters affect not only drug products but also the packaging components used to contain and deliver these products. The USP has also discussed the development of chapters on both Extractables and on Leachables. A member of USP will provide an update on chapters that impact packaging.

IG10 GMP Links to Pharmacovigilance

Leader: John D. Ayres, MD, Senior Director, Product Safety Assessments, Global Patient Safety, Eli Lilly & Company

Interest Group Description: The interest group was established in 2012. We have had the opportunity to meet for kick-off sessions in both the US and Europe. At the PDA/FDA Joint Regulatory Conference we will plan to identify topics of relevance that land squarely in this intersection. When a deviation or consumer complaint is identified, the first question for consideration is: What are the implications to patient safety? A model to engage in this assessment will be presented. We will also look at issues such as 3 Day Field Alerts, Drug Shortage, and developing product complaint and adverse event surveillance protocols to monitor change controls, stability findings, etc.

IG11 Clinical Trials

Leader: Galen Shi, PhD, Director, Global Clinical Trial Material Manufacturing, Eli Lilly & Company

Interest Group Description: Sourcing Strategy and Vendor/Client Management in Clinical Trial Materials Supply Chain

The manufacture, packaging and distribution of clinical trial materials for biotech companies and big Pharmas can occur in both in-house manufacturing or outsourcing to CMO’s. The effective management of relationship with internal and external partners is of utmost importance to ensure on time delivery of quality materials for clinical trials. This meeting is targeted to discuss various models and strategies for innovation companies to engage manufacturing/packaging/distribution partners. Representatives from both industries (innovation research and contract CMO) are invited to discuss their experiences in working together to ensure the smooth operations of CT material supply chain.

IG12 Pre-filled Syringe

Leader: Thomas Schoenknecht, PhD, Director Global Key Account Management, SCHOTT AG

Interest Group Description: Over the last six years numerous cases have been reported about imperfect alignment of drug delivery container characteristics and injection devices capabilities & requirements.

Some of them have induced market recalls because of breakage or insufficient siliconization and substantial work was done to better align the design space for the combination of container and device.

The session should give insights to the extensive work done at pharmaceutical industry and reflect the changing regulatory requirements on the basis of lessons learned reported by short presentations from industry experts and knowledge exchange with the group in a panel discussion.

IG13 Facilities & Engineering

Leader: Christopher Smalley, PhD, Director, BioSterile Validation, Merck and Company Inc.

Interest Group Description: This interest group will focus on discussing the topic of “Controlling Contamination.”

• Facility Design – is your design robust enough to not only prevent contamination, but withstand cleaning processes?

• Facility Cleaning- balancing short-term cleaning needs with long-term objectives to pre-serve and maintain the facility.




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Tuesday, September 17 – Wednesday, September 18, 2013 Agenda

IG14Quality Risk Management

Leaders: Jeffrey Hartman, Director, Validation Quality Assurance, Merck Sharp & Dohme CorporationMichael Long, PhD, Director & Principal Consultant, ValSource, LLC

Interest Group Description: This session will focus on the important topic of Drug Shortages and How the industry can apply risk management tools and techniques to identify and reduce risks along the supply chain. Two presentations, along with group discussions, will be provided. The presentations will include regulatory and industry views on how to tackle the issue as well as a framework for the Use of QRM in managing the risks Presented by PDA’s QRM/Drug Shortage working group.

Jeffrey Baker, Deputy Director, CDER, FDA (invited)

6:30 p.m. – 9:30 p.m. Gala Reception: All That Jazz Offsite Venue

Wednesday, September 18, 20137:00 a.m. – 12:00 p.m. Registration Open



7:30 a.m. – 8:30 a.m.Concurrent Breakfast Sessions

Breakfast V: CDER Reorganization Breakfast VI: Technical Report UpdatesBreakfast VII: PDA Comments to

Regulatory Documents

Moderator: David Cummings, Associate Director for Quality, CDER, FDA

Moderator: Richard Levy, PhD, Senior Vice President, Scientific and Regulatory Affairs, PDA

Moderator: Steven Mendivil, Executive Director, International Quality External Affairs, Amgen, Inc.

Session Description:A discussion of FDA’s proposed plans for an Office of Pharmaceutical Quality (OPQ) including the rationale, concepts of operations and emerging areas of focus including quality metrics.

Session Description: Our industry is experiencing a transition to globalization which encompasses regulations and compliance activities. Over a 5-10 year horizon economic forces will likely drive compliance, regulations and guidance to a significantly more harmonized status. Mutual recognition agreements, and the entry of FDA into PIC/S are evidence of this change. Despite this trajectory, regional, national and state regulations and guidance remain disparate, and opportunity exists for facilitating the transition to more convergent and harmonized guidance on sterile manufacture (terminal sterilization and aseptic manufacture). PDA task force leaders will report on their efforts to compare existing guidance in this important area.

