the parenteral drug association presents: 3 rd pda europe … · terumo 2 brevetti angela 4 altran...

3rd PDA Europe Annual Meeting

PDA Europe Conference, Exhibition, Education

The Parenteral Drug Association presents:

26-27 June 2018Marriott Hotel

Berlin | Germany

Global Healthcare of the Present & the Future

2 pda.org/EU/Annual2018

Dear Colleagues,

On behalf of the scientific program planning committee, we would like to invite you to the 3rd PDA Europe Annual Meeting held in Berlin / Germany, 26-27 June 2018.

The ongoing theme of the European Annual Meeting is Global Healthcare of the Present & the Future, as it intends to continue spanning a bridge between current demands within the global healthcare industry, the amounting advanced technological and analytical opportunities and the promising prospects personalized medicine and medicinal products bring.

The meeting will also include presentations from regulatory, industry and technology representatives from around the world. A comprehensive exhibition including a Poster Session to catch

up on the latest developments will give you the opportunity to network and interact with speakers and fellow attendees.

As is customary for PDA, the event will be accompanied by Interest Group Meetings, a thorough Education Program, and a diverse Exhibition Floor, offering plenty of food for thought, inspiration and networking opportunity.

We look forward to meeting you in Berlin this summer!

Sincerely,

The Chairs,

LETTER FROM THE CHAIRS

SCIENTIFIC PL ANNING COMMIT TEE

Jette Christensen, Novo Nordisk, Conference Chair

Borke Van Belle, Janssen J&J, Conference Chair

Barbara Allen, Eli Lilly

Maik Jornitz, G-CON Manufacturing

Aidan Harrington, DPS Group

Ulrike Malordy, PQE

Toni Manzano, Bigfinite

Yves Mayeresse, GSK Vaccines

Christopher Procyshyn, Vanrx

Falk Klar, PDA Europe

Sylvia Becker, PDA Europe, Manager Programs & Events

Jette Christensen, Novo Nordisk, Conference Chair

Borke Van Belle, Janssen J&J, Conference Chair

https://pda.org/EU/Annual2018

M E D I A PA R TN E R

S C H E D U L E A T A G L A N C E

25 June 10:00 – 17:00 Quality Systems Interest Group Meeting

25 June 10:00 – 17:00 Freeze Drying Technology Interest Group Meeting

26 June 9:00 – 18:00 3rd PDA Europe Annual Meeting Conference, Exhibition

26 June 18:00 – 22:30 Networking Dinner

27 June 9:00 – 16:30 3rd PDA Europe Annual Meeting Conference, Exhibition

28 June29 June

9:00 – 17:45 9:00 – 16:30

Practical Approach to Quality Culture Training Course

28 June29 June

9:00 – 17:00 9:00 – 16:30

Best Compliance Practice in a GMP Regulated Testing Laboratory

Training Course

28 June29 June

9:00 – 17:45 9:00 – 15:30

Test-Methods forPre-filled Syringe Systems

Training Course

Join @PDA_Europe on Twitter and post pictures and highlights of this meeting! #pdaeuannual

Follow us on LinkedIn http://linkedin.com/company/pda

26 June 2018 18:30h

Meeting Point: Hotel Lobby Joint Bus Transfer

19:00h Dinner, Boat Cruise through Berlin

22:00h Bus Transfer back to Conference Hotel

The Parenteral Drug Association is proud to invite you to a very special Networking Dinner.Join us for a great evening cruise through Berlin on the Spree river and be entertained by our very own PDA Band.

PDA Band

Playing Live

Aboard!

HEADBANGED BY


INTEREST GROUP MEETING

PDA is happy to announce the launch of the Interest Group Quality Systems!

As usual for any PDA Interest Groups, members are offered the possibility to discuss around their specific topic of interest, via an online forum and face-to-face as part of a conference.

As a kick-off to this year’s 3rd PDA Europe Annual Meeting, the Interest Group Quality Systems will meet in Berlin for the first time to present following ideas:

Presentations around:

• Quality Management Systems

• Integration of Quality Risk Management in QMS

• Best Practices for conducting Management Reviews

Group Discussions on the topics of:

• Management Review

• KPIs / Metrics

• CPV

• Process Owner

• Quality Risk Management

• Comparability of ICH Q10 with ISO

• Knowledge management

• PQS Implementation

• Processes / Flow Charting

You do not need to be a PDA member to register for this meeting. Everybody is welcome!

