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2022 PDA Annex 1 Workshop

2022 PDA Annex 1 Workshop (Palm Springs)

Oct 20 - Oct 21, 2022
Palm Springs, CA

  • 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, 20 October

    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, 21 October

    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.

Renaissance Palm Springs Hotel

888 Tahquitz Canyon Way
Palm Springs, CA

Renaissance Palm Springs Hotel
  • Accommodations

    A block of rooms has been reserved for PDA meeting participants at the Renaissance Palm Spring Hotel. The room block will open in April 2022. Please check back here at that time.

  • Amenities

    Savor beauty inside and out when you stay at the Renaissance Palm Springs Hotel. Set against a backdrop of swaying palm trees and the majestic San Jacinto Mountains, our Coachella Valley hotel captures the essence of desert living. Find your oasis while lounging beside one of the area's largest outdoor pools or sipping a refreshing drink in one of our private cabanas. Slip into sweet dreams in rooms and suites redesigned to pamper and please with pillowtop mattresses and spa-inspired bathrooms. Whether you desire a soothing massage or rejuvenating facial during your getaway, allow Spa Del Sol to anticipate your desires. Celebrate the area while delighting in a meal at Date, our casual restaurant where the locally grown fruit graces the menu. Rocks offers a trendy bar setting to unwind after a day of exploring the Palm Springs Aerial Tramway, Palm Springs Art Museum and boutique shops along the city's main thoroughfare. Indulge in the ultimate relaxation at Renaissance Palm Springs Hotel.

How to Get Here

By Air

Palm Springs International Airport (PSP) is 1.5 miles from Hotel. Estimated Taxi Fare 7 USD (one way). Ontario International airport (ONT) is 70 miles from Hotel. Los Angeles International Airport (LAX) is 124 miles from Hotel. This Hotel does not offer shuttle service.

By Car

The Renaissance Palm Springs Hotel is located at 888 Tahquitz Canyon Way, Palm Springs, CA 92262 USA. On-site Parking is 35 USD daily.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Early Registration After 21 August
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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