Session Description:A review of the past years important new draft and final global regulatory documents that RAQAB was aware of. Also highlights key PDA comments over the past year.

7:30 a.m. – 8:00 a.m.FDA’s Evolving Approach to Product QualityRussell Wesdyk, OPS Scientific Coordinator, CDER, FDA (invited)

8:00 a.m. – 8:30 a.m. Questions and Answers/Discussion

7:30 a.m. – 8:00 a.m.Gap Analysis Between US and EU Sterile Manufacture Guidance and RegulationsJette Christensen, Aseptic Scientific Director, Novo Nordisk A/S

8:00 a.m. – 8:30 a.m.Questions and Answers/Discussion

7:30 a.m. – 8:00 a.m.Susan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc.

8:00 a.m. – 8:30 a.m.Questions and Answers/Discussion

“As always, the conference was a unique opportunity to meet peers and regulators and

have some good dialogues on Quality, the Industry, and Regulatory challenges.”

Bob Darius, GSK


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Wednesday, September 18, 2013 Agenda Continuing Education CreditsThe PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign

in at the beginning of the program, submit the provided evaluation forms and submit the CPE credit request form to the registration desk following full attendance of this event. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

2013 PDA/FDA Joint Regulatory MeetingACPE 0116-9999-13-088-L04-P | 1.542 CEUsType of Activity: Knowledge

For course CEUs and ACPE information for individual courses, see pages 15-16.

learning Objectives: • Describe industry measures and regulatory expectation on the drug

shortage issue currently facing patients the industry• Examine approaches to managing supply chain concerns

interruptions or crises related to their products• Facilitate post inspectional follow-ups including responding to 483’s or

regulatory expectations and meeting requests• Explain the importance of a robust quality agreement and supplier

oversight• Define the issues and challenges of outsourcing activities• Explain FDA’s expectation for submissions• Interpret expectations on cGMPs for Active Pharmaceutical

Ingredients• Describe the current thinking and regulatory framework regarding

Good Distribution Practices (GDP)• Identify key performance indicators for measuring quality with in

their company

Who Should Attend:Departments Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales

Job Functions Supply Chain | Clinical Supply Material Preparation | Executive Management

8:45 a.m. – 9:10 a.m.P4 – A Patient’s Perspective Moderator: Robert Dana, Senior Vice President, Education, PDA

Session Description:Sometimes as we do our daily jobs it is easy to forget the ultimate goal of our companies which is to make safe and effective pharmaceutical products for patients. Patients who have benefited from our efforts will help us focus on our mission by expressing how our products have helped to save their lives.

Rick Roberts, Adjunct Professor, University of San Francisco

9:15 a.m. – 10:45 a.m.P5 – Compliance UpdateModerator: John Finkbohner, PhD, Senior Director, Regulatory Affairs, MedImmune, Inc.

Session Description: This session will feature the Compliance Directors from the FDA’s Centers and Office of Regulatory Affairs who will provide a short update on current hot topics in the compliance area. Significant FDA483 observations and other regulatory actions will be covered. Ample time will be provided for the Compliance Directors to participate in a Q and A session, taking questions from the floor. Don’t miss this opportunity to hear the latest in the compliance area; come prepared with your questions.

Panel Participants:• CBER: Mary Anne Malarkey, Director, Office of Compliance, FDA (invited)• CDER: Douglas Stearn, Deputy Director for Policy and Analysis,

FDA (invited)• CDRH: Steven Silverman, Director, Office of Compliance, FDA• CVM: Martine Hartogensis, Deputy Director, FDA• ORA: Armando Zamora, Acting Director, OE, FDA

10:45 a.m. – 11:00 a.m.Refreshment Break

11:00 a.m. – 12:30 p.m. P6 – Center InitiativesModerator: Steven Mendivil, Executive Director, International Quality External Affairs, Amgen, Inc.

Session Description: In this session we will hear directly from some of the agency’s leaders with regard to their Center’s current and future initiatives.

Panel Participants:CBER: Karen Midthun, MD, Director, FDA (invited)CDER: Representative (invited)CVM: Bernadette Dunham, DVM, PhD, Director, FDA (invited)ORA: Steve Solomon, Deputy Associate Commissioner, FDACDRH: Kimberly Trautman, Associate Director for International

Affairs, FDA (invited)

12:30 p.m. Closing Remarks and AdjournmentSusan Schniepp, Vice President – Quality and Regulatory Affairs, Allergy Laboratories, Inc.