Quality Systems

Lothar Hartmann, PhD, PhACT GmbH IG Leader


7pda.org/EU/Annual2018

INTEREST GROUP MEETING AGENDA

19 Jun 2018

Monday, 25 June 2018

INTRODUCTION

10:00 Welcome Coffee All

10:30 Introduction of Participants Lothar Hartmann, PhACT

PRESENTATIONS

11:00 View on Quality Management System Advances and their impact on the manufacturing of the future

Michele Simone, Bracco

11:45 Integration of Quality Risk Management into a Quality Management System

Eva Urban, Celgene

12:30 Lunch Break

PRESENTATION

13:30 How to Conduct Management Reviews Katjusa Kreft, Novartis

ROUNDTABLE DISCUSSION

14:15 Quality Manual StructureVarious approaches

15:00 Coffee Break

DISCUSSIONS

15:30 Brainstorming Session on Sub-Group Topics:• Management Review

• KPIs / Metrics

• CPV

• Process Owner

• Quality Risk Management

• Comparability of ICH Q10 with ISO

• Knowledge management

• PQS Implementation

• Processes / Flow Charting

17:00 End of IG Meeting



INTEREST GROUP MEETING

PDA Interest Groups offer members the possibility to discuss around one specific main topic, via online fo-rum and face-to-face as part of a conference.

As a kick-off to this year’s 3rd PDA Europe Annual Meeting, the Interest Group Freeze Drying will meet in Berlin to present following ideas:

Presentations around:

• Technical Evolution in Term of Cooling Equipment for Freeze-Dryer

• State of the art validation approach for freeze-dried products

Group Discussions on the topics of:

• How to assess equipment equivalence

• How to assess process equivalence for validation

• What is the minimum load to be validated in a freeze-dryer

• What the link between leak rate and sterility of the freeze-dryer

• How to implement and use PAT tools such as NIR, Pirani/MKS

You do not need to be a PDA member to register for this meeting. Everybody is welcome!

Freeze Drying Technology

Yves Mayeresse, PhD, GSK VaccinesIG Leader



INTEREST GROUP MEETING AGENDA

19 Jun 2018

Monday, 25 June 2018

INTRODUCTION

10:00 Welcome and Opening of the Meeting Yves Mayeresse, GSK Vaccines

10:10 Introduction of Participants All

PRESENTATION

10:30 Technical Evolution in Term of Cooling Equipment for Freeze-Dryer• The regulation on accepted gas for refrigeration is evolving

to a greener state

• The refrigerant type for cooling at low temperature become rare

• Liquid nitrogen is an alternative for low temperature cooling

• There’s equally a trend towards new type of natural refrigerant

Thomas Beutler, GEA

12:00 Lunch Break

PRESENTATION

13:00 State of the Art Validation Approach for Freeze-Dried Product

ROUND TABLE DISCUSSIONS

13:45 • How to assess equipment equivalence

• How to assess process equivalence for validation

• What the minimum load to be validated in a freeze-dryer

15:30 Coffee Break

DISCUSSIONS (CONT’D)

16:00 • What the link between leak rate and sterility of the freeze-dryer

• How to implement and use PAT tools such as NIR, Pirani/MKS

17:00 End of IG Meeting


Welcome to the PDA Europe3rd Annual Meeting Conference Agenda


CONFERENCE AGENDA

19 Jun 2018

Tuesday, 26 June 2018

9:00 Welcome & Opening RemarksIntroduction & PDA Appreciation Awards


Jette Christensen, Chair, Novo Nordisk

Borke Van Belle, Chair, Janssen J&J

Keynotes: Pharmaceutical Industry Highlights - Past, Present, Future

Moderator: Borke Van Belle, Chair, Janssen J&J

The Pharmaceutical Industry is evolving quickly. The model is quickly shifting from generating blockbusters for disease treatment to targeted solutions that improve individual outcomes, prevention, chronic diseases, and identify new opportunities. The landscape in which we operate also needs to take into consideration the changing expectations of patients, healthcare professionals, payers and regulators. This session zooms in and highlights some of these aspects.

9:30 Future Opportunities and Directions for Pharmaceutical Manufacturing – A Global View

Axel Glatz, Pfizer

10:00 Reducing Complexity in Pharma Marc Philipp & Markus Hayek, Accenture

10:30 The Patient’s Perspective:Past, Present & Future of Diagnosis and Therapy

Jette Christensen, Patient

11:00 Coffee Break, Poster Session & Exhibition

Session 1 Regulatory Updates Moderator: Jette Christensen, Novo Nordisk

In this session, you will hear regulatory and industry perspectives on current regulatory hot topics.

11:30 Ongoing Activities at EMA Roberto Conocchia, European Medicines Agency

12:00 PDA Task Force Annex 1 Revision: Industry Comments Hal Baseman, ValSource

12:30 Activity Update on PUPSIT Maik Jornitz, G-CON Manufacturing

13:00 Q&A, Discussion

13:30 Lunch Break, Poster Session & Exhibition

TR ANSITION TO PAR ALLEL TR ACKS


CONFERENCE AGENDA

Session 2 TRACK A TRACK B

Big Data Managing Manufacturing

Moderator: Ulrike Malordy, PQE Moderator: Borke Van Belle, Janssen J&J

Industry 4.0 is changing the industrial landscape in general and the pharmaceutical industry is no exception. Based on compliant processes for Data Integrity, pharma companies now have the opportunity to improve processes with the help of real time process data and thereby reach data based decisions. This promises an improvement in the quality of processes and push process efficiency.

