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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
Program Highlights

The new Annex 1 revision was recently released! At this workshop, experts on the revision will answer your most pressing questions and provide solutions for implementation challenges at your organization.

Overview

This is the final workshop in a series that PDA has hosted in 2022 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.

This workshop 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 – 09:30 | P1: Overview of and Revision Process for Annex 1
    Moderator: Hal Baseman, MBA,
    Chief Operating Officer, ValSource Inc.

    Over the past four years, the revised Annex 1 has gone through multiple sets of industry review, comment, and revision. The current version presents a diverse, international perspective on regulatory expectations, recommendations, and requirements for modern sterile drug and biologic product manufacturing. The revised Annex 1 contains a significant amount of new and more detailed content on many topics. It places a heightened emphasis on the use of risk-based assessment and approaches to design and evaluate manufacturing contamination control. This session will provide insights from regulatory authorities involved in the Annex 1 development and review process of the revision, with a focus on the evolution, planning, and implementation of these changes.

    08:00 | Welcome Remarks from Workshop Co-Chair
    Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    08:20 | Regulatory Perspective
    Paul Gustafson,
    PIC/S Chairperson

    08:40 | Insights from a Former Regulator
    Tracy Moore, Director, TM Pharma Group Ltd

    09:00 | Q&A with Additional Panelist
    Abdelaali (Ali) Sarakha, Inspector, French National Agency for Medicines and Health Products Safety

    09:30 – 10:00 | Break in Exhibit Area

    10:00 – 11:15 | P2: Scope, Principles and Pharmaceutical Quality Systems
    Moderator: Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    This session opens our in-depth look at the content of the draft Annex 1. The Scope, Principles, and Pharmaceutical Quality System sections introduce the vision of the Annex 1 changes that track through all other sections. Talks will highlight Annex 1 focal points including contamination control strategy, quality risk management, and quality culture, including a discussion on the importance of human factors: knowledge, attitude, and experience. This session will also address the expanded scope of Annex 1 to include some non-steriles.

    10:00 | Using Quality Risk Management to Enable the Contamination Control Strategy
    Amanda M. McFarland, BS, Senior Consultant, ValSource Inc.

    10:20 | Aseptic Process Simulations
    Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    10:40 | Considerations of Annex 1 for Advanced Therapy Medicinal Products and Low Bioburden Products
    Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals

    11:00 | Q&A

    11:15 – 12:00 | Breakout Session 1

    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P1: Overview of and Revision Process for Annex 1 and P2: Scope, Principles, and Pharmaceutical Quality Systems.

    12:00 – 13:00 | Lunch

    13:00 – 14:15 | P3: Premises and Barrier Systems
    Moderator: Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions

    Aseptic manufacturing facilities come in a variety of shapes and sizes, from traditional aseptic through restricted access barrier systems (RABS) and into Isolators. This session will take a look at some of the key design and operational aspects that have been impacted by the revised Annex 1.

    13:00 | Cleanroom Design: Classification, Qualification, Air Visualization
    Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    13:20 | Cleanroom Operation: Disinfection, Transfer of Materials, Monitoring
    Donald C. Singer, MA, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences

    13:40 | Barrier Technologies: RABS and Isolators, Glove Integrity, Robotics, Decontamination
    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    14:00 | Q&A with Additional Panelist
    Rick L. Friedman, MS,
    Deputy Director, OMQ OC, CDER, U.S. FDA

    14:15 – 15:00 | Breakout Session 2

    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P3: Premises and Barrier Systems.

    15:00 – 15:30 | Break in Exhibit Area

    15:30 – 16:30 | P4: Equipment, Technology, and Utilities
    Moderator: Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    This session will discuss the impact of the Annex 1 revision on aseptic manufacturing facilities, specifically focusing on equipment design, indirect product contact parts, such as stopper bowls, and critical utilities, such as water systems.

    15:30 | Water Systems and Other Critical Utilities
    Biswarp Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals

    15:50 | Decontamination and Sterilization of Direct and Indirect Product Contact Surfaces
    Marcia C. Baroni, MBA, VP Quality Operations, Emergent BioSolutions

    16:10 | Q&A

    16:30 – 17:15 | Breakout Session 3

    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P4: Equipment, Technology, and Utilities.

    17:15 – 18:30 | Networking Reception

  • FRIDAY, 21 OCTOBER

    08:00 – 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
    Moderator: Marc Glogovsky, MS, S.M. (NRCM), Senior Consultant – Microbiology, ValSource Inc.

