the parenteral drug association presents the pda … microbiology brochure.pdf · the parenteral...

EXHIBITION: OCTOBER 20-21 COURSES: OCTOBER 23-24

www.pda.org/microbiology2014

The Parenteral Drug Association presents the...

PDA 9th AnnualGlobal Conference

on PharmaceuticalMicrobiology

October 20-22, 2014BETHESDA NORTH MARRIOTT HOTEL & CONFERENCE CENTER

BETHESDA, MARYLAND

Register before August 11, 2014 and save up to $400!

THIS PRELIMINARY AGENDA IS CURRENT AS OF JUNE 25, 2014TAPE RECORDINGS ARE PROHIBITED AT ALL PDA CONFERENCES

2 www.pda.org/microbiology2014

Program PlanningCommittee

Connecting People, Science and Regulation®

Edward S. Balkovic, PhD, Genzyme – A Sanofi Company

Julie Barlasov, Perritt Laboratories, Inc

Renee Blosser, CVM, FDA

Marsha Hardiman, ConcordiaValSource

Deborah Havlik, Hospira, Inc.

Anna McLernon, PhD, Johnson & Johnson

Michael J. Miller, PhD, Microbiology Consultants, LLC

Amy McDaniel, PhD, Pfizer, Inc.

John Metcalfe, PhD, CDER, FDA

Cheryl Platco, Merck Research Laboratories

Edward Tidswell, PhD, Baxter Healthcare Corporation

Kim Sobien, Becton Dickinson Rx, Inc.

Marla Stevens – Riley, PhD, CDER, FDA

Radhakrishna S. Tirumalai, PhD, US Pharmacopeial Convention

PDA Staff:

Richard Levy, PhD, PDA

Leon Lewis, PDA

A Message from the Program Co-ChairsDear Colleagues:

On behalf of the program planning committee, we would like to invite you to attend PDA’s 9th Annual Global Conference on Pharmaceutical Microbiology held on October 20-22, 2014 in Bethesda, MD. This year our conference theme is Lessons from Today and Advice for tomorrow, and this year’s conference offers a selection of current and new scientific information and recent global regulations that ensure that we, as pharmaceutical microbiologists, are up-to-date and ready for the future. This conference maintains its reputation for offering invaluable sessions dedicated to pharmaceutical microbiology and for providing venue to network with fellow microbiologists, experts in all areas of pharmaceutical microbiology, key vendors of microbiology testing equipment and supplies and regulatory/compliance professionals.

The conference will commence with the keynote address, “Investigation of Norovirus Outbreaks and Disinfections of Cruise Ships” that will be presented by Jan Vinje, PhD, Head, National Caliciviruis Laboratory, Centers for Disease Control (CDC). This presentation will provide an overview of recent outbreaks of the Norovirus, the Disinfection protocols, the lessons learned and how it can be applied to our industry. Then, the conference moves to concurrent sessions on “Biofilms, Bioburden and Cleaning validation” and “Parameteric Release” with both sessions focusing on adapting new ways to ensure quality and expedite finished product release. In the afternoon’s concurrent sessions, one is devoted to sterile products manufacturing “Developing Sterilization technologies” and the other to Non-sterile products “Objectionable Microorganisms in Non-sterile Pharmaceutical Drugs.” Finally, we close the day with one of our favorite sessions “Urban Myths” where we will hear lots of Myths about Media Fills and a very interesting Regulatory Perspective.

We will be celebrating 50 years since the development of the LAL test on our second day, with a presentation from Jack Levin, MD, Professor of Laboratory Medicine, University of California School of Medicine, about the LAL test: From Past to Present. Dr. Levin will take us through a journey that started back in 1964 when the first LAL test was developed and all the development that this test went through until now. This test has, and continues to have, a big impact on our testing and finally on our products. This will be followed a concurrent sessions, one will focus on current topics dealing with the “Endotoxin testing” and the other will deal with “Micro data Deviations.” After a networking luncheon, another two concurrent sessions will resume – “Innovative Technologies” and “Risk Assessments” where new representative technologies and methodologies will be presents in one, and case studies and novel approaches for risk assessments will be discussed in the second. Finally, the day ends with one of our most popular sessions “Emerging Leaders.” This session provides an opportunity for new generation of early career scientists to share microbiological case studies and current issues.

The final conference day focuses on pharmaceutical microbiology standards and regulation. The “USP Updates” session will provide an overview of the proposed changes to USP general chapters related to Microbiology, and the remainder of the conference will be devoted to regulatory issues. A FDA regulator will present updates on domestic and global inspection issues, followed by conference attendees posing their pharmaceutical microbiology questions directly to FDA personnel with expertise in field and center issues in the “Ask the Regulators” panel discussion.

For a more interactive experience and a greater opportunity to learn about other pharmaceutical microbiology topics and technologies, during the first two days of the conference, poster presentations and vendor exhibits are available. In addition, on our third day, an interest group session will convene discussing the topic of sterile processing.

Lunches and refreshment breaks will provide a relaxed environment to discuss the issues raised during the day’s presentations, and the networking reception on Monday evening will allow time for visiting with vendors and fellow attendees.

For continuing education and training, PDA’s Training and Research Institute will offer several courses relevant to pharmaceutical microbiology and manufacturing immediately following the conference.

Please join us October 20-22 in Bethesda, MD, for this unique and interactive learning opportunity!

Sincerely,

Co-chairs PDA’s 9th Annual Global Conference on Pharmaceutical Microbiology Program Planning Committee.

Osama (Sam) Elrashidy Formerly with Bayer Healthcare Pharmaceuticals, Inc.