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• Apply the principles learned to conduct risk management activities for a variety of product-related and operational decisions in your job

InstructorsJeffrey Hartman, Validation Manager, Merck Emma Ramnarine, Head, Global Quality Risk Management, F. Hoffman-La Roche Ltd.

gMPs for Manufacturers of Sterile and/or Biotechnology Products September 19, 2013 | 8:30 a.m.– 4:00 p.m.PDA #242 | ACPE #0116-0000-13-242-L04-P | 0.6 CEUs Type of Activity: Knowledge

This course discusses the practical implementation of GMPs in facility and equipment design, in process design and operations. Participants will leave with an understanding of the microbiology of bacteria and their lethality, the regulatory expectations for equipment and utility qualification and sterile process validation in order to assure that the products manufactured are proof-positive sterile.

Who Should AttendThis course is designed as an intermediate level course for supervisors and managers needing to understand the theoretical and practical background for the successful manufacture of sterile pharmaceutical and biotechnology products. Production, Engineering, Regulatory and especially Quality Assurance staff will benefit from this course. The examples of industry successes and failures will provide practical approaches of what attendees should and should not do in their facilities to manufacture sterile products.

learning ObjectivesUpon completion of this course, you will be able to:

• Explain how bacteria and viruses live and die• Describe the unique concerns for

biotechnology facility design• Summarize requirements, installation issues,

and qualification of HVAC Systems, Water Systems, and Compressed Air and Nitrogen Systems

• Discuss terminal sterilization technologies, such as designing sterilization cycles, theoretical and practical considerations in sterilization processes, depyrogenation

PDA Training and Research Institute (PDA TRI) Courses – September 19-20, 2013

Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology Manufacturing Operations September 19, 2013 | 8:30 a.m. – 4:00 p.m.PDA #359 | ACPE #0116-0000-13-359-L04-P | 0.6 CEUs Type of Activity: Knowledge

This course will provide detailed guidance for application and implementation of quality risk management principles throughout the product lifecycle, with emphasis on quality risk management application during commercial manufacturing, and integrating quality risk management into the Pharmaceutical Quality System. The course will build on the content and principles of ICH Q9, Quality Risk Management. The application of quality risk management will be discussed from a life-cycle approach, from pharmaceutical development to technology transfer, commercial manufacturing, product discontinuation, and will include materials management and contract services. Case study examples of quality risk management application will be given for different types of manufacturing operations such as biotech API manufacturing, drug product manufacturing, packaging and labeling.

Who Should AttendManagers and supervisors in manufacturing, technology transfer, quality assurance and regulatory affairs will benefit from this course.

PrerequisitesA basic understanding of risk management principles will be helpful to participants in this course.


• Describe when, where, and how to apply quality risk management throughout the product lifecycle with emphasis on commercial manufacturing

• Plan quality risk management activities• Execute risk assessments and develop an

overall strategy for the use of different risk assessment tools

• Establish a quality risk management policy and implement the essential elements for risk management in your organization

In conjunction with the 2013 PDA/FDA Joint Regulatory Conference, the PDA Training and Research Institute (PDA TRI) is offering six courses to complement your learning at the conference.

All courses will be held at the Renaissance Washington DC Hotel.

issues, and the essential differences between designing and operating a facility for terminal sterilization and for aseptic processes.

• Identify the challenges of aseptic processing in the manufacture of sterile and/or biotechnology products

InstructorMichael Anisfeld, President, Globepharm Consulting, Inc.

CMC Regulatory Requirements in Drug ApplicationsSeptember 19, 2013 | 8:30 a.m. – 4:00 p.m. PDA #253 | ACPE #0116-0000-13-253-L04-P | 0.6 CEUs Type of Activity: Knowledge

This course provides a basic understanding of CMC requirements in drug applications. It will help prepare those in regulatory affairs to better address the key points required to be included in the CMC sections of drug product applications. Topics to be covered include CMC in Investigational New Drug Applications, New Drug Applications, Abbreviated New Drug Applications, drug master files, and post-approval changes supplements. Manufacturing GMP compliance and an introduction to biological license applications will also be briefly discussed.

