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2022 PDA Annex 1 Workshop

2022 PDA Annex 1 Workshop (Dublin)

May 18 - May 19, 2022
Dublin, Ireland

  • Conference
  • Workshop
  • Europe

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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
  • Janie Miller, PDA
  • Falk Klar, PDA
  • Stefanie Nebelin, Manager Programs & Events, PDA

Agenda

  • Day 1
  • Day 2
  • Wednesday, 18 May

    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

  • Thursday, 19 May

    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
  • 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

    Who Should Attend

    More information coming soon.

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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.

Crowne Plaza Dublin Airport

Northwood Park
Dublin, Ireland
Phone: +353 1 862 8888

Make a Reservation
Crowne Plaza Dublin Airport
  • Accommodations

    Crowne Plaza Dublin Airport
    Northwood Park
    Dublin 9
    Santry Demesne
    Ireland
    Tel: +353 1 862 8888

    Rate: Single Room € 150 per night*
    Rate: Double Room € 180 per night*

    * Rates are per room and night, including the following services and benefits free of charge:
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply

    Cut Off Date: Monday, March 28, 2022

    The PDA block of rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate. After the cut-off date, rooms will be available at the prevailing rate based on availability.

    To make reservations, individuals may call the Crowne Plaza Dublin Airport at Tel: +353 1 862 8888. Please make sure to tell the reservationist that you are with the PDA group attending the 2022 PDA Annex 1 Workshop to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees.

  • Amenities

    This 4-star deluxe hotel is a 5-minute drive from Dublin Airport, with a free shuttle to and from the airport. It has luxurious rooms, free internet, and good bus service to the center of the city.

How to Get Here

By Air

The Crowne Plaza Dublin Airport is 3 km away from Dublin International Airport

By Car

The Crowne Plaza Dublin Northwood is set in parkland, close to highways M1 and M50, and 15 minutes from central Dublin. At Crowne Plaza Dublin Airport, self-parking is available for a daily rate of 6 EUR.

Other Options

The nearest train station is Connolly Station

Directions

Registration Fees

Early Registration
Registration Type Price by 20 March 2022
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €845
Young Professional (Member) €845
Regular Registration
Registration Type Price after 20 March 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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Contact

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Training Course Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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