Kalavati Suvarna, PhD CDER, FDA

CO-CHAIRS

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www.pda.org/microbiology2014 3

PDA 9th Annual Global Conference on Pharmaceutical MicrobiologyOctober 20-22, 2014 | BETHESDA NORTH MARRIOTT HOTEL & CONFERENCE CENTER | BETHESDA, MARYLAND

EXHIBITION: OCTOBER 20-21 | COURSES: OCTOBER 23-24

General InformationSPECIAL 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].

CONTACT INFORMATION

Conference Inquiries: Leon D. Lewis Director, Programs and Meetings Tel: +1 (301) 656-5900 ext. 149 | Email: [email protected]

Registration Inquiries: Registration Customer Care Tel: +1 (301) 656-5900 ext. 115 | Email: [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) 760-7373 | Mobile: +1 (240) 688-4405 E-mail: [email protected]

Four Ways to Register

1. Click www.pda.org/microbiology2014

2. Call +1 (301) 656-5900 ext 115

3. Fax +1 (301) 986-1093

4. Mail PDA Global Headquarters Bethesda Towers 4350 East West Highway Suite 150 Bethesda, MD 20814 USA

VENUE

Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road Bethesda, MD 20852 Phone: +1 (301) 822-9200Website: www.marriott.com

Rate: Single: $249.00, plus applicable state and local taxes.

Cut Off Date: Sunday, September 28, 2014 (Rooms must be secured by this date in order to receive the PDA rate). Rates are guaranteed until the PDA block of rooms are sold out on a first come basis.

CONFERENCE REGISTRATION HOURS

Sunday, October 19: 4:00 p.m. – 6:00 p.m.Monday, October 20: 7:00 a.m. – 5:30 p.m.Tuesday, October 21: 7:00 a.m. – 5:15 p.m.Wednesday, October 22: 7:00 a.m. – 12:30 p.m.

COURSE REGISTRATION HOURS

Thursday, October 23: 7:30 a.m. – 4:00 p.m.Friday, October 24: 7:30 a.m. – 4:00 p.m.

DRESS/ATTIRE

Business casual attire is recommended for PDA 9th Annual Global Conference on Pharmaceutical Microbiology. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

PDA 9th Annual Global Conference on Pharm

aceutical Microbiology



Sunday, October 19 – Monday, October 20, 2014 AgendaSunday, October 19, 2014

4:00 p.m. – 6:00 p.m.Registration Open

Monday, October 20, 2014

7:00 a.m. – 5:15 p.m.Registration Open

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

8:00 a.m. – 8:15 a.m.Welcome and Opening RemarksOsama Elrashidy, Former Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc., Co-Chair, 9th Annual Global Conference on Pharmaceutical Microbiology Program Planning Committee

8:15 a.m. – 9:15 a.m.Plenary Session 1: Opening Keynote AddressModerator: Osama Elrashidy, Former Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc.

Session Description: CDC has been investigating many outbreaks of the Norovirus abroad cruise ships in the recent years. A major Part of this investigation is to oversee and ensure the effectiveness of the sanitization and disinfection of these huge vessels in a very short period of time. In This session, our presenter will provide us with an overview of these investigations and the protocols used for sanitization and disinfectant. Many lessons can be learned that can be applied at our pharmaceutical manufacturing facilities.

8:15 a.m. – 9:00 a.m.Investigation of Norovirus Outbreaks on Cruise Ships and How to Disinfect a Cruise ShipJan Vinjé, PhD, Head, National Calicivirus Laboratory, Division of Viral Diseases, Centers for Disease Control

9:00 a.m. – 9:15 a.m.Q&A/Discussion

9:00 a.m. – 6:45 p.m.Exhibit Hall Open

9:15 a.m. – 10:00 a.m. Refreshment Break and Poster Presentations in Exhibit Hall

10:00 a.m. – 12:00 p.m.Choose from 2 Concurrent Sessions

10:00 a.m. – 12:00 p.m.A1: Biofilms and Bioburden ControlModerator: Kalavati Suvarna, PhD, Sr. Microbiologist, CDER, FDA

10:00 a.m. – 12:00 p.m.B1: Parametric ReleaseModerator: Kim Sobien, Regulatory Compliance Lead, BD Rx, Inc.

Session Description: This session will present practical approaches to the prevention, detection and remediation of microbial contaminations that attendees can use in daily production and laboratory operations.

This session will also provide a series of case studies that will take the attendees through the situations and investigations to the root cause and lessons learned, providing insight to processes and practices used for bioburden issue resolution.

Session Description: Parametric release is a sterility release program that is founded upon effective control, monitoring and documentation of a validated sterile product manufacturing process where sterile product release is based upon demonstrated achievement of critical parameters in lieu of end product sterility testing (PDA TR No. 30-2012). Through a series of case studies, this session will provide attendees with industry and regulatory viewpoints on parametric release.

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Monday, October 20, 2014 Agenda (continued)

A1: Biofilms and Bioburden Control (continued) B1: Parametric Release (continued)

10:00 a.m. – 10:30 a.m.Bioburden and Biofilm Control Strategy and Case StudiesChris Knutsen, PhD, Associate Director, Microbiology, ABD, Bristol-Myers Squibb Company

10:30 a.m. – 11:00 a.m.Water System SanitizationIgor Gorsky, Senior Consultant Engineer, Packaging Development Laboratory, ConcordiaValSource LLC

11:00 a.m. – 11:30 a.m.Equipment Corrosion and Biofilm ControlMatthew Kennedy, Manager, Process Engineering, GlaxoSmithKline Shane Manning, Technology Manager, Biopharm Technology, GlaxoSmithKline

11:30 a.m. – 12:00 p.m.Q&A/Discussion

10:00 a.m. – 10:30 a.m.Regulatory Aspects of Parametric Release – Then and NowMarla Stevens – Riley, PhD, Team Leader/Senior Review Microbiologist, CDER, FDA

10:30 a.m. – 11:00 a.m. A Parametric Release Case StudyJeffrey Weber, Senior Scientist, PAT Projects, Pfizer, Inc.