Pharmaceutical manufacturing is undergoingsignificant changes: batch sizes decrease, flexibilityincreases, personalized medicines and serializationhave entered the manufacturing units, anddigitalization is making leap progress. This sessionhelps provide insight in these ever-increasingdemands, and in the opportunities they bring.

14:30 Big Data Integrity: How to Succeed in the Challenge Using the Cloud

Toni Manzano, Bigfinite

Enabling Agile Digitalization towards Industry / Pharma 4.0

Rene Zoelfl, Parametric Technology GmbH (PTC)

14:55 Managing the Digital Transformation

Sebastian Schmitz, Industry 4.0 Maturity Center

Process, Product, Patient – Advanced Process Control in Manufacturing

Olav Lyngberg, Janssen J&J

15:20 What’s in Your Data? PDA Tackles Insights at the Shop Floor

Aaron Goerke, Roche

A Continuous Improvement Metric for Bio-Pharmaceutical Manufacturing

Ajay Babu Pazhayattil, Apotex


PAR ALLEL TR ACKS


New Era of Manufacturing Technology Digital Health & Precision MedicinePatient Centricity

Moderator: Yves Mayeresse, GSK Moderator: Chris Procyshyn, VanRX

Engineering should evolve at the same pace as other part of the pharmaceutical industry. Technology improvement is there to create value for the companies. Today few trends appear to predict future factory. One of them it’s to go from big to small size in order to address more specific need, this point will be highlighted through a case study on factory of the future. Another trend is human versus robot use. In one presentation, the automation of human task will be presented with software Robotic Process Automation. In a second part, a rigorous technology management approach from Ideation, Feasibility Testing, Pilot and Full implementation that requires culture and strong processes will be explained.

The combination of today’s advances in microprocessing power and genomic data are enabling completely new models for diagnosing and managing the delivery of therapeutic needs. While our digital lives are constantly adding and adapting to new technologies, the applications of these similar techniques and capabilities offers new challenges and opportunities for drug delivery. This session will focus on examples of these applications, along with the challenges and considerations necessary to make the potential advances become reality.

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CONFERENCE AGENDA

pda.org/EU/Annual2018

16:15 Targeted Innovation Management &Examples in Fill & Finish

Timo Simmen, Janssen J&J

Introducing a New Age of User-Centricity - Applying Eye-tracking to the Development of New Combination Products

Andreas Schneider, Ypsomed

16:45 Robotic Process Automation (RPA)

Frederik Strecker Kruse, Novo Nordisk

Why Better Human Understanding is the Only Future

Craig Scott, Greensand

17:15 Factories of the Future to Factories of the Here and Now – New Generation Biologics

Indu Conley, DPS Global

Empowering Chronotherapy through Connected Devices and Digital Technologies

Agnes Fritsch, Altran

17:45 Q&A, Discussion Q&A, Discussion

18:00 End of Day 1 & Networking Event


CONFERENCE AGENDA


Wednesday, 27 June 2018

PAR ALLEL TR ACKS


Smart Industry Regulatory Perspectives

Moderator: Toni Manzano, Bigfinite Moderator: Barbara Allen, Eli Lilly

The 4th Industrial Revolution was publicly announced in 2011 at the Hannover Fair1. Since then, elements such as the Digital Twins, Industrial Internet of Things or Cyber Physical Systems have come into the scene as unseparated elements, providing the necessary ingredients for a paradigm shift in many manufacturing areas. Over all these components, the most pioneering are related with the predictive analytics and artificial intelligence, directly applied to real use cases without resolution just a few years ago. How is the Pharma industry adopting this challenge?

The regulatory environment continues to evolve. Participants will receive updates on key hot topics, hear about PDA initiatives and have the opportunity to seek and share challenges and ideas.

9:00 The Smart Industry, A Reality Affordable with Courage

Kasper Malte Larsen, Novo Nordisk

ICH Q12 and Post Approval Change: PDA Innovation for Availability of Medicines (PAC iAM)

Ursula Busse, Novartis & Emma Ramnarine, Genentech

9:30 The Digital Robot Pharma Factory

Martin Dueblin, One One Eleven

Knowledge as an Asset: Accelerating Knowledge Availability Across the Lifecycle

Paige Kane, Dublin Institute of Technology / MSD

10:00 Smart Packaging as an Enabler for an Outcome Based Healthcare System

Stefan Wiedemann, Schreiner MediPharm

Assessing and Improving Quality Culture: Tools and Resources

Susan Schniepp, Regulatory Compliance Associates

10:30 Q&A, Discussion Q&A, Discussion



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CONFERENCE AGENDA

pda.org/EU/Annual2018

PAR ALLEL TR ACKS


Young Professionals in PDA Data Integrity

Moderator: Jette Christensen, Novo Nordisk Moderator: Aidan Harrington, DPS Group

PDA is focusing on diversity and we are welcoming young professionals to present. This session does not require a special topic to be presented; instead young professionals will share with us what they are working with and which are of interest for most of us.

