2022 PDA Annex 1 Workshop (Palm Springs)

Name: 2022 PDA Annex 1 Workshop (Palm Springs)
Start: 2022-10-20
End: 2022-10-22

Oct 20 - Oct 21, 2022

Palm Springs, CA

Workshop

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Overview
Agenda
Additional Information
Travel
Registration Fees
Exhibit & Sponsorship
Related Events
Contact

Program Highlights

Agenda highlight: Select sessions will be followed by interactive breakout group discussions focused on implementation!

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.

Agenda

Day 1
Day 2

Thursday, 20 October

08:00 – 08:20 | Welcome and Introduction

08:20 – 09:30 | Session 1: Overview of and Revision Process for Annex 1

08:20 | Regulatory Perspective

08:40 | Industry Perspective

09:00 | Q&A

09:30 – 10:00 | Break

10:00 – 11:00 | Session 2: Principles and PQS

10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy

10:20 | Contamination Control Strategy Development

10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products

11:00 – 11:05 | Transition into Breakout Groups

11:05 – 12:00 | Breakout Session 1

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

13:00 – 14:00 | 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 – 14:05 | Transition into Breakout Groups

14:05 – 15:00 | Breakout Session 2

15:00 – 15:30 | Break

15:30 – 16:30 | Session 4: Equipment, Technology, and Utilities

15:30 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces

15:50 | Water Systems and Other Critical Utilities

16:10 | Q&A

16:30 – 16:35 | Transition into Breakout Groups

16:35 – 17:30 | Breakout Session 3

17:30 – 18:30 | Networking Reception

Friday, 21 October

08:00 – 08:20 | Day 1 Highlights

08:20 – 09:00 | Session 5: Personnel: Training, Qualification, Gowning, and Monitoring/Assessment

08:20 | Qualification and Training

08:40 | Gowning, Personnel Monitoring, and Beyond

09:00 – 09:05 | Transition into Breakout Groups

09:05 – 09:45 | Breakout Session 4

09:45 – 10:15 | Break

10:15 – 11:15 | Session 6: Production Technologies, Part 1

10:15 | Aseptic Processing

10:45 | Filtration and Pre-Use Post Sterilization Integrity Testing

11:15 – 11:20 | Transition into Breakout Groups

11:20 – 12:00 | Breakout Session 5

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

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

13:00 | Container Closure Integrity Testing and Finishing

13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)

13:40 – 13:45 | Transition into Breakout Groups

13:45 – 14:30 | Breakout Session 6

14:30 – 15:00 | Break

15:00 – 16:30 | Session 8: Aseptic Process Simulation/Environmental Monitoring

15:00 | Environmental and Process Monitoring

15:30 | Aseptic Process Simulations

16:00 | Q&A and Final Panel Discussion

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
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

Got a Question? We have answers

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
Phone: +1 (888) 236-2427

Make a Reservation

Accommodations

Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

A block of rooms have been reserved for meeting participants at the Renaissance Palm Springs Hotel. The group rate is $199 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, 23 September 2022. After this date, reservations can be made on a space-and-rate available basis only.

To make reservations, individuals may click on the reservation link above or call the Renaissance Palm Springs Hotel at +1 (888) 236-2427. 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 unless otherwise specified on your reservation information.
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).

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

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.

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].

All prices in Euro (EUR), excluding VAT

For your credit card information safety: Please send your details by fax only

For an easier registration, please note the helpful hints on the registration form

Ways to Register

Online Registration
FAX: +49 30 436 55 08 66
[email protected]

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
Please contact us if you are entiteld to receive a discount

Antje Petzholdt

Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

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Contact

Program Inquiries

Brooke Lustig, CMP

Senior Manager, Programs

Tel: +1 (301) 656-5900 ext. 111

[email protected]

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Vice President, Sales

Tel: +1 (301) 656-5900 ext. 160

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