11:00 a.m. – 11:30 a.m. Parametric Release – Advice for TomorrowMichael Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare Corporation


12:00 p.m. – 1:15 p.m. Exhibitor Roundtable Luncheon – Exhibitors will be seated at designated tables and will be available for informal discussion with attendees

1:15 p.m. – 3:15 p.m.Choose from 2 Concurrent Sessions

1:15 p.m. – 3:15 p.m. A2: Developing Sterilization TechnologiesModerator: Edward Tidswell, PhD, Director, Sterility Assurance, Baxter Healthcare Corporation

1:15 p.m. – 3:15 p.m. B2: Objectionable Microorganisms in Non-SterilePharmaceutical DrugsModerator: Julie Barlasov, Laboratory Manager, Perritt Laboratories, Inc.

Session Description: The use of new technologies for sterilization continues to evolve as product and packaging characteristics change. This session will look at several new approaches to sterilization, and how they can be applied to commercial manufacturing.

Session Description: Some of the recalls or extensive investigations of non-sterile products happen when objectionable organism is recovered. Determination of what objectionable organism is and what is the best methodology to use in order to ensure that the product/material is free of objectionable organisms (as required in CFR) is not clearly written in compendia or the CFR. This session will cover current trends of organisms that are or can be considered objectionable, methodologies that can be utilized to assure that objectionable organisms are excluded from product/material and effective ways to release product/material for use.

1:15 p.m. – 1:45 p.m.Electron Beam: New Potential for Healthcare ProductsJohn Logar, Director, Radiation Sterilization, Johnson & Johnson

1:45 p.m. – 2:15 p.m.Gama Sterilization of Polymeric Biocompatible for Transplantation ApplicationsFatima Hasanain, Polymer Materials Specialist, Nordion Inc

2:15 p.m. – 2:45 p.m.Electron Microscopic Imaging in the Support of InvestigationsJason Mantei, PhD, Research Scientist I, Baxter Healthcare Corporation

2:45 p.m. – 3:15 p.m.Q&A/Discussion

1:15 p.m. – 1:45 p.m.Objectionable Organisms Citation in Non-Sterile IndustryBarry Friedman, PhD, Consultant, Friedman Consultant, LLC.

1:45 p.m. – 2:15 p.m.Exclusion of Objectionable Organisms from Non-Sterile ProductsAnil Sawant, PhD, Vice President, Enterprise Regulatory Compliance, Johnson & Johnson

2:15 p.m. – 2:45 p.m.Approach to Microbiological Testing of Raw Materials Utilizing a Microbial Attributes and Incoming Risk Scoring SystemKim Bowers, Senior Scientist, Quality Science and Technology, Pfizer, Inc.






Monday, October 20 – Tuesday, October 21, 2014 Agenda3:15 p.m. – 4:00 p.m. Refreshment Break and Poster Presentations in Exhibit Hall

4:00 p.m. – 5:30 p.m. Plenary Session 2: Urban MythsModerator: Richard V. Levy, PhD, Senior Vice President, Science and Regulatory Affairs, PDA

Session Description: There has been an ever increasing emphasis on “science-based regulation,” which begs the question of how much of our common microbiological wisdom in the pharmaceutical industry is actually based on fact. This session will look at two important aspects of pharmaceutical microbiology from this perspective. The presenters will explore our current understanding and “best practice” with an eye to determine whether what we believe is reality is in fact rooted in “good science.”

4:00 p.m. – 4:30 p.m.Media Fills MythDona Reber, Global Quality Operations, Microbiology and Aseptic Support, Pfizer Inc.

4:30 p.m. – 5:00 p.m.Urban Myths and Pharmaceutical Products: A CDER Microbiology Regulatory PerspectiveJohn Metcalfe, PhD, Sr. Microbiology Reviewer, CDER, FDA


5:30 p.m. – 6:45 p.m.Networking Reception and Poster Presentations in Exhibit Hall – Sponsored in part by Charles River Laboratories

Tuesday, October 21, 2014

7:00 a.m. – 5:15 p.m.Registration Open

7:00 a.m. – 8:15 a.m. Continental Breakfast

8:15 a.m. – 9:15 a.m. Plenary Session 3: Day 2 Keynote AddressModerator: Kalavati Suvarna, PhD, Sr. Microbiologist, CDER, FDA

Session Description: The innovative, breakthrough development of the LAL reagent in 1964 has led to the three principle methods of LAL testing that are in use today: Gel-Clot, Turbidimetric and Chromogenic. Based on the physiological reactions of a biological entity – Limulus polyphemus – to the presence of endotoxin, the LAL test is an excellent example of how basic research can have a significant impact. This session will review the fundamentals of the test that transformed our industry, examine new, novel approaches to endotoxin research, testing and knowledge and discuss current trends, issues and hot topics related to endotoxin and LAL testing.