The Data Integrity presentations dealing with audit trail review, the human element and governance across corporate networks represent three of the most relevant DI topics that impact the industry today. While these DI topics are well-known, the challenge for the industry is to be aligned in its response. Each presentation presents solutions and proposals to ensure that data can be trusted. These will help align attendees and the industry in its responses to the specific scenarios identified.

11:15-11:30

Protein Powder Suspensions in Non-Aqueous Vehicles – A Potential Alternative to Conventional Formulations?

Christoph Marschall, Ludwig-Maximilians-University

11:15-11:45

Data Integrity: Eliminating Risk & Human Error in Our Manufacturing and Laboratory Processes

Matthew Paquette, Charles River

11:30-11:45

Establishing Communities of Practice for Effective Knowledge Management in the Pharmaceutical Industry

Rita Ruth Hampe, Novartis

11:45-12:15

Data Integrity Governance & Metrics to Mitigate Regulatory Risks Across Corporate Networks

Danilo Neri, PQE

11:45-12:00

Continued Process Verification: A Maturity Model for Industry

Gavin Kinsella, Amgen

12:15-12:45

Industry Coalition – Position Paper concerning Audit Trail Review

Christian Scheidl, Novartis

12:00-12:15

Holistic Approach to System and User Dependencies

Sofie Rytter, Novo Nordisk

12:45-13:00

Q&A, Discussion

12:15-13:00

Q&A, Discussion

13:00 Lunch Break, Poster Session & Exhibition


CONFERENCE AGENDA

Closing Plenary Moderator: Yves Mayeresse, GSK Vaccines

14:00 Advanced Manufacturing Technology Andrew Rutter, GSK

14:30 Future Challenges and Opportunities for ManufacturingSite Operations

Cristiano Demolli, Eli Lilly


15:30 Healthcare of the Future: Multi Organ Chip Technologies Reyk Horland, TissUse

16:00 Panel Discussion, Q & A

16:30 Summary, ConclusionsClosing RemarksEnd of Conference & Farewell

Jette Christensen, Novo Nordisk

Borke Van Belle, Janssen J&J


PharmaceuticalMicrobiology


Simulcast Conference

15-16 October 2018Marriott Hotel

Berlin | Germany

Register by 26 August 2018

and SAVE!


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TO E XHIB ITPDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and biopharmaceutical industry. Exhibition and Sponsorship Opportunities are avail-able. A basic exhibition package for this event is priced 1.895 Euro net (table-top). For more information please contact [email protected]



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Training & Education Program

PDA Education offers courses that are developed and

taught by experts. They are uniquely targeted to professionals involved in the development and manufacturing of quality pharmaceutical and biopharmaceutical products.

Facts that Make a DifferenceUp-to date training courses and workshops taught by internatio-nally renowned experts

Customized in-house training courses and workshops available

Wide range of training courses with hands-on experience to drive expertise, awareness, and innovation

europe.pda.org

http://europe.pda.org

PDA Education Program

28-29 June 2018Practical Approach to Quality CultureTwo-Day Training Course

28-29 June 2018Best Compliance Practice in a GMP Regulated Testing LaboratoryTwo-Day Training Course

28-29 June 2018Test-Methods forPre-filled Syringe SystemsTwo-Day Training Course


TWO-DAY TRAINING COURSE

Who Should Attend Functions:

• Middle Management• Managers with employee responsibility• Group Leaders• Department Heads• Directors• Executive Level

Departments:

• Quality Assurance• Quality Control• Production• Purchasing• Regulatory Affairs• R&D• Human Resources• Controlling

Learning Objectives This training course is interactive, hands-on, and will empower you to measure, develop and improve the quality culture of your company:

• Learn to measure quality attributes and quality behaviors• Identify weaknesses and deficits in quality behavior• Investigate root causes and define effective CAPAs for improvement• Optimize your measures with respect to cost, time and quality

Thomas Krieger, PhD, KU-Pharma Consulting

Thomas Krieger is founder and CEO of Krieger Unternehmensberatung - Pharma (KU-Pharma) since 2009. KU-Pharma is providing quality consulting in quality assurance, in value-based Quality Culture and support as a Qualified Person for the pharmaceutical industry. After the Ph.D. in Pharmacy, Thomas graduated as specialized pharmacist of Pharmaceutical Analysis. For 25 years he holds the legal qualification and has professional experience as a Qualified Person pursuant to Directive 2001/83/EC. For 20 years Thomas Krieger has held different legal functions according to the drug law and various senior management and leadership positions in quality control, quality assurance, regulatory affairs and scientific departments. He worked for several pharmaceutical companies, from Global Players

with more than 50,000 employees to private owned companies with less than 100 employees.