Who Should Attend:Personnel in CMC Regulatory Affairs, QA and QC, and chemical research and development will benefit from this course.

learning Objectives:Upon completion of this course, you will be able to:• Identify different types of drug

applications/supplements• Explain CMC requirements for different

types of drug applications or supplements• Discuss key points in preparation of

CMC sections for different types of drug applications

InstructorZi-Qiang Gu, PhD, Pharmaceutical Consultant (Former FDA CMC reviewer and GMP Compliance Officer)


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PDA Training and Research Institute (PDA TRI) Courses – September 19-20, 2013

Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Packaging and labeling of Drug Products September 20, 2013 | 8:30 a.m. – 4:00 p.m. PDA #447 | ACPE #0116-0000-13-447-L04-P | 0.6 CEUs Type of Activity: Application

This lecture course will utilize the methodology of PDA Technical Report No. 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations, to identify, assess, manage and use risk to make informed decisions in packaging and labeling operations. In addition, this course will provide participants with a systematic approach to recognizing potential risks and analyzing them by exploring case studies aimed at highlighting the different applications of quality risk management throughout the pharmaceutical and biotechnology manufacturing operations in packaging and labeling. The course will also include background information in quality risk management, regulatory expectations, and unique aspects of risk management, organizational culture, risk assessment methods and examples and practical exercises to assess risk.

Who Should AttendThis course is designed for all personnel involved in the implementation of a quality risk management program. Specifically, this course is targeted for personnel in disciplines such as quality assurance, quality control, engineering, validation, production and technical services who are or will be participating in risk assessment sessions. The course is also targeted towards supervisors, managers and directors of the above disciplines who often make risk based decisions based on the outcome of the risk assessments.

learning ObjectivesUpon completion of this courses, you will be able to:

• Describe the concepts of risk management: risk identification, risk analysis, risk evaluation, risk reduction, risk acceptance and risk review

• Identify common risks in packaging and labeling operations

• Discuss examples of controls implemented to address risks in packaging and labeling operations

• Explain risk based compliance, risk based decisions and how to focus efforts on the greatest risks to patient safety and product quality

• Apply principles of quality risk management to other production areas

Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances September 20, 2013 | 8:30 a.m. – 4:00 p.m. PDA #305 | ACPE #0116-0000-13-305-L04-P | 0.6 CEUs Type of Activity: Application

This course will consist of lectures and workshops designed to help participants identify risks in bioprocesses. The workshop portions of the course will be conducted in small groups working on open ended scenarios to identify risk groups and judge their magnitudes and potential impacts.

Who Should AttendThis course should be taken by pharmaceutical professionals engaged in developing, scaling up and manufacturing with biotechnology based processes. The course would be valuable to anyone involved in chemistry, manufacturing and controls as they apply to bioprocesses.

• Manufacturing supervisors, managers, directors

• Process development biochemists, microbiologists, cell biologists and molecular biologists

• Process engineers• Quality assurance professionals• Regulatory CMC supervisors, managers and

directors


• Identify risks in bioprocess manufacturing• Classify risks and rate their potential for

impact to patients and other stake holders• Explain how to reduce risk through process

understanding• Identify risks that are consequences of raw

material choices, containers, storage and shipping

• Prioritize risk reduction• Formulate a plan for risk reduction for a

bioprocess• Update the plan through the product lifecycle

InstructorScott Rudge, COO, RMC Pharmaceutical Solutions, Inc.

InstructorGhada Haddad, Associate Director, Engineering, Biosterile Validation, Merck & Co, Inc.

Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Manufacturing of Pharmaceutical Drug Products September 20, 2013 | 8:30 a.m. – 4:00 p.m. PDA #231 | ACPE #0116-0000-13-231-L04-P | 0.6 CEUs Type of Activity: Application

This interactive course will provide attendees with an overview of how to implement quality risk management (QRM) for pharmaceutical and biopharmaceutical manufacturing. Specific case studies from drug manufacturing will be used as part of this training course. Practical examples will be provided on the use and application of quality risk management, including the benefits and challenges, in order to improve product quality and compliance.

Who Should AttendIndividual contributors and managers in QA, Manufacturing, Engineering, Validation, Technical Support, and R&D will benefit from this course.

PrerequisitesAttendees should have knowledge of basic pharmaceutical or biopharmaceutical manufacturing, and some exposure to quality risk management tools.


• Identify various QRM tools that can be used and select the most appropriate ones

• Discuss basic principles and application of QRM with peers, using standard QRM terminology

• Describe the difference between risk management and risk assessment

• Explain what a risk register is and what should be in it

• Identify the different types of controls that can be put in place to reduce risk

• Lead a cross-functional team to perform risk assessments

• Discuss the challenges in implementing QRM into existing quality systems, including maintaining risk assessments as living documents

InstructorWilliam Harclerode, Associate Director, Forest Labs


general InformationThree Ways to Register

1. Click www.pda.org/pdafda2013 or www.pda.org/investigations20132. Fax +1 (301) 986-10933. Mail PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 150 Bethesda, MD 20814 USA

Venue

Renaissance Washington DC Hotel 999 9th Street NW, Washington, DC 20001 Phone: +1 (202) 898-9000 Website: https://www.marriott.comRate: Single: $299.00, plus applicable state and local taxes. Cut Off Date: Wednesday, August 21, 2013 (Rooms must be secured by this date in order to receive the PDA rate). Housing at this hotel will be in high demand, so we strongly recommend making your reservations early.