8:15 a.m. – 9:00 a.m.The Original Description of the Limulus Amebocyte Lysate (LAL) Test: From Past to PresentJack Levin, MD, Professor of Laboratory Medicine, University of California School of Medicine, San Francisco


9:00 a.m. – 4:00 p.m. Exhibit Hall Open

9:15 a.m. – 10:00 a.m. Refreshment Break, Poster Presentations and Passport Raffle Prize Drawing in Exhibit Hall

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Tuesday, October 21, 2014 Agenda (continued)

10:00 a.m. – 12:00 p.m.Choose from 2 Concurrent Sessions

10:00 a.m. – 12:00 p.m. A3: Endotoxin TestingModerator: Cheryl Platco, Principal Scientist, Merck Research Laboratories

10:00 a.m. – 12:00 p.m. B3: Micro Data Deviations Sterile and Non-SterileModerator: Marsha Hardiman, Senior Consultant, Concordia ValSource

Session Description: Low Endotoxin Recovery has been a concern for the past few years in response to the June 2012 “Guidance for Industry: Pyrogens and Endotoxin Questions and Answer,” response #3 concerning the stability of measurable endotoxin in product. Biological matrices, as well as certain placebo matrices, have demonstrated an inability to recover endotoxins when spiked directly into these products. This session will present important background information about how an endotoxin molecule exhibits pyrogenic effects, the differences between native and purified lipopolysaccharide and how experimental design can influence the outcome of the studies. There is valuable new data to present. This session will provide education and guidance to anyone testing biological and small molecule products for endotoxin. A representative of the FDA will also offer comments.

Session Description: Microbial contamination investigations are of critical importance in our industry when recovery of microorganisms occurs in test samples. Performing thorough, accurate and timely investigations is key to success in determination of root cause. Investigations are needed for all microbial data deviations including environmental monitoring and utility data excursions; raw material, in-process and product aberrant test results; and media fill and sterility test positive results. An update from the PDA Task Force working on the Technical Report for Microbial Data Deviations will be presented. In addition, determining sound assignable causes for sterility test failures will be discussed along with a regulatory perspective on failure investigations and industry trends.

10:00 a.m. – 10:30 a.m.Endotoxin Potency Change in the LAL Reactivity and its Relationship with PyrogenicityMasakazu Tsuchiya, PhD, Senior Research Scientist, Endotoxin and Microbial Detection, Charles River Laboratories

10:30 a.m. – 11:00 a.m. Low Endotoxin Recovery: New Data from LAL, MAT and Ligand Based Detection Methods Vs. Traditional Rabbit Pyrogen Test MethodJohn Dubczak, General Manager, Endotoxin and Microbial Detection, Charles River Laboratories

11:00 a.m. – 11:30 a.m. Endotoxin Challenges – A Regulatory PerspectiveRegulatory Speaker Invited

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

10:00 a.m. – 10:30 a.m.Micro Data Deviations Investigations Edward Balkovic, PhD, Principal Microbiologist, Contamination Control, Genzyme – A Sanofi Company

10:30 a.m. – 11:00 a.m.Sterility Test Failure InvestigationsKenneth Muhvich, PhD, Principal Consultant, Micro-Reliance, LLC

11:00 a.m. – 11:30 a.m.Regulatory PerspectiveDavid Hussong, PhD, Associate Director, New Drug Microbiology, CDER, FDA


12:00 p.m. – 1:15 p.m. Networking Luncheon





Tuesday, October 21, 2014 Agenda (continued)

1:15 p.m. – 3:15 p.m. A4: Innovative Technologies: Microbiology Testing Technologies Moderator: Michael Miller, PhD, President, Microbiology Consultants, LLC

1:15 p.m. – 3:15 p.m. B4: Risk AssessmentsModerator: Amy McDaniel, PhD, Director, Technical Operations, Pfizer, Inc

Session Description: “The art challenges the technology and the technology inspires the art.“ (John Lasseter). In contrast to traditional microbiological tools, new microbiological technologies are diverse, commercially expedient and measure microorganisms in means truly beneficial to assuring product quality. Traditional microbiological methods suffer from several well-identified issues, especially long lead time to results; therefore, Rapid Microbiological Methods represent a means to assure a higher level of quality, and improve the efficiency of manufacturing operations. This session examines representative technologies and methodologies; the presenters will also discuss the challenges.

Session Description: This session will provide case studies on practical and novel approaches for applying risk assessments. This session will explore QRM, Real Time Risk Assessments, as well as Risk Based EM.

1:15 p.m. – 1:45 p.m.Case Study on a Rapid Mycoplasma Detection AssayEsther Presente, Senior Specialist – QC, Amgen, Inc.

1:45 p.m. – 2:15 p.m.Innovative Technology: Use of Online Headspace Analysis for Media Fill InspectionTony Cundell, PhD, Consulting Microbiologist

2:15 p.m. – 2:45 p.m.Rapid Detection and Quantification of Microbial Contaminants in Process Water by Flow Cytometry Yongqiang Zhang, PhD, Senior Scientist, Becton Dickinson Diagnostic


1:15 p.m. – 1:45 p.m.Risk Based Environmental MonitoringMarsha Stabler Hardiman, Senior Consultant, Concordia ValSource

1:45 p.m. – 2:15 p.m.Real Time Risk AssessmentsDaniel Hrnciar, Research Scientist I, Baxter Healthcare Corporation

2:15 p.m. – 2:45 p.m.Profound Risk Assessment Using Hazard Analysis and Critical Control Point to Control Biologic Contamination During Manufacturing of Biologic Products Lada Laenen, PhD, Manager, Cell Culture and Microbiology Technology Department, Genzyme – A Sanofi Company


3:15 p.m. – 3:45 p.m.Refreshment Break, Poster Presentations and Passport Raffle Prize Drawing in Exhibit Hall

3:45 p.m. – 5:00 p.m. Plenary Session 4: Emerging LeadersModerator: Osama Elrashidy, Former Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc.

Session Description: This session is mainly designed to explore the new generation of microbiologist and to give them the opportunity to share their ideas and views on the most current topics and challenges that faces all microbiologists in general. The goal is to hear new voices with new faces discussing the daily problems that exist in the day-to-day activities within any Microbiology lab. A select group of junior managers from across the industry, with hands-on experience, will have the chance to present their current issues and challenges and the way they were able to resolve them. Also, they will be able to raise their questions and concerns to all attendees.

