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2022 PDA Annex 1 Workshop

2022 PDA Annex 1 Workshop (Dallas)

Apr 07 - Apr 08, 2022
Dallas, TX

  • Workshop
  • The Americas

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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.

Agenda

  • Day 1
  • Day 2
  • Thursday, 07 April

    08:00 – 08:15 | Welcome and Introduction

    08:15 – 09:50 | Session 1: Overview of and Revision Process for Annex 1

    08:15 | Regulatory Perspective

    08:50 | Industry Perspective

    09:15 | Q&A

    09:50 – 10:20 | Break

    10:20 – 12:00 | Session 2: Principles and PQS

    10:20 | Using Quality Risk Management to Enable the Contamination Control Strategy

    10:40 | Contamination Control Strategy Development

    11:00 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products

    12:00 – 13:00 | Lunch Break and Exhibit

    13:00 – 14:55 | Session 3: Premises, and Barrier Systems

    13:00 | Cleanroom Design: Classification, Qualification, Air Visualization

    13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring

    13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination

    14:00 | Q&A

    14:55 – 15:25 | Break

    15:25 – 16:45 | Session 4: Equipment, Technology, and Utilities

    15:25 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces

    15:50 | Water Systems and Other Critical Utilities

    16:45 | Q&A

  • Friday, 08 April

    08:00 – 08:15 | Day 1 Recap

    08:10 – 09:50 | Session 5: Personnel: Training, Qualification, Gowning, and Monitoring/Assessment

    08:10 | Qualification and Training

    08:35 | Gowning and Personnel Monitoring

    09:05 | Q&A

    09:50 – 10:20 | Break

    10:20 – 12:00 | Session 6: Production Technologies Part 1

    10:20 | Aseptic Processing

    11:00 | Filtration and Pre-use Post Sterilization Integrity Testing

    11:40 | Q&A

    12:00 – 13:00 | Lunch Break and Exhibit

    13:00 – 14:40 | Session 7: Production Technologies Part 2

    13:00 | Container Closure Integrity Testing and Finishing

    13:35 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)

    14:00 | Q&A

    14:40 – 15:10 | Break

    15:10 – 16:35 | Session 8: Aseptic Process Simulation/Environmental Monitoring

    15:10 | Environmental and Process Monitoring

    15:35 | Aseptic Process Simulations

    16:35 | Q&A and Final Panel Discussion

    17:00 | 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.

Hyatt Regency Dallas

300 Reunion Boulevard
Dallas, TX
Phone: +1 (214) 651-1234

Make a Reservation
Hyatt Regency Dallas
  • Accommodations

    A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. The rate is $249 for single or double occupancy. Guestroom rates are subject to discounted resort fee ($20 per night) and State and Local taxes.

    Reservations must be secured by Friday March 4, 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

    To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. Be sure to tell the reservationist that you are with the PDA Meeting 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. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information.

  • Amenities

    Located downtown next to an iconic Dallas landmark Reunion Tower, Hyatt Regency Dallas is a gateway to the best of the city. Live, work and be yourself at our inviting, contemporary hotel near the Dallas Convention Center and within walking distance of many tourist attractions, including Dealey Plaza and the Historic West End. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs.

How to Get Here

By Air

Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. Alaska Airlines, Delta and Southwest service this airport. Taxi fares from DFW are approximately $45-50 one way, not including tip. Taxi fares from DAL are approximately $20-25 one way, not including tip. App based rides are available to/from the airport.

By Car

The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. Valet Parking, operated by PMSI, is available at hotel entrance. In and out privileges for hotel guests only. Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. In and out privileges for overnight guests only, operated by PMSI. Self Parking Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower $19 Radish Lot, 0–4 hours | $9 Radish Lot, 4–8 hours | $13 Radish Lot, 8-24 hours | $19 B-Lot, 0–4 | $7 B-Lot, 4–8 hours | $13 B-Lot, 8-24 hours | $19 Valet Parking Overnight Guests |$32 + tax 0–4 hours | $22 4–8 hours| $26 8–24 hours | $32

Other Options

Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Please call 214 653 1101 for train information. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. Please call 214 849 6831 for bus information. DART Light Rail Service: the hotel is conveniently connected to Union Station on the Red and Blue lines and is also a stop for TRE commuter rail to Fort Worth. Dallas Streetcar: This is a FREE service provided by DART that picks up at Union Station, connected to the hotel, and runs to the Bishop Arts District, one of Dallas' best areas for food, shops and galleries.

Directions

Registration Fees

Regular Price
Registration Type Early Registration After 06 February
Member $1,695 $2,195
Non-Member $1,995 $2,495
Govern./Health Authority/Academic (Member/Non-Member) $700 $700
Student (Member/Non-Member) $350 $350
Early Career Professional (Member Only) $1,095 $1,095

* 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
[email protected]

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