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2022 PDA Annex 1 Workshop

2022 PDA Annex 1 Workshop (Amsterdam)

Sep 22 - Sep 23, 2022
Amsterdam, The Netherlands

  • Conference
  • Workshop
  • Europe

Overview

PDA will host a series of workshops to educate and help the industry implement the new 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 as a whole.

The intent of the workshops is to highlight specific sections with critical changes and include interactive sessions to provide attendees with clear understanding of and means to implement the requirements of the new Annex 1, in order to address the regulatory expectations. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry.

The workshops will be two days in length, 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. While the goal is to conduct these as in-person events to provide the greatest engagement, based on global circumstances where in-person events are not possible, a virtual platform will be used.


SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • Hal Baseman, Valsource, Chair
  • Gabriele Gori, GSK, Chair
  • Fred Ayers, Eli Lilly and Company
  • Amanda Bishop McFarland, Valsource
  • Biswarup DasGupta, Sarepta Therapeutics
  • Richard Denk, Skan
  • Cheryl Essex, Sanofi
  • Marc Glogovsky, Valsource
  • David Keen, Company for Individuals
  • Tracy Moore, MHRA
  • Patrick Nieuwenhuizen, PharmaLex
  • Don Singer, EcoLab
  • Neal Zupec, Baxter

Agenda

  • Day 1
  • Day 2
  • Thursday, 22 September

    09:00 – 09:15 | Welcome and Introduction

    09:15 – 10:50 | Session 1: Overview of and Revision Process for Annex 1

    09:15 | Regulatory Perspective

    09:50 | Industry Perspective

    10:15 | Q&A

    10:50 – 11:20 | Break

    11:20 – 13:00 | Session 2: Principles and PQS

    11:20 | Using Quality Risk Management to Enable the Contamination Control Strategy

    11:40 | Contamination Control Strategy Development

    12:00 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products

    13:00 – 14:00 | Lunch Break and Exhibition

    14:00 – 15:55 | Session 3: Premises, and Barrier Systems

    14:00 | Cleanroom Design: Classification, Qualification, Air Visualization

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

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

    15:00 | Q&A

    15:55 – 16:25 | Break

    16:25 – 17:45 | Session 4: Equipment, Technology, and Utilities

    16:25 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces

    16:50 | Water Systems and Other Critical Utilities

    17:45 | Q&A

  • Friday, 23 September

    09:00 – 09:15 | Day 1 Recap

    09:10 – 10:50 | Session 5: Personnel: Training, Qualification, Gowning, and Monitoring/Assessment

    09:10 | Qualification and Training

    09:35 | Gowning and Personnel Monitoring

    10:05 | Q&A

    10:50 – 11:20 | Break

    11:20 – 13:00 | Session 6: Production Technologies Part 1

    11:20 | Aseptic Processing

    12:00 | Filtration and Pre-use Post Sterilization Integrity Testing

    12:40 | Q&A

    13:00 – 14:00 | Lunch Break and Exhibit

    14:00 – 15:40 | Session 7: Production Technologies Part 2

    14:00 | Container Closure Integrity Testing and Finishing

    14:35 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)

    15:00 | Q&A

    15:40 – 16:10 | Break

    16:10 – 17:35 | Session 8: Aseptic Process Simulation/Environmental Monitoring

    16:10 | Environmental and Process Monitoring

    16:35 | Aseptic Process Simulations

    17:35 | Q&A and Final Panel Discussion

    18:00 | Workshop Ends

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
  • Who Should Attend

    Who Should 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

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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.


Amsterdam, The Netherlands

How to Get Here

By Air

More information coming soon.

By Car

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Other Options

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Directions

Registration Fees

Early Registration
Registration Type Price by 24 July 2022
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €845
Young Professional (Member) €845
Regular Registration
Registration Type Price after 24 July 2022
Member €1.895
Non-member €2.195
Govern./Health Authority/Academic €945
Early Career Professional (Member) €945

* For this member type or discount, online registration is not available, please contact [email protected].

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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Tel: +1 (301) 656-5900 ext. 115
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