Conference and Workshop Registration Hours

Monday, September 16: 7:00 a.m. – 5:30 p.m.Tuesday, September 17: 7:00 a.m. – 5:30 p.m.Wednesday, September 18: 7:00 a.m. – 5:00 p.m.Thursday, September 19: 7:00 a.m. – 3:15 p.m.

TRI Course Registration Hours

Thursday, September 19: 7:30 a.m. – 4:00 p.m. Friday, September 20: 7:30 a.m. – 4:00 p.m.

Dress/Attire

Business casual attire is recommended for the 2013 PDA/FDA Joint Regulatory Conference and the 2013 PDA/FDA Improving Investigations Workshop. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

Special Requirements

If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to [email protected].

group Registration

Register 4 people from the same organization and site location as a group (at the same time) for the conference and receive the 5th registration free. Other discounts cannot be applied.

Contact Information

Conference Inquiries:Wanda Neal, CMP, Senior Vice President, Programs and Registration Services Tel: +1 (301) 656-5900 ext. 111 E-mail: [email protected]

Registration Inquiries: Patresa Day, Manager, Registration and Customer Service Tel: +1 (301) 656-5900 ext. 115 E-mail: [email protected]

Workshop Inquiries: Jason Brown, Senior Manager, Programs and Meetings Tel: +1 (301) 656-5900 ext. 131 E-mail: [email protected]

PDA TRI Course Inquiries: Stephanie Ko, Senior Manager, Lecture Education Tel: +1 (301) 656-5900 ext. 151 E-mail: [email protected]

Exhibition/Sponsorship Inquiries: David Hall, Vice President, Sales Tel: +1 (301) 656-5900 ext. 160 | Cell: +1 (240) 688-4405 E-mail: [email protected]

PDA Conference Recordings

Interactive Online LearningIf you missed any of the

following PDA events, you can still access them and more via PDA’s

Online Learning Library.

• 2012 PDA/FDA Joint Regulatory Conference

• Responsibilities of Executive Management (Operations and Quality) – Implementing the Principles of ICH Q10: 2012 PDA/FDA Pharmaceutical Quality Systems Workshop

• 2012 Universe of Pre-filled Syringes & Injection Devices

• PDA 7th Annual Global Conference on Pharmaceutical Microbiology

• 2012 PDA/FDA Pharmaceutical Supply Chain Conference

• 2012 Pharmaceutical Cold Chain & Good Distribution Practice Conference

• 2012 PDA/FDA Vaccines Conference

• 2013 PDA Annual Meeting

Visit www.pda.org/onlinelearning for more information and to order.

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Program Planning Committee

A Message from the Program ChairsDear Colleagues,

Over the last decade, there has been increased focus on improving pharmaceutical quality. The role of quality systems in achieving dependable quality has been an area of great focus, as there has been a realization that successful manufacturing organizations are effective if they are able to robustly manage risks throughout the product and facility lifecycle. To realize robust operational control and maintain a state of control requires vigilant systems for investigating emerging and existing operational problems. To address how this critical competency in a quality system is achieved, PDA and FDA have designed a unique workshop on Improving Investigations that will allow attendees to assess their systems, and conduct better investigations that lead to more sustainable quality and more reliable supply.

This meeting continues an ongoing series of FDA and PDA collaborations on quality systems, including last year’s successful ICH Q10 workshop on Executive Management Responsibilities, held in the Fall, 2012. These workshops are intended to help industry implement robust quality systems that ensure a sustainable state of control. Feedback by attendees of this workshop and previous quality systems conferences indicated that Investigations should be the next area of focus. FDA agreed, as “lack of adequate investigations” continues to be a top inspection observation globally and the lack of root cause resolution in some cases has led to persisting quality issues.

So we invite you to attend this carefully designed workshop, which will feature the insight of FDA and industry experts on investigating the root causes of manufacturing and quality problems, staffing an investigation, handling complaints, the impact of poor investigations, and tools that are increasingly used in the industry to better fulfill drug quality and business goals by resolving root causes. Through presentations and interactive breakout sessions, you will learn from industry and regulators about effective practices, and see illustrative case studies.