    Training and qualifying operators are of critical importance to ensuring proper aseptic technique and cleanroom behavior. Routine monitoring of personnel ensures that the qualified personnel are following the established procedures and that they can meet the strict gowning cleanliness requirements during normal operations. Trending and analysis of gloves and gown environmental monitoring (EM) data can provide critical feedback on individual operator performance, potential routes of contamination, specific gowning procedures, and overall training efficacy.

    08:00 | Day 1 Report Out
    Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    08:20 | Qualification and Training
    Marcia C. Baroni, MBA, , VP Quality Operations, Emergent BioSolutions

    08:40 | Gowning, Personnel Monitoring, and Beyond
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    09:00 | Q&A with Additional Panelist
    Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA

    09:15 – 09:45 | Breakout Session 4

    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment.

    09:45 – 10:15 | Break in Exhibit Area

    10:15 – 11:20 | P6: Production Technologies, Part 1
    Moderator: Amanda M. McFarland, BS, Senior Consultant, ValSource, Inc.

    This session will focus on the Annex 1 requirements for aseptic processing and filtration of sterile products. The aseptic processing discussion will address the types of operations and grades needed for aseptic preparation and processing operations. The filtration and sterilization presentation will provide insight into the different types of sterilization and the parameters needed to demonstrate success.

    10:15 | Aseptic Processing
    Frederic B. Ayers, Research Scientist, Eli Lilly and Company

    10:40 | Filtration and Pre-Use Post Sterilization Integrity Testing
    Brian Thome, PhD, Head, External Biologics and Gene Therapy Manufacturing Sciences, Biogen

    11:05 | Q&A

    11:20 – 12:00 | Breakout Session 5

    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing).

    12:00 – 13:00 | Lunch

    13:00 – 13:50 | P7: Production Technologies, Part 2
    Moderator: Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    This session will introduce some of the more intriguing topics covered and expanded in the revised Annex 1, which were selected based on input from the sterile product manufacturing community, as noted during prior meetings and discussions.

    13:00 | Container Closure Integrity Testing and Finishing
    Oliver P. Stauffer, MBA, CEO, Packaging Technologies & Inspection LLC

    13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)
    Patrick Poisson, EVP, Technical Operations, United Therapeutics Corp.

    13:40 | Q&A

    13:50 – 14:30 | Breakout Session 6

    Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P7: Production Technologies, Part 2 (Container Closure Integrity Testing and Finishing and Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization).

    14:30 – 15:00 | Break in Exhibit Area

    15:00 – 16:45 | P8: Aseptic Process Simulation and Environmental Monitoring
    Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.

    Aseptic process simulation (APS) has been identified as one of the key aspects of aseptic process control and monitoring. This session will review the related changes and begin discussing the interpretation and implementation of these recommendations and requirements. The presentations will focus on the Annex 1 requirements for APS (media fills) and environmental and process monitoring, including the new requirements and considerations for qualifying and operating a clean area and the extensive new requirements needed to successfully validate an aseptic process.

    15:00 | Environmental and Process Monitoring
    Marc Glogovsky, MS, S.M. (NRCM), Senior Consultant – Microbiology, ValSource, Inc.

    15:20 | Contamination Control Strategy Development
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    15:40 | Day 2 Report Out

    15:55 | Q&A and Final Discussion with Additioanl Panelists
    Rick L. Friedman, MS, Deputy Director, OMQ OC, CDER, U.S. FDA
    Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA (INVITED)

Highlighted Speakers

Frederic B. Ayers
Frederic B. Ayers
Eli Lilly and Company
Marcia C. Baroni
Marcia C. Baroni
Emergent BioSolutions
Hal Baseman
Hal Baseman
ValSource Inc.
Biswarup Dasgupta
Biswarup Dasgupta
Vertex Pharmaceuticals
Richard  Denk
Richard Denk
SKAN AG
Cheryl E. Essex
Cheryl E. Essex
Sanofi
Marc Glogovsky
Marc Glogovsky
Valsource, Inc.
Amanda McFarland
Amanda McFarland
ValSource, Inc.
Tracy Moore
Tracy Moore
TM Pharma Group Ltd
Patrick Poisson
Patrick Poisson
United Therapeutics Corp.
Donald C. Singer
Donald C. Singer
Ecolab Life Sciences
Oliver Stauffer
Oliver Stauffer
PTI - Packaging Tachnologies & Inspection

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

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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
Phone: +1 (888) 236-2427

Make a Reservation
Renaissance Palm Springs Hotel
  • 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. Please be aware that 1 nights deposit will be charged at booking when reserving a room at the Hilton Palm Springs. 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
Gov./Health Authority/Academic (Member/Non-Member) $700 $700
Student (Member/Non-Member) $350 $350
Early Career Professional (Member Only) $1,095 $1,095

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.

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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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