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2022 PDA Annex 1 Workshop

2023 PDA Annex 1 Workshop (Antwerp)

Nov 09 - Nov 10, 2023
Antwerp, Belgium

  • Workshop
  • Europe
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Program Highlights

PDA is delighted to announce we will be hosting two workshops to educate and help the industry with the August 2023 implementation of the new EU GMP Annex 1 revision. PDA has and continues to be committed to developing scientifically sound, practical, technical information, and training programs to advance science and regulation for our members and the industry.

The intent of the workshops is to address the challenges and implications that have arisen with the implementation of the new EU GMP Annex 1. These workshops, scheduled for November and December, will focus on examining specific sections with critical changes and facilitating interactive sessions to provide attendees with a clear understanding of how to navigate and successfully meet the requirements of the revised EU GMP Annex 1. PDA has developed a standardized approach for workshop topics, ensuring that the information delivered to the industry remains consistent and relevant to the current regulatory landscape.

The workshops will be face-to-face, two days in length, and conducted globally (U.S. and EU). They will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers’ challenges and best practices.

POSTER PRESENTER

Submit your poster and get the chance to interacted with the audience.
Submission Deadline 22 September 2023!

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Overview

Dear Colleagues,

How is your firm managing on-going improvements and alignment with the approved EU GMP Annex 1?

EU GMP Annex 1 is arguably the most influential and important sterile product manufacturing guidance for our industry in the past 15 years and it will be so in the next 10 years. Therefore, PDA has designed this workshop to provide safe, interactive, and useful sessions for you and your peers to discuss the EU GMP Annex 1 and how your firms are meeting these new requirements.

We have selected topics, as expressed by you, that you find the most challenging and need more assistance with. Experts from regulators and industry will provide their insights via presentations, panel discussions, table discussions, and Q&A. This is a unique opportunity that will provide you with the insights needed to remove the guess work before your next inspection.

We welcome you to the 2023 PDA Annex 1 Workshop here in Antwerp and encourage you to actively participate and provide your own valuable insight into challenges you have, so that you will end the workshop with a clear direction to share within your own firms.

Looking forward to seeing you in Antwerp!

Sincerely,

The Co-Chairs


SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • Frederic Ayers, Eli Lilly, Co-Chair
  • Tracy Moore, TM Pharma Group, Co-Chair
  • Amanda Bishop McFarland, ValSource
  • Paolo Curto, D.O.C. Documentation Organization & Consultancy 
  • Richard Denk, SKAN
  • Derek Duncan, LIGHTHOUSE Instruments
  • Kurt Jaecques, GSK
  • David Keen, Ecolab
  • Patrizia Muscas, Eli Lilly
  • Falk Klar, PDA Europe
  • Sabine Hartmann, Manager Programs & Events, PDA Europe 
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Agenda

Download full Agenda
  • Day 1
  • Day 2

  • Thursday, 09 November 2023

    09:00 – 09:20 | Welcome and Introduction
    Falk Klar, PDA Europe
    Frederic B. Ayers, ValSource
    Tracy Moore, TM Pharma Group

    09:20 – 10:30 | P1: Overview of and Revision Process for Annex 1
    Frederic B. Ayers, ValSource
    Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. The revised Annex 1 contains a significant amount of new and more detailed content on many topics. It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes.

    09:20 | Regulatory Perspective
    Regulatory Speaker Invited

    09:40 | Insights from a Former Regulator
    Tracy Moore, TM Pharma Group 

    10:00 | Q&A & Panel Discussion 

    10:30 – 11:00 | Coffee Break, Poster Session & Exhibition 

    11:00 – 12:15 | P2: Scope, Principles, and Pharmaceutical Quality Systems
    Moderator: Frederic B. Ayers, ValSource
    This session opens our in-depth look at the content of the draft Annex 1. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. This session will also address the expanded scope of Annex 1 to include some non-sterile.

    11:00 | Using Quality Risk Management to Enable the Contamination Control Strategy
    Amanda Bishop McFarland, ValSource Inc.

    11:20 | Contamination Control Strategy Development
    Speaker Invited 

    11:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products
    Speaker Invited 

    12:00 | Q&A

    12:15 – 12:20 | Transition into Breakout Groups

    12:20 – 13:00 | Breakout Session 1
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems.

    13:00 – 14:00 | Lunch Break, Poster Session & Exhibition

    14:00 – 15:15 | P3: Premises and Barrier Systems
    Moderator: Patrizia Muscas, Eli Lilly and Company
    Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and Isolators. This session will look at some of the key design and operational aspects that have been impacted by the revised Annex 1.

    14:00 | Cleanroom Design: Classification, Qualification, Air Visualization
    Frederic B. Ayers, ValSource

    14:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring
    David Keen, Ecolab

    14:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination
    Richard Denk, SKAN 

    15:00 | Q&A

    15:15 – 15:20 | Transition into Breakout Groups

    15:20 – 16:00 | Breakout Session 2
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P3: Premises and Barrier Systems. 