3:45 p.m. – 4:00 p.m.Identifying the Rocks, Pebbles and Stones in your Microbiology LaboratoryLeslie Falco, Quality Scientist II, Pfizer Biotech

4:00 p.m. – 4:15 p.m.Behind the Curtain: Planning A Secret Isolator EM ProgramShannon Vick, QC Microbiologist, BD Rx Inc.

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Tuesday, October 21 – Wednesday, October 22, 2014 Agenda

Plenary Session 4: Emerging Leaders (continued)

4:15 p.m. – 4:30 p.m.Bugs on the Fast Track: Rapid Environmental Monitoring on the Manufacturing FloorLindsey Colvin, Manufacturing Scientist, Pfizer Specialty Biotech

4:30 p.m. – 4:45 p.m.Question Everything – Building an Environmental Monitoring Program on a Firm FoundationJonathan Stewart, QC Microbiology Manager, Baxter Healthcare Corporation


Wednesday, October 22, 2014

7:00 a.m. – 12:30 p.m. Registration Open

7:00 a.m. – 8:15 a.m. Continental Breakfast

7:00 a.m. – 8:00 a.m. Interest Group Session IG: Sterile Processing Moderator: Edward Tidswell, PhD, Director, Sterility Assurance, Baxter Healthcare Corporation

Session Description: During this interest group meeting, aspects from PDA’s updated Aseptic Processing Survey will be discussed. Input from the attendees is encouraged and welcomed.

8:15 a.m. – 9:30 a.m. Plenary Session 5: USP UpdatesModerator: Radhakrishna S. Tirumalai, PhD, Principal Scientific Liaison, US Pharmacopeial Convention

Session Description: Compatible with its overall mission, the role of USP in Microbiology is to develop public standards pertaining to microbiology that, along with other requirements, ensure the consistent quality of products. This session will provide an overview on current activities of the USP General Chapters-Microbiology Expert Committee relative to revisions to existing chapters and new chapter proposals.

8:15 a.m. – 8:40 a.m.Current Status of <1229> Sterilization and <1228> Depyrogenation – Series of ChaptersRadhakrishna S. Tirumalai, PhD, Principal Scientific Liaison, US Pharmacopeial Convention

8:40 a.m. – 9:05 a.m.Revisions Proposed to USP <1223> Validation of Alternative Microbiological MethodsJames E. Akers, PhD, Chair, USP General Chapters-Microbiology Expert Committee


9:45 a.m. – 10:30 a.m. Plenary Session 6: Day 3 Keynote Address – Regulatory UpdatesModerator: John Metcalfe, PhD, Sr. Microbiology Reviewer, CDER, FDA

Session Description: This address will highlight the recent experiences from the complementary perspective of an FDA Inspector to provide valuable insight into the regulatory expectations for the development, validation and ongoing control of sterile product manufacturing processes.





Wednesday, October 22, 2014 Agenda (continued)

Plenary Session 6: Day 3 Keynote Address – Regulatory Updates (continued)

9:45 a.m. – 10:15 a.m.Microbiology Inspections – A Regulatory Update Regulatory Keynote Invited


10:30 a.m. – 11:00 a.m. Refreshment Break

11:00 a.m. – 12:30 p.m. Plenary Session 7: Ask the Regulators Panel DiscussionModerator: Marla Stevens – Riley, PhD, Team Leader/Senior Review Microbiologist, CDER, FDA

Session Description: Participants will obtain information from a regulatory perspective about common microbiological challenges encountered in the manufacturing of drug products. Representatives from the FDA and other regulatory agencies will participate in the panel discussion. This session will be structured in question and answer format.

Regulatory Panelists Invited

12:30 p.m. – 12:40 p.m. Closing Remarks Kalavati Suvarna, PhD, Sr. Microbiologist, CDER, FDA and Co-Chair, 9th Annual Global Conference on Pharmaceutical Microbiology Program Planning Committee

Continuing EducationPDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Following full attendance, completion and submission of the appropriate evaluation forms, certificates will be

mailed within four to six weeks of the event. Continuing Education Units (CEUs) will be awarded as follows:

PDA 9th Annual Global Conference on Pharmaceutical MicrobiologyACPE # 0116-0000-14-043-L04-P | 1.625 CEUsType of Activity: Knowledge

LEARNING OBJECTIVES:

At the completion of this conference attendees will be able to:

· Discuss many areas of microbiology on topics such as managing microbial risk, microbial contamination and risk management in aseptic processing/manufacturing

· Identify current trends in microbiology (new technologies in both testing and sterilization)

· Implement appropriate strategies for maintaining a non-sterile manufacturing environment (the importance of microbial identification, testing for and understanding the impact of objectionable organisms and resolving microbial challenges associated with non-sterile operations)

· Summarize new advances in rapid microbiological methods, microbial identification technologies, endotoxin testing.

· Explain the elements of microbiology data deviations

· Identify local regulatory and pharmacopeial expectations

WHO SHOULD ATTEND:

Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation

Level of Expertise: Executives, Management, Scientists/Technicians

Job Function: Scientist/Technician, Research, Analyst, Bench personnel

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aceutical Microbiology Poster Presentations

Poster PresentationsListed in Alpha Order by Author Last Name

Fast and Efficient Co-Detection of Viruses and Mycoplasma in Mammalian Cell Cultures Vincent Beguin, Compliance Specialist, Merck Millipore

Direct Identification of Industry Relevant Bacteria and Yeast from Positive BacT/ALERT Media Using the VITEK® MSCarolyn Beres, Senior Scientist, bioMerieux

Application of Milliflex® Rapid for Sterility Testing of Antibiotics, Vaccines and Cell Cultures Beth Brescia, Application Scientit, Rapid Micro Methods, EMD Millipore

Risk Based Approach to Manage Biologic Products Exhibiting Low Endotoxin Recovery (LER) Joseph Chen, PhD, Head of Global QC Microbiology, Genentech, Inc.