Martin Haerer, Senior Director R&D/Qualified Person, Holopack Verpackungstechnik GmbH

After the Ph.D. in Pharmacy, Martin started his career at Holopack Verpackungstechnik in 1990. In the following years, he managed different projects in Production, Quality Control and Quality Assurance to improve the Quality System and Production. In 2006 he was appointed Production Manager and Qualified Person. Currently he is responsible for Business Development, Technology Transfer and Research, and still acting as Qualified Person with QA responsibilities. Martin was voted Member of the Board of the BFS-IOA Association as Regulatory Officer. He is member of the German QP Association and Board Member of Federal German Pharmacist Advanced Training Organisation (BAK).

Faculty

Overview

A good quality culture is established when all employees starting from CEO to shop floor workers are accountable for quality.The following attributes are important indicators for quality culture: management communication emphasizing that quality is everyone’s responsibility, established quality improvement objectives, quality topics included in relevant meetings, and an implemented error prevention process. These quality attributes are related to management responsibility and are elements of the continuous improvement of the pharmaceutical quality system as mentioned in the ICH Q10 guideline. Quality culture is a key management element for success. However, quality culture does not establish itself but requires empowerment, commu-nication and daily quality awareness.

Practical Approach toQuality Culture



TRAINING COURSE AGENDA

Thursday, 28 June 2018 9:00 – 17:45

9:00 Welcome & Introduction

9:30 Lecture 1: What does Quality mean?

10:15 Lecture 2: Quality Behaviors

10:45 Coffee Break

11:15 Interactive Session 1: Bad and Good Behaviors

11:45 Interactive Session 2: Assessment Exercise

12:15 Lunch Break

13:15 Lecture 3: Investigation Principles

14:00 Interactive Session 3: Root Cause Investigation Exercise

14:45 Coffee Break

15:15 Interactive Session 3: Root Cause Investigation Exercise (continued)

17:00 Lecture 4: Correction, CAPAs, Effectiveness Check

17:30 Recap of Day 1, Forecast to Day 2

17:45 End of Day 1

Friday, 29 June 2018 9:00 – 16:30

9:00 Recap of Day 1, Forecast of Day 2

9:15 Lecture 5: Toolbox for Improvement of Quality Behaviors

10:00 Interactive Session 4: Toolbox Assessment

10:30 Interactive Session 5: Improvement of Quality Behaviors

11:00 Coffee Break

11:30 Interactive Session 5: Improvement of Quality Behaviors (continued)

12:00 Lecture 6: Cost-Time-Quality-Dilemma

12:30 Interactive Session 6: Optimized Quality Culture

13:00 Lunch Break

14:00 Interactive Session 6: Optimized Quality Culture (continued)

14:30 Lecture 7: Next steps for Improvement

15:20 Break

15:30 Exchange of experience with improvement of Quality Culture

16:00 Summary and Conclusion

16:15 Questions & Answers

16:30 End of Course




Who Should Attend The course should be attended by operators and supervisors in quality control laboratories of the pharmaceutical industry which are faced with the challenge to implement those, sometimes complex cGMP regulations into their daily business in an efficient and effective manner.

• Laboratory personal• Head of quality control laboratories• Supervisors• Quality Assurance personal focusing on quality control topics,

for example quality-on-the-floor personal

Learning Objectives

• Understanding how the most important cGMP requirements can be implemented in the quality control laboratory• Development of approaches regarding the implementation of cGMP compliance within the quality control laboratory considering

German and international regulations• Competence regarding the implementation of data integrity compliance in the quality control laboratory, for example “audit trail

review”.• Self-contained management of OOS-results• Development of sampling protocols using statistical tools• Implementation of training programs in quality control laboratories

Dirk Feldmann, PhD, Head of Quality Operations, QP, Bausch & Lomb, Berlin

Dirk Feldmann studied Pharmacy at the FU Berlin and finished his PhD thesis in Food Chemistry at the TU Berlin. In 1996 he became the laboratory head of several analytical laboratories of the German military forces in Berlin. Since 2006, he has held various positions at Bausch & Lomb, Berlin (Head of laboratory for bulk, finished goods and stability control and deputy head of QC, Head of Quality Assurance, Qualified Person, Head of Manufacturing). Currently Dirk Feldmann holds the position of Head of Quality Operations/Batch Release and QP at Bausch & Lomb, Berlin. Furthermore, between 2010 and 2012 he held the position of a pharmacist at Saint Luke Foundation / Kilimanjaro School of Pharmacy in Moshi, Tanzania as part of his work in an international development aid project.