    16:00 – 16:30 | Coffee Break, Poster Session & Exhibition

    16:30 – 17:45 | P4: Equipment, Technology, and Utilities 
    Moderator: Paolo Curto, D.O.C. Documentation Organization & Consultancy
    This session will discuss the impact of the Annex 1 revision on aseptic manufacturing facilities, specifically focusing on equipment design, indirect product contact parts, such as stopper bowls, and critical utilities, such as water systems.

    16:30 | Material Transfer
    Tracy Moore, TM Pharma Group

    16:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces 
    Richard Denk, SKAN 

    17:10 | Aseptic Process Simulations
    Patrizia Muscas, Eli Lilly and Company 

    17:30 | Q&A

    17:45 – 17:50 | Transition into Breakout Groups

    17:50 – 18:30 | Breakout Session 3
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P4: Equipment, Technology, and Utilities.

    18:30 – 20:00 | End of Workshop Day 1 & Networking Reception

  • Friday, 10 November 2023

    08:00 – 08:20 | Welcome and Day 1 Recap
    Moderator: Tracy Moore, TM Pharma Group

    08:20 – 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
    Moderator: Amanda M. McFarland, ValSource
    Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy.

    08:20 | Qualification and Training
    Speaker Invited 

    08:40 | Gowning and Personnel Monitoring 
    Frederic B. Ayers, ValSource

    09:00 | Q&A

    09:15 – 09:20 | Transition into Breakout Groups

    09:20 – 10:00 | Breakout Session 4
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment.

    10:00 – 10:30 | Coffee Break, Poster Session & Exhibition

    10:30 – 11:25 | P6: Production Technologies, Part 1
    Moderator: Amanda M. McFarland, ValSource
    This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success.

    10:30 | Aseptic Processing
    Frederic B. Ayers, ValSource

    10:50 | Filtration and Pre-use Post Sterilization Integrity Testing
    Speaker Invited 

    11:10 | Q&A

    11:25 – 11:30 | Transition into Breakout Groups

    11:30 – 12:10 | Breakout Session 5
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing).

    12:10 – 13:10 | Lunch Break, Poster Session & Exhibition

    13:10 – 14:05 | P7: Production Technologies, Part 2.
    Moderator: Tracy Moore, TM Pharma Group
    This session will introduce some of the more intriguing topics covered and expanded in the revised Annex 1, which were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions.

    13:10 | Container Closure Integrity Testing and Finishing
    Derek Duncan, Lighthouse Instruments

    13:30 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)
    Speaker Invited 

    13:50 | Q&A

    14:05 – 14:10 | Transition into Breakout Groups

    14:10 – 14:50 | Breakout Session 6
    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P7: Production Technologies, Part 2 (Container Closure Integrity Testing and Finishing and Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization).

    14:50 – 15:20 | Coffee Break, Poster Session & Exhibition 

    15:20 – 17:00 | P8: Environmental Monitoring and Contamination Control Strategy
    Moderator: Amanda M. McFarland, ValSource
    APS has been identified as one of the key aspects of aseptic process control and monitoring. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process.

    15:20 | Environmental and Process Monitoring
    Kurt Jaecques, GSK

    15:40 | Contamination Control Strategy Development
    Speaker Invited 

    16:00 | Q&A and Final Panel Discussion

    16:40 | Day 2 Report Out & Closing Remarks from Workshop Co-Chairs
    Frederic B. Ayers, ValSource
    Tracy Moore, TM Pharma Group

    16:55 | Closing Remarks & Farewell

    17:00 I End of Workshop

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this workshop, participants will be able to:

    1. Gain awareness of the requirements and changes in Annex 1 and move towards compliance with the proposed changes in the revision
    2. Develop strategies for implementation and verification of the Annex 1 requirements, respectively, for their organizations
  • Why Attend

    Why Attend

    Functional Areas
    • Quality Control (Analytical)
    • Quality Control (Microbiology)
    • Quality Systems
    • Quality Compliance
    • Engineering
    • Manufacturing
    • Quality Assurance Operations
    • Regulatory Affairs
    • Technical Operations
    • Training
    • Validation
    • Facilities
    • Packaging
  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.


Antwerp, Belgium

  • Accommodations

    PDA recommends the reservation at the following hotel

    Crowne Plaza Antwerp
    Gerard le Grellelaan 10
    2020 Antwerp
    Belgium

    Tel: +32 3 259 75 00

    PDA Europe has reserved a limited number of rooms by 05 October 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

  • Amenities

How to Get Here

By Air

There are two airports close by, Antwerp International Airport wich is around 20 min by car or Brussle International Airport (Airport Zaventem) which is an hour away. The hotel offers Airport shuttles, please contact the hotel for further information.

By Car

On site parting is available, please contact the hotel for further information.

Other Options

You can get their by train within 30 minutes from Antwerp international Airport.

Directions

Registration Fees

Early Registration
Registration Type Price by 10 September
Member €1.845
Non-member €2.145
Govern./Health Authority/Academic €870
Early Career Professional (Member) €870





Regular Registration
Registration Type Price after 10 September
Member €2.045
Non-member €2.345
Govern./Health Authority/Academic €970
Early Career Professional (Member) €970





Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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