Conducting an Endotoxin Matrix Interference and Sample Storage Study Relevant for Manufacturing of a Biologic Product Ruth Daniels, PhD, Head, Microbiology Operational Technical Support and Manufacturing Science Group, Genzyme – A Sanofi Company

Single Use Systems in Microbiological Environmental Monitoring Claudio Denoya, PhD, Senior Applications Scientist/Technology Consultant, Particle Measuring System

An Assessment for Implementation of the Endosafe Nexus Robotic Endotoxin Testing System Michael Estepp, Principal Analyst, Genzyme – A Sanofi Company

Evaluation of the Effect of the Volume Through Put and Maximum Flux of Low Surface Tension Fluids on Bacterial Penetration of 0.2 µM Rated Filters Martha Folmsbee, PhD, Principal Scientist, Pall Corporation

A New Era for Environmental Monitoring for Viable Particles Boaz Granot, Field Application Specialist – Biotechnology, TSI Incorporated

Biofilm Formation & Remediation with USP Pretreatment System: A Case Study Julie McKinney, PhD, Senior Manager Microbiology & Raw Materials, Pfizer Consumer Healthcare

Development of qPCR Method for Leptonema Illini as Quantitation for Leptospira Membrane Retention Corinne Miller, PhD, R&D Manager, Virology & Microbiological Sciences, Process Solutions, EMD Millipore Corporation

Development of Bioburden Test Method Suitable for Mammalian Cell Culture Containing Antibiotics Youwen Pan, PhD, QC Scientist, Genentech, Inc.

Rapid Detection of Yeast in Guar Gum using Flow Cytometry in Conjunction with Selective Enrichment Media Vikram Patel, Staff Scientist, Becton Dickinson Diagnostics

Container Closure Integrity Testing – How to Improve an Established Method Jamie Perkins, Quality Control Scientist, Pfizer, Inc.

The Industry Best Practices in Disinfectant Coupon Testing James Polarine, Technical Service Manager, Steris Corporation

De-Masking of Endotoxin in Common Formulations of Biopharmaceuticals Johannes Reich, PhD Student (MSC), University Regensburg

Effect of MALDI-TOF Library Development on the Efficiency of Operations and Trending and Tracking Capability Anne Russell, PhD, Senior Staff Scientist, Charles River Laboratories

Efficient Mycoplasma Concentration Technique for Increasing Real-time PCR Sensitivity in Large Sample Volumes Alexandra Scholz, PhD, Scientist, R&D Microbiology, Sartorius Stedim Biotech

Alternative Growth Media for the Sterility Test Kate Shara, PhD, Scientist II, Rapid Micro BiosystemsSommer Vogel, Research Associate, Rapid Micro Biosystems

Examination of Factors for Improved Sample Collection for Environmental Surface Monitoring Kathleen Souza, Senior Research Scientist, EMD Millipore

Case Study – Evaluation of Medical Device Challenged with a Biofilm Bioburden Laura Wahlen, Research Associate, Baxter Healthcare Corporation



PDA’s Training and Research Institute (PDA TRI) Courses – October 23-24, 2014

Regulatory Aspects of Microbiology in a Non-Sterile EnvironmentOctober 23, 2014 Bethesda North Marriott Hotel and Conference Center PDA # 221 | ACPE# 0116-0000-14-031-L04-P | 0.6 CEUsType of Activity: Knowledge

COURSE DESCRIPTION

Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal when compared to aseptic manufacturing. These include the handling and evaluation of non-sterile components, the environment and final product. This course discusses various regulations and how they impact non-sterile manufacturing to include the setting of specification, development of the process, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Thoughts regarding in-house microorganisms that may be considered as “specified” will also be discussed. A “Case Study” will also be included where teams will discuss some of the various regulatory issues that are encountered in a plant environment and report their findings to all of the participants.

WHO SHOULD ATTEND

This course is for individuals in quality assurance/quality control, regulatory compliance, manufacturing, research & development, technology transfer and project management.

LEARNING OBJECTIVES

Upon completion of this course, you will be able to:

• Identify microbiological regulatory concerns with non-sterile in-coming components, in-process, active pharmaceutical ingredients (API) and finished product

• Discuss key microbiological issues involved in the manufacturing of non-sterile products

• Review the establishment of a non-sterile microbiological control program

• Identify gaps with current regulatory and industry expectations

• Learn how DRAFT USP<1115> Bioburden Control of Non-Sterile Drug Substances and Products complements the development of non-sterile products

PREREQUISITES

Individuals will benefit having a basic background in the sciences including biology (microbiology) or chemistry and basic familiarity with the various regulations to include: 21 CFR 211, FDA Guidance documents, EMA and Health Canada guidance and/or ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – ICH Harmonized Tripartite Guideline, November 2000.

INSTRUCTOR

Barry Friedman, PhD, Consultant, Barry A. Friedman, PhD, LLC

A Risk-Based Approach to Global Environmental ComplianceOctober 23, 2014Bethesda North Marriott Hotel and Conference Center PDA # 462 | ACPE# 0116-0000-14-030-L04-P | 0.6 CEUsType of Activity: Knowledge

COURSE DESCRIPTION

This course will provide students with the knowledge and skills needed to create a meaningful, manageable and defendable environmental monitoring program. Topics will include regulatory requirements, ISO requirements, validation, justification of sample sites and risk assessment of sample locations. Regulatory citations will be assessed and case studies will be used. The purpose of the course is to reduce microbial contamination in aseptic processing by means of risk reduction for environmental monitoring.