Interactive plenary and breakout sessions with ample opportunities to share and learn experiences and ideas will allow attendees to apply session knowledge and best practices to case studies in areas such as:

• Expectations and Benefits of a Well-Executed Investigation• Lab Investigations (investigating Out-of-Specification results)• Manufacturing Investigations• Supplier Investigations• Staffing and Scoping an Investigation• Executing an Investigation – The Essential Ingredients • Corporate Control and Vigilance• Assuring Effectiveness of Corrective Actions

Pharmaceutical industry professionals and regulators in the areas of Quality, Manufacturing, Supply Chain, Internal/External Audit, Regulatory Affairs, Technical Operations and Research & Development or anyone involved with the CGMPs are invited to attend this workshop.

A robust investigation program is crucial to all pharmaceutical companies and we believe attendees will benefit by learning how to enhance investigation competencies and systems investigations at their companies. This workshop will be a unique opportunity for participants to engage directly with FDA and industry experts to ask questions and share best practices that can be used to yield tangible, real life solutions that can be immediately applied in your daily activities.

Co-Chairs of the 2013 PDA/FDA Improving Investigations Workshop,

Co-Chair Richard Friedman FDA

Co-Chair Anders Vinther, PhD Genentech, Inc

Thomas J. Arista FDA

Jason E. Brown PDA

Nicholas Cappuccino, PhD Pharmaceutical Intellectual Resource Services LLC

Zena Kaufman Hospira

Jennifer Magnani F. Hoffmann-La Roche Ltd

Wanda Neal, CMP PDA

Swroop K. Sahota, PhD Catalent Pharma Solutions

Melissa SeymourBiogen Idec

Richard Friedman, Associate Director, OMPQ, CDER, FDA

Anders Vinther, PhD, Vice President, Quality Biologics Operating Unit, Global Quality, Genentech, Inc.

2013 PDA/FDA Improving Investigations WorkshopThe ICH Q10 Workshop Series: The Practical Approach to Sustainable ComplianceSeptember 18-19, 2013

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2013 PDA/FDA Improving Investigations WorkshopThe ICH Q10 Workshop Series: The Practical Approach to Sustainable Compliance

September 18-19, 2013 | Renaissance Washington Hotel | Washington, D.C.Exhibition: September 18-19 | Courses: September 19-20

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Wednesday, September 18, 2013 AgendaWednesday, September 18, 20137:00 a.m. – 5:00 p.m. Registration Open

1:30 p.m. – 1:45 p.m. Welcome and Opening Remarks Anders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc. and Richard Friedman, Associate Director, OMPQ, CDER, FDA, Co-Chairs, 2013 PDA/FDA Improving Investigations Workshop Program Planning Committee

1:45 p.m. – 3:15 p.m. P1 – Expectations and Benefits of a Well-Executed InvestigationSession Moderator: Thomas J. Arista, National Expert Investigator, ORA, FDA

This session will provide participants with an overview of FDA’s expectations, industry trends that they are encountering during inspections and examples of well managed investigations. Followed by industry’s view on how a well-executed investigation can add benefit financially (no repeat investigations) and from an overall compliance perspective and management review process and responsibility for investigations.

1:45 p.m. – 2:15 p.m. FDA’s Expectations, Observations (483’s/warning letters and Quality System Link to be discussed)FDA presenter invited

2:15 p.m. – 2:45 p.m. Benefits and Elements of Establishing an Investigation Process Juan Torres, Senior Vice President, Quality, Biogen Idec

2:45 p.m. – 3:15 p.m. Management Review and Responsibility for Investigations Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc.

3:15 p.m. – 3:45 p.m. Refreshment Break in Exhibit Area

3:45 p.m. – 4:45 p.m. Breakout Working Groups – Effective Investigations In all of the breakout sessions attendees will have a choice to work through one of three examples of investigations (Laboratory OOS, Manufacturing Issue, Supplier Issue). The same highly interactive approach will be followed for all three investigations and each session will build on the collective experience and creativity of the group. The combined outcome in the breakouts at each phase of the investigation will be gathered and condensed into points to consider when conducting investigations.

A1 – Lab Investigations B1 – Manufacturing Investigations C1 – Supplier Investigations

Industry Facilitator: Zena Kaufman, Senior Vice President, Global Quality, HospiraRegulatory Facilitator: FDA facilitator invited

Industry Facilitator: Anders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc.Regulatory Facilitator: FDA facilitator invited

Industry Facilitator: Swroop K. Sahota, PhD, Vice President, Quality Operations, Catalent Pharma SolutionsRegulatory Facilitator: Robert McElwain, Consumer Safety Officer, CBER, FDA

Scope and Content: An investigation team is formed, scope discussed and information and resources needed for conducting the investigation is summarized.