Klaus von Jan, PhD, CRS Compliance & Regulatory Services

After his studies of chemistry at the TU Stuttgart and his PhD in Organic Chemistry about the synthesis and characterization of the structure of Oligonucleotides, Klaus von Jan joined Millipore BioSyntech GmbH, Hamburg, as Head of Quality Control and Quality Assurance in 1988. In 1995 he joined Chiron Vaccines Germany in Marburg as Director Quality Assurance Bulk Manufacturing Germany. Since 2006, Klaus von Jan is an independent consultant in the pharmaceutical industry focusing on aseptic manufacturing, vaccines and biologics, quality control, computer system validation, data management, FDA inspections and interims management. He has been the co-founder of Compliance Systems GmbH in 2006 as well as co-founder and co-owner of the Swiss-based pmc-support GmbH.

Faculty

Overview

This course provides detailed understanding regarding the implementation of respective cGMP requirements in a state-of-the-art quality control laboratory in a pharmaceutical company. The course does not just provide an overview about the most important cGMP regulations (OOS management, sample management, method validation, training, documentation, data management). In extensive workshops those regulations are further explained and extensively discussed within the group and solutions for the implementation are developed. Those results are further discussed with the trainers and with all attendees. This approach will not only provide the respective knowledge but also the ability to implement those solutions in the laboratory of the attendees.

Best Compliance Practice in a GMP Regulated Testing Laboratory




Thursday, 28 June 2018 9:00 – 17:00

9:00 Welcome & Introduction

9:45 cGMP-Requirements in the Quality Control Laboratory - A Short Overview• OOS-management, aborted tests• Method Validation / Method Verification• Sample Management• Sampling• Data Management• Documentation• Training

10:45 Coffee Break

11:15 Case Study 1 / Workshop: OOS-Management, Practical Example• Case explanation• Expectation of the teamwork• Presentation of results• Best Practice discussion

12:30 Lunch Break

13:30 The QP in the Quality Control Laboratory• Typical issues / failures in the daily business• Failure during sampling• Development of sampling protocols• Statistical tools for determination of sample

size

15:00 Coffee Break

15:30 Case Study 2 / Workshop:• Development of a sampling protocol and

determination of the sample size based on the presented methods

• Presentation of results and Best Practice discussion

17:00 End of Day 1

Friday, 29 June 2018 9:00 – 16:30

09:00 Recap Day 1, Open Questions

9:30 Introduction to Data Management• 21 CFR Part 11, Annex 11• Expectations of authorities (MHRA, FDA)• Data integrity• Batch related audit trail review• Documentation and data security

10:45 Coffee Break

11:30 Case Study 3 / Workshop• Management of an FDA 483 observation

regarding data integrity• Implementation and documentation of a

batch related audit trail review• Presentation of results and Best Practice

discussion

12:30 Lunch Break

13:30 Case Study 4 / Workshop• Method Validation / Method Specification• Development of an activity protocol for the

relocation of a sterility laboratory• Presentation of results and Best Practice

discussion

14:30 Coffee Break

15:00 Case Study 5 / Workshop: Development of a Training Program for a Quality Control Laboratory• How can you organize a wide range of train-

ings in an efficient and effective manner• Success controls• Development of a training program

16:00 Summary, Open Questions, Feedback

16:30 End of Training Course




Who Should Attend The course is designed specifically for those who are involved or interested in the development, manufacturing and QC-testing of a Pre-filled Syringe System

• Engineers and Managers in Device Development and all other technical functions surrounding syringe systems

• Quality Personal / Regulatory Personal• Clinical and commercial Drug Product Manufacturing

Learning Objectives

Upon completion of the course the participants will have solid knowledge of

• Materials used for PFS Systems• Luer Cone and Luer Lock Compliance Testing• Requirements for the empty sterile sub-assembled syringe ready for filling• Test Methods for Drug Product Filled Syringes• PFS used in Delivery Systems

Horst Koller, CEO, HK Packaging Consulting

Prior to becoming a consultant, Horst worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years industry experience. His consulting company is focusing on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active speaker on international conferences. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.

Roman Mathaes, PhD, Senior Group Leader, Lonza Drug Product Services

Roman is leading the Lonza particle lab and the container closure integrity testing. In this role, he is responsible for container closure integrity testing of vials and Pre-filled syringes and process development of capping / crimping. Prior to this assignment, Roman was working within Roche / Genentech network supporting process development of the commercial manufacturing vial capping process. Roman is a pharmacist by training and conducted his studies at the University of Marburg and King’s College London. He holds a PhD in Pharmaceutical Technology from the University of Munich for work on subvisible particle characterization.

Faculty

Overview

The course will be an interactive lecture around Pre-filled Syringe Systems including ISO compliance testing. The participants will benefit from first hand information of both lecture leaders based on practical experience. The lecture includes the life cycle of a PFS from the idea to finished marketed product.