WHO SHOULD ATTEND

Microbiology and regulatory personnel in quality control/quality assurance, manufacturing, quality systems and validation will benefit from this course. This course is also for individuals involved with deviations and corrective actions.

In conjunction with the PDA 9th Annual Global Conference on Pharmaceutical Microbiology, the PDA Training and Research Institute (PDA TRI) is offering four stand-alone courses related to the latest technologies, learning resources and regulatory expectations in regards to microbiology. All courses will be held on October 23-24 at the:

BETHESDA NORTH MARRIOTT HOTEL AND CONFERENCE CENTER 5701 Marinelli Road, Bethesda, MD 20852

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PDA’s Training and Research Institute (PDA TRI) Courses (continued)

be highlighted from the literature concerning product contamination, infection outbreaks, product recalls and the clinical experience with canonical pathogens and other opportunistic microorganisms at the site of administration of the non-sterile product. A risk-based approach will be taken because a microorganism isolated from a product cannot be considered objectionable without considering the product attributes, number of organisms as measured by colony-forming units (cfu), their potential pathogenicity, ability to grow in the product and the intended use of the product.

Risk mitigation including ingredient selection, the effect of unit manufacturing processes on product bioburden, environmental controls, product formulation, microbial specification setting, release and stability testing, risk assessment and product failure investigation will be highlighted using recent industry case histories.

WHO SHOULD ATTEND

Managers, supervisors and individual contributors in product development, manufacturing, microbiology testing, quality assurance and regulatory affairs will benefit from this course.

LEARNING OBJECTIVES


• Understand the regulatory requirements surrounding objectionable microorganisms

• Conduct risk assessments for ingredients, packaging components, product design and formulation, manufacturing processes, facility design and product testing to address the exclusion of objectionable microorganisms

• Conduct risk assessments to determine if microorganisms found in a specific products are objectionable

• Develop risk-based microbiological specifications and testing programs that address a range of products

• Establish a corporate objectionable microorganism policy

PREREQUISITES

A basic understanding of risk management principles, microbiology and manufacturing processes will be helpful to participants in this course.

INSTRUCTOR

Tony Cundell, PhD, Consulting Microbiologist

LEARNING OBJECTIVES


• Identify environmental monitoring risk points

• Justify EM locations

• Evaluate viable air and total particle equipment

• Optimize your company’s current EM program to comply with global regulatory requirements

INSTRUCTOR

David Matsuhiro, President, Cleanroom Compliance, Inc.

Exclusion of Objectionable Microorganisms from Pharmaceutical and OTC Drug Products, Consumer Health Products, Medical Devices and CosmeticsOctober 24, 2014Bethesda North Marriott Hotel and Conference Center PDA # 114 | ACPE# 0116-0000-14-038-L04-P | 0.6 CEUsType of Activity: Knowledge

COURSE DESCRIPTION

This course, derived from the work of the PDA objectionable microorganism task force, covers the exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products, over-the-counter drug products, medical devices, cosmetics and personal care products in the Pharmaceutical, Medical Device, Cosmetics and Consumer Healthcare Industries. Objectionable microorganisms, as cited in 21 CFR 211.113, are those microorganisms that, if they persist and grow in non-sterile products, can cause harm to the user of the products and degrade the physicochemical, functional and therapeutic attributes of the products. The contamination of marketed products with so-called objectionable microorganisms continues to be an infrequent but chronic problem for both regulators and our industry.

A recent U.S. survey of 144 recalls of non-sterile branded pharmaceutical drug products (5%), over-the-counter drug products (42%), cosmetics (31%), medical devices (14%) and dietary supplements (8% of the total recalls) for microbiologically-related issues between 2004 and 2011 highlighted that the majority of these recalls (72%) were associated with objectionable microorganisms.

The course will provide guidance on how to manage the microbial risks associated with objectionable microorganisms within a specific product that meet the microbial limits requirements for release to the market. A product that exceeds the limit with respect to microbial count and contains compendial specified microorganisms would be rejected. No definitive list of objectionable microorganisms will be provided in this course, but microorganisms of potential concern will


aceutical Microbiology Course Series



PDA’s Training and Research Institute (PDA TRI) Courses (continued)

WHO SHOULD ATTEND

Individuals from the following areas will benefit from attending this course:

• Manufacturing / Facility Management

• Product Development

• Project Management

• QA/QC

• Microbiology

• Validation

LEARNING OBJECTIVES


• Identify the aspects of pharmaceutical manufacturing which may affect microbiological quality

• Develop an FMEA, quantifying risk for individual process steps

• Quantitatively evaluate steps within a process

• Develop ways to reduce or minimize activities that may increase microbial contamination risk

INSTRUCTOR

Peter Noverini, Field Applications Scientist, Azbil BioVigilant, Inc.

Microbiological Risk Assessment of a Pharmaceutical Manufacturing ProcessOctober 24, 2014Bethesda North Marriott Hotel and Conference Center PDA #382 | ACPE# 0116-0000-14-032-L04-P | 0.6 CEUsType of Activity: Knowledge

COURSE DESCRIPTION

This course is designed for quality and manufacturing professionals to develop a microbiological risk assessment based on specific pharmaceutical products or processes. Participants will learn to formulate a strategy to proactively look for areas of potential microbial contamination and minimize activities or processes that may cause risk.