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Wednesday, September 18 – Thursday, September 19, 2013 Agenda

4:55 p.m. – 6:00 p.m. P2 – Staffing and Scoping an Investigation Session Moderator: Melissa Seymour, Senior Director, Corporate QA, Biogen Idec

This session will arm participants with techniques and key points to consider when establishing an investigation team from the functions to include on the team, to important skill sets required, and essential sponsorship and management notification process. It will also cover discussions on assessing the risk of a given investigation and how to appropriately bracket all impacted products, equipment and raw materials. Included in this topic will be a presentation on the timing of the various communications needed, how to involve management and when it is critical to involve the health authorities.

4:55 p.m. – 5:20 p.m.Forming an Investigation Team (Selecting the Right Subject Matter Experts, Investigation Team Leader and Management Sponsor)Swroop K. Sahota, PhD, Vice President, Quality Operations, Catalent Pharma Solutions

5:20 p.m. – 5:45 p.m. Deviations, Complaints, QC Failures, and other Investigations...How to Gauge Risk, When to Act, and Who to Inform Presenter to be announced

5:45 p.m. – 6:00 p.m. Q&A Discussion

6:00 p.m. – 7:00 p.m. Networking Reception in Exhibit Area

Thursday, September 19, 20137:30 a.m. – 5:00 p.m. Registration Open


8:30 a.m. - 10:00 a.m. Breakout Working Groups: Effective Investigations Attendees should attend the same breakout session topic as selected on the first day.





Execution: Various Root Cause Analysis (RCA) tools are discussed for relevance and a condensed version of the RCA is performed, product impact assessed, management is notified and it is decided if FAR/BPDR reporting is needed.

10:00 a.m. – 10:30 a.m. Refreshment Break in Exhibit Area

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2013 PDA/FDA Improving Investigations WorkshopThe ICH Q10 Workshop Series: The Practical Approach to Sustainable Compliance

September 18-19, 2013 | Renaissance Washington Hotel | Washington, D.C.Exhibition: September 18-19 | Courses: September 19-20

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Thursday, September 19, 2013 Agenda (continued)

10:30 a.m. – 12:00 p.m.P3 – Executing an Investigation – The Essential IngredientsSession Moderator: Zena Kaufman, Senior Vice President, Global Quality, Hospira

This section of the workshop will cover the essential elements to ensure an investigation is technically well written and comprehensive, including assessing quality impact and getting to the root cause of the failure. It will provide case studies of effective investigations by companies, and explain why each investigation was successful. Additionally, the session will discuss the use of root cause analysis tools and their major quality (and business) benefits.

10:30 a.m. – 11:00 a.m.Essentials Components of a Thorough InvestigationThomas J. Arista, National Expert Investigator, ORA, FDA

11:00 a.m. – 11:30 a.m. Getting to the Root Cause….Selecting and Utilizing the Right Tool Shane Ernst, Vice President of Quality, Hospira

11:30 a.m. – 12:00 p.m. Q&A/Discussion

12:00 p.m. – 1:00 p.m.Lunch

1:00 p.m. – 2:30 p.m. P4 – Corporate Control and Vigilance Session Moderator: Nicholas Cappuccino, PhD, CEO, Pharmaceutical Intellectual Resource Services LLC

This session will discuss the inputs to the Quality System that help trigger an investigation, such as PPPQMS, Management Review, Fundamental Importance of Management Support for major remediation’s, CAPA. The judgments made by the leaders at a firm, including how a good quality system determines in which instances a comprehensive investigation (rather than a less intense one) is needed that might require major investment to achieve corrections.

1:00 p.m. – 1:30 p.m.Reactive vs. Vigilant Quality Culture OutcomesJohn E. Snyder, President, John Snyder & Company, Inc.

1:30 p.m. – 2:00 p.m. Handling Customer Complaints - Listening to the Voice of the Customer Nikki Mehringer, Director of Quality, Global Patient Safety, Eli Lilly and Company (invited)

2:00 p.m. – 2:30 p.m. Q&A/Discussion

2:40 p.m. – 3:40 p.m. P5 – Assuring Effectiveness of Corrective Actions Session Moderator: Jennifer Magnani, Associate Director, Global Quality Systems, Genentech, Inc.

In this session the presenters will provide examples of corrective actions can be effective in preventing repeat issues and can be used to drive the business in a state of continual improvement. The importance of assessing if the CAPA remains effective over a period of time will be discussed, including the need for enhanced scrutiny following major changes to ensure there are not unintended consequences.