Test-Methods forPre-filled Syringe Systems




Thursday, 28 June 2018 9:00 – 17:45

9:00 Welcome

9:15 Introduction to Syringe Systems and Components

10.30 Coffee Break

11:00 Regulatory Requirements of Finished Pre-filled Syringes – Part 1• System Characterization / Physical

Characterization

12:30 Lunch Break

13:30 Regulatory Requirements of Finished Pre-filled Syringes – Part 2• Pharmaceutical Characterization

15:30 Coffee Break

16:00 Luer cone and Luer lock Compliance Testing for Glass and Polymer Syringes

17:30 Wrap-up of Day 1

17:45 End of Day 1

Friday, 29 June 2018 9:00 – 15:30

9:00 Requirements for the Empty Sterile Sub-assem-bled Syringes Ready for Filling- Part 1• Cone Breakage / Flange Breakage / Leakage

10:15 Coffee Break

10:45 Requirements for the Empty Sterile Sub-assem-bled Syringes Ready for Filling- Part 1 (cont.)• Cone Breakage / Flange Breakage / Closure

Testing

11:45 Requirements for the Empty Sterile Sub-assem-bled Syringes Ready for Filling- Part 2• Break Loose and Gliding Force / Needle Testing /

Particulate Matter

13:15 Lunch Break

14:15 Additional Testing for Use in Delivery Devices

15:15 Wrap-up of Day 2

15:30 End of Training Course


V E N U EBerlin Marriott HotelInge-Beisheim-Platz 110785 BerlinGermanyTel: +49 30 22 00 00https://goo.gl/NaDEp5

CO NTAC T I N FO R M ATI O NConference InquiriesMelanie DeckerDirector Events & [email protected]

Conference Program InquiriesSylvia [email protected]

Registration Customer CareTel: +49 30 436 55 [email protected]

Education Program InquiriesElke von [email protected]

Exhibition / Sponsorship Inquiries Nadjeschda [email protected]

G E N E R A L A D D R E S SPDA Europe gGmbHAm Borsigturm 6013507 Berlin, GermanyTel: +49 30 436 55 08-0Fax: +49 30 436 55 08-66

TO E X H I B ITExhibition and Sponsorship Opportunities are available. PDA meetings and conferences are a great opportunity for your company to gain on-site exposure in front of high-ly-qualified, upper-level professionals in the pharmaceuti-cal and biopharmaceutical industry. Exhibit at PDA events and let your company’s products or services become a valuable tool or resource for our attendees.

S PEC I A L R EQU I R E M E NT SIf you require special accommodations to fully par- ticipate, please attach a written description of your

needs with your registration form. Specific questions can be directed to [email protected].


Special offer: Discounted travel with Lufthansa Group Airlines

Lufthansa Group Par tner Airlines of fer a comprehensive global route network linking major cities around the world. We offer spe-cial prices and conditions to par ticipants, visitors, exhibitors, in-vited guests as well as employees of the Contracting par tner and their travel companions. To make a reser vation, please click on www.lh.com/event-flight-booking and enter the access code DEZJESE in the "Access to Your Special Lufthansa Offer" area. This will open an online booking platform that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.

NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.

These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by send-ing an email to [email protected] and providing the access code as a reference.

D I R EC TI O N S

INFORMATION

BERLIN MARRIOTT HOTELBERLIN

© Google For directions click on the picture, scan the QR-code or go to https://goo.gl/maps/gsiyxs439oz

https://goo.gl/maps/gsiyxs439oz

https://goo.gl/maps/gsiyxs439oz

11th Workshop on Monoclonal Antibodies

PDA Europe Workshop, Exhibition, Education


27-28 November 2018Seville | Spain

Applications of Prior Knowledge to Monoclonal Antibody Discovery, Development and Commercialization

pda.org/EU/EAnnual201830

3rd PDA Europe Annual Meeting

Your registration is only complete upon filling in and submitting both pages of this form.

1 Registration

Please mark here if your company is an exhibitor to this event and you will receive the conference ticket at the special price of 1095 Euro per ticket. No further discounts are applicable with this option (as PDA Membership Discount or Group Ticket discount).

Discount for Exhibiting Companies

Group Registration Discount Register 5 colleagues for the conference at the same time and receive the 5th registration free. For more information on group discounts please contact Antje Petzholdt at [email protected]. Other discounts cannot be applied..

The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Europe has secured a limited number of rooms at a special group rate.

Book by 13 May 2018 to receive € 200* off the conference fee only EARLY BIRD DISCOUNT

26-27 June Conference only Conference Fee

3rd PDA Europe Annual Meeting PDA Member 16951 Nonmember 1995

2 Young Professionals 350* Early Bird 750 € 1 Regulatory/Academic 850

Poster Presenter please mark here (written approval required, conference fee applies)

28-29 June Two-Day Training Course Training Course Fee

Practical Approach to Quality Culture All Participants 1495


Test-Methods for Pre-filled Syringe Systems All Participants 1495


Best Compliance Practices at the GMP Testing Laboratory All Participants 1495

25 June Interest Group Meeting IG Meeting Fee

Quality Systems All Participants 300

25 June Interest Group Meeting IG Meeting Fee

Freeze Drying Technology All Participants 300

Reg Form Page 1

26-27 June 2018 | Berlin | Germany

1 Registration fee includes a one-year PDA membership if no further special discount is granted. If you do not wish to join PDA and receive the benefits of membership, please check here (same rate applies).