Specific activities will include:

• Reviewing how microbiological quality may be impacted in steps throughout the manufacturing process

• Identifying risk assessment tools, including the Failure Modes and Affects Analysis (FMEA) approach

• Creating an example FMEA, incorporating process steps that may have microbial contamination risk

• Using the FMEA approach to evaluate process and behavior

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PDA 9th Annual Global Conference on Pharmaceutical Microbiology (October 20-22, 2014)Bethesda North Marriott Hotel & Conference Center | Bethesda, MDExhibition: October 20-21 | Courses: October 23-24

Four easy ways to register – Click, fax, mail or call: Click: www.pda.org/Microbiology2014 Fax: +1 (301) 986-1093 (USA); Mail: PDA Global Headquarters, 4350 East West Highway, Suite 150, Bethesda, MD 20814 USA; Call: + 1 (301) 656-5900 ext 115

1 Contact Information PDA Membership Number:

Prefix Name (Last, First, MI)

Job Title Company

Business Address

City State/Province ZIP+4/Postal Code

Country Email

Business Phone Fax

Substituting for

2 Conference Registration | October 20-22, 2014 Please check appropriate fee (US$).

Government/Health Authority Academic StudentPDA Member Nonmember Member Nonmember* Member Nonmember* Member Nonmember*

Before August 11, 2014 $ 1,695 $ 1,944 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

August 11 – September 9, 2014 $ 1,895 $ 2,144 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

After September 9, 2014 $ 2,095 $ 2,344 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

3 Course Registration | October 23-24, 2014 Please check appropriate fee (US$).

Price On or Before September 9, 2014 Price After September 9, 2014

StandardGovernment/Health Authority/Academic Standard

Government/Health Authority/Academic

Member Nonmember Member Nonmember Member Nonmember Member Nonmember#462 A Risk-Based Approach to Global Environmental Compliance (October 23) $ 985 $ 1,255 $ 600 $ 700 $ 1,095 $ 1,395 $ 600 $ 700

#221 Regulatory Aspects of Microbiology in a Non-Sterile Environment (October 23) $ 985 $ 1,255 $ 600 $ 700 $ 1,095 $ 1,395 $ 600 $ 700

#114 The Exclusion of Objectionable Microorganisms from Pharmaceutical and OTC Drug Products, Consumer Health Products Medical Devices and Cosmetics (October 24)

$ 985 $ 1,255 $ 600 $ 700 $ 1,095 $ 1,395 $ 600 $ 700

#382 Microbiological Risk Assessment of a Pharmaceutical Manufacturing Process (October 24) $ 985 $ 1,255 $ 600 $ 700 $ 1,095 $ 1,395 $ 600 $ 700

4 Payment Options All cards are charged in US$.

By Credit Card – Clearly indicate account number, expiration date and billing address. Please bill my: American Express MasterCard VISA

Total amount $ Credit Card Guarantee Only

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Wire Transfer Payments: If you require wire transfer, please contact [email protected].

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by August 21, 2014 your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). REFUNDS FOR FULL CONFERENCE/EVENTS: If your written request in received on or before August 21, 2014 you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900. PLEASE NOTE THAT PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ON-SITE. THIS IMPORTANT SECURITY PROCEDURE WILL PREVENT ANYONE OTHER THAN THE REGISTRANT FROM PICKING UP THEIR BADGES AND MATERIALS. REFUNDS FOR COURSES: If your written request is received by September 23, 2014, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. RECORDING/PHOTO RELEASE: By registering for this event, I authorize PDA the right to record and photograph me to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA conferences.

PDA USE ONLY Date: Check: Amount: Account:

PDA Federal Tax I.D. #52-1906152

Special Dietary Requirements (Please be specific):

Check Here to Become a member and receive the member price for this event. (Add $259 to your total.)

Group Registration: Register 4 people from the same organization as a group (at the same time) for the conference and receive the 5th registration free. Other discounts cannot be applied. All forms MUST be faxed in together.

Please note: In order to receive the prevailing rate, your registration(s) with payment must be received by PDA by 5:00 p.m. ET on or before the date noted.* For this member type or discounted rate, online registration is not available and must be faxed in.

1020

(Check only if you are substituting for a previously enrolled colleague; The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)


PDA 9th Annual Global Conference on Pharmaceutical MicrobiologyOctober 20-22, 2014 BETHESDA NORTH MARRIOTT HOTEL & CONFERENCE CENTER | BETHESDA, MARYLANDEXHIBITION: OCTOBER 20-21 | COURSES: OCTOBER 23-24

Sponsorship and Exhibit Opportunities are Available! The PDA 9th Annual Global Conference on Pharmaceutical Microbiology will provide your company an exclusive opportunity to gain access to, and network with key decision makers from the pharmaceutical and biotech manufacturing industry. Find new customers and strengthen current relationships by exhibiting at or sponsoring the industry’s leading conference for professionals involved in the field of pharmaceutical microbiology.

Attendees will include industry professionals from microbiology, manufacturing, compliance, quality, research and development, engineering, validation, regulatory affairs as well as executives, managers, scientists, technicians and analysts.

Become a sponsor and/or exhibit at the PDA 9th Annual Global Conference on Pharmaceutical Microbiology and strengthen your brand image, increase your visibility and gain access to leaders and subject matter experts in the biopharmaceutical industry

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, Sales | Direct: +1 (301) 760-7373 | Cell: +1 (240) 688-4405 | E-mail: [email protected]

PDA GLOBAL HEADQUARTERS4350 East West HighwaySuite 150Bethesda, MD 20814 USAPhone: +1 (301) 656-5900Fax: +1 (301) 986-0296

PDA 9th Annual Global Conference on PharmaceuticalMicrobiologyOctober 20-22, 2014BETHESDA NORTH MARRIOTT HOTEL & CONFERENCE CENTER BETHESDA, MARYLANDEXHIBITION: OCTOBER 20-21 COURSES: OCTOBER 23-24


Register beforeAugust 11, 2014

and save upto $400!

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