2:40 p.m. – 3:05 p.m. Identifying the Right Corrective Actions: Case Study on How to Use Six Sigma to Focus on the Sources of Variation Sharon Timmis, Vice President, Operational Excellence, Pfizer

3:05 p.m. – 3:30 p.m. How do you Assure Effective Corrective Actions? Veronica Cruz, Vice President, Quality and Compliance, McNeil Consumer Healthcare

3:30 p.m. – 3:40 p.m. Q&A/ Discussion


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Thursday, September 19, 2013 Agenda (continued)3:40 p.m. – 4:00 p.m. Refreshment Break in Exhibit Area

4:00 p.m. - 5:00 p.m. Breakout Working Groups: CAPA and Effectiveness of Investigations Attendees should attend the same breakout session topic as previously attended.





CAPA and Effectiveness of Investigations: The write-up of the investigation key points is performed and the investigation is concluded as it relates to final batch disposition as relevant. Short and longer term corrective and preventive actions are decided and final communication to management is completed.

5:10 p.m. – 6:00 p.m. P6 – Closing Plenary/Attendee Take-Away Roundtable Discussion Session Moderator: Richard Friedman, Associate Director, OMPQ, CDER, FDA and Co-Chair, 2013 PDA/FDA Improving Investigations Workshop Program Planning Committee

Attendees and facilitators discuss key elements of workshop that are developed into take-aways for attendees.

Panelists:Richard Friedman, Associate Director, OMPQ, CDER, FDA Mai Huynh, Chemist, CVM, FDAZena Kaufman, Senior Vice President, Global Quality, HospiraSwroop K. Sahota, PhD, Vice President, Quality Operations, Catalent Pharma SolutionsAnders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc. FDA panelist invited

6:00 p.m. Closing Remarks from Co-Chairs: Richard Friedman, Associate Director, OMPQ, CDER, FDA Anders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc

“I have been attending the PDA/FDA Joint Regulatory Conference for over 10 years and still find it to be

timely, informative and innovative in its approach to addressing regulatory and

quality cutting edge issues.”Susan Schniepp, Allergy Laboratories, Inc.

PDA/FDA Joint Regulatory Conference (Sept 16-18) and the Investigations Workshop (Sept 18-19)Renaissance Washington, (9th Street) Hotel | Washington, D.C. Courses: September 19-20

Registration is simple and fast... Click, fax or mail: Click: www.pda.org/pdafda2013 Fax: +1 (301) 986-1093 (USA); Mail: PDA Global Headquarters, 4350 East West Highway, Suite 150, Bethesda, MD 20814 USA

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2 Conference Registration | September 16-18, 2013 Please check appropriate fee (US$).

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Before July 8, 2013 $ 1,695 $ 1,944 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

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#447 Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Packaging and Labeling of Drug Products (September 20)

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#231 Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Case Studies in the Manufacturing of Pharmaceutical Drug Products (September 20)

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Register before July 9, 2013 and receive access to the 2012 PDA/FDA Joint Regulatory Conference recordings for 60 days.

Attendees receive a $200 discount when they register for both the conference and a course. This offer is not valid for government/health authority, academic or student registrations. Other discounts cannot be applied.

PDA global Headquarters4350 East West Highway, Suite 150Bethesda, MD 20814 USAPhone: +1 (301) 656-5900Fax: +1 (301) 986-0296

2013 PDA/FDA Joint Regulatory ConferenceSeptember 16-18, 2013Renaissance Washington Hotel Washington, D.C.Exhibition: September 16-17 Courses: September 19-20 www.pda.org/pdafda2013

2013 PDA/FDA Improving Investigations Workshop September 18-19, 2013 Renaissance Washington Hotel Washington, D.C.Exhibition: September 18-19 www.pda.org/investigations2013

Sponsorship and Exhibit Opportunities are Available for Both Meetings!High impact, cost-effective sponsorship and exhibition packages are available for both the PDA/FDA Joint Regulatory Conference and the PDA/FDA Investigations Workshop. Gain on-site exposure and connect with industry experts from manufacturing, quality, senior management, compliance, research and development, supply chain, and regulatory. The agenda provides ample time for exhibitors to make new contacts and network with attendees who will be seeking new solution and service providers. In addition, comprehensive sponsorship packages for both meetings will provide your company the opportunity to strengthen brand image, increase visibility, and reinforce its commitment to the biopharmaceutical industry. Sponsorships are also available for lanyards, USBs, notepads, pens, refreshment breaks, lunch, networking reception, and more.

2013 PDA/FDA Joint Regulatory Conference Exhibition: September 16-17

2013 PDA/FDA Improving Investigations Workshop Exhibition: September 18-19

Package Discounts Available to Sponsor and/or Exhibit at Both Meetings!

For exhibition and sponsorship inquiries, please contact:

David Hall, Vice President, Sales Tel: +1 (301) 656-5900 x 160 | Direct: +1 (240) 688-4405 | E-mail: [email protected]

Preliminary Agenda Inside

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