2 Rate applicable to all professionals under 35 years of age. A proof via ID or Passport copy is required, please submit this via fax or e-mail. Rate does not include membership. Further discounts as of Early Bird and Group Discount are not applicable to this rate.

This PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.


http://www.pda.org/Membership

pda.org/EU/Annual2018 31

Date Mandatory Signature

Your registration is only complete upon filling in and submitting both pages of this form.

3 Payment Options

Billing Address: Same as contact information address above. If not, please send your billing address to: [email protected]

By Bank Transfer Beneficiary: PDA Europe gGmbHIBAN: DE73 1007 0024 0922 8735 00 BIC (SWIFT-Code): DEUTDEDBBERBank Address: Deutsche Bank, Welfenallee 3-7, D-13465 Berlin, Germany

By Credit Card

American Express MasterCard VISA

For your credit card information safety:Please send your details by fax only.

Purchase Order

Purchase Order Number

Job Title *

Mailing Address

Substituting for(Ch e ck only i f you are subs t i tut ing for a pre v iously e nrolle d colleag ue; a nonme mb e r subs t i tut ing for me mb e r mus t pay t h e me mb e r ship fe e.)

* This information will be published in the conference attendee list. Should you not wish us to publish these details, please contact us.

1 Your Contact Information

PDA MemberName (Last, First, MI) *

ID Number

Country Email *

FaxBusiness Phone

Company* Department

City Postal Code

If this form is an update to a previously submitted form, please check here.

Mr. Ms. Dr. NonmemberI want to become a PDA Member. Please send me a subsription form

• All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.

• All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for sub-mitting documents by courier.)

• Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).

2 Information about Visa Matters

CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. A letter of confirmation will be sent to you within one week once payment has been received. You must have this written confirmation to be considered enrolled for this PDA event. PDA Europe reserves the right to deny access to anyone unable to provide written confirmation that all dues have been fully settled. SUBSTITUTIONS: If you are unable to attend, substitutions are welcome and can be made at any time, including on site at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until 2 weeks prior to the start of the event. After this two-weeks period, there will be a charge of € 100 per name change. REFUNDS: Refund requests must be sent to PDA Europe. If your written request is received on or before 13 May 2018, you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA Europe works PCI-Compliant. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled, 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. For more details, contact PDA at [email protected] or fax to +49 30 4365508-66. DOCUMENTATION: With your signature you give complete picture usage right to PDA and allow to film your exhibition space and intervention in the event, including the recording of your presentation for video purposes (with your slides, voice and image). This right extends also to the use of the resulting images in film documentation for webinars and similar items produced by PDA.

PDA Europe VAT I.D.: DE254459362Your Company VAT I.D.:

This number starts by your country code with two characters (example: PDA Europe’s country code starts with: DE | followed by the number)

3 WAYS TO REGISTER

ONLINE: pda.org/EU/Annual2018 FAX: +49 30 4365508-66EMAIL: [email protected]

123

Reg Form Page 2 3rd PDA Europe Annual Meeting

26-27 June 2018 | Berlin | GermanyThis PDF-file provides an automatic fill-in function. Your signature, however, is needed in writing.



www.europe.pda.org

General InformationPDA Europe gGmbHAm Borsigturm 60 13507 Berlin, GermanyTel: +49 30 4365508-0Fax: +49 30 4365508-66

Conference InformationMelanie DeckerDirector Events & ExhibitionsTel: + 49 30 [email protected]

Training Course InformationElke von LaufenbergManager Training & EducationTel: + 49 30 [email protected]

Events with additional Education Program. More information – http://t1p.de/7p9z

2 0 1 8 P D A E U R O P E E V E N T S

25 June25 June26-27 June

Interest Group Meeting Quality SystemsInterest Group Meeting Freeze Drying3rd PDA Europe Annual Meeting

IGIG

Berlin, Germany

15-16 October Pharmaceutical Microbiology Berlin, Germany

23-24 October Visual Inspection Forum Berlin, Germany

6-7 November Outsourcing & Supply Chain - A 360° View Seville, Spain

22 November Project Management in the Pharmaceutical Industry – Challenges & Possibilities

Berlin, Germany

27-28 November Pharmaceutical Freeze Drying Technology Seville, Spain

27-28 November 11th Workshop on Monoclonal Antibodies Seville, Spain

2 0 1 9 P D A E U R O P E E V E N T S

19-20 March Parenteral Packaging Venice, Italy

Subject to change For latest info: europe.pda.org Shortlist 19 Jun 2018

https://europe.pda.org

the parenteral drug association presents: 3 rd pda europe … · terumo 2 brevetti angela 4 altran...

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