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2023 Contamination Control Strategy Workshop

2023 PDA Contamination Control Strategy Workshop (Charlotte)

Dec 06 - Dec 07, 2023
Charlotte, NC

  • Workshop
  • The Americas
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Program Highlights

The PDA Contamination Control Strategy Workshop in Raleigh sold out earlier this year! Make sure to register by 22 October to save up to $500 in registration fees!

All workshop participants will receive an electronic copy of the new PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR 90)!

Overview

PDA’s most interactive workshop ever!

Key to this workshop is more than eight hours of hands-on small group activities and discussions facilitated by recognized industry experts. Learn not only the theory of developing a great contamination control strategy (CCS), but also how to translate that theory into actual practice. Gain the skills you need to create holistic contamination control strategies covering all aspects of the manufacturing operation, including facility design and utilities, environmental control, validation and monitoring, quality systems, people, and processes.

This workshop is based on the new PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR 90), which will be provided free to each participant as a tool to prepare for the workshop. Jumpstart your CCS understanding and how to apply it to your manufacturing facilities and processes in this world-class interactive workshop – your hands-on solution to developing and implementing a successful CCS!

SUBJECT MATTER EXPERTS

  • Frederic Ayers, ValSource, Inc. (Co-Chair)
  • Tracy Moore, TM Pharma Group Ltd (Co-Chair)
  • Marcia Baroni, Emergent BioSolutions
  • Richard Denk, SKAN AG
  • Chris Knutsen, Bristol Myers Squibb
  • Christopher Murdock, Bristol Myers Squibb
  • Nidhi Shah, Bristol Myers Squibb
  • Donald Singer, Ecolab Life Sciences
  • Kim Sobien, ValSource, Inc.
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Agenda

  • Day 1
  • Day 2

  • Wednesday, 06 December

    08:00 – 18:00 | Registration Open

    08:00 – 09:15 | Continental Breakfast

    09:15 – 10:45 | P1:Developing a Contamination Control Strategy
    Moderator: Tracy Moore, Director, TM Pharma Group Ltd.

    In this session, the presenters will review PDA’s approach to the development of a contamination control strategy. Using a case study, they’ll also discuss how to identify contamination risks, embed quality risk management (QRM) risk principles, and implement appropriate controls.

    09:15 | Welcome Remarks from Workshop Co-Chairs and TR Introduction
    Frederic B. Ayers,     Senior Consultant, Valsource, Inc.
    Tracy Moore,     Director, TM Pharma Group Ltd.

    09:50 | QRM as a Foundation to CCS
    Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.

    10:10 | CCS Case Study
    Kim Sobien, Senior Consultant-Microbiology, ValSource, Inc.

    10:30 | Q&A

    10:45 – 11:15 | Networking Break in the Exhibit Area

    11:15 – 12:30 | Small Group Breakout
    Moderator: Marcia C. Baroni, MBA, VP Enterprise GxP Compliance & Systems, Emergent BioSolutions

    In this session, participants will use a hands-on tool to begin evaluating their own contamination control strategies. There will be ample time for discussion with their facilitator and peers. Each topic will open with a short overview of considerations from the TR, then time for individual evaluations followed by table discussion.

    11:15 | Introduction to the Breakout Activity
    Marcia C. Baroni, MBA, VP Enterprise GxP Compliance & Systems, Emergent BioSolutions

    11:35 | TR90 Overview: Personnel/Training
    Donald C. Singer, MA ASQ Fellow, CPGP, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences

    11:45 | Individual Work

    11:55 | Breakout Discussion

    12:30 – 13:30 | Networking Lunch

    13:30 – 14:45 | Small Group Breakout
    Moderator: Kim Sobien, MBA, Senior Consultant-Microbiology, ValSource, Inc.

    In this session, participants will use a hands-on tool to begin evaluating their own contamination control strategies. There will be ample time for discussion with their facilitator and peers.

    13:30 | TR90 Overview: Process Design
    Frederic B. Ayers, Senior Consultant, ValSource, Inc.

    13:40 | Individual Work

    13:50 | TR90 Overview: Vendor/Material
    Chris Knutsen, PhD,     Technical Fellow, Microbiology, Bristol Myers Squibb

    14:00 | Individual Work

    14:10 | Group Discussion

    14:45 – 15:15 | Networking Break in the Exhibit Area

    15:15 – 16:30 | Rotating Stations
    Moderator: Tracy Moore, Director, TM Pharma Group Ltd.

    Participants will rotate through four different stations, each led by SME facilitators, focusing on a key section of TR90. Upon joining each station, participants will select which sub-topic they would like to start the discussion with and then facilitators will guide the conversation through the rest of the topics. All participants will be randomly assigned to a group and will have the opportunity to rotate through all four stations (two station on Day 1 and two station on Day 2).

    • Station 1: Facility/Utility (topics include environmental monitoring performance qualification, environmental monitoring, maintenance, utility, start-up, facility flow, validation, etc.)
    • Station 2: Raw Material/Process (topics include opening processing, viral risk, in-process testing strategy, advanced therapy medicinal products (ATMPs), container closure integrity testing (CCIT), aseptic process simulation (e.g., media fills, etc.)
    • Station 3: Personnel/Training (topics include awareness, culture, governance, training/qualification, gowning, aseptic process simulation (“media fills”), etc.)
    • Station 4: Equipment/Barrier Technologies (topics include cleaning validation, gloves, barrier technologies, single-use technologies, robotics, etc.)

    15:15 | Activity Orientation
    Tracy Moore, Director, TM Pharma Group Ltd.

    15:25 | Rotation 1

    15:55 | Station Switch

    16:00 | Rotation 2

    16:30 – 17:00 | P2: Day 1 Wrap up and Q&A
    Moderator: Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.

    Wrap up for day 1 with a Q&A Panel with the day’s presenters.

    16:30 | Q&A and Wrap Up
    Frederic B. Ayers,     Senior Consultant, ValSource, Inc.
    Chris Knutsen, PhD, Technical Fellow, Microbiology, Bristol Myers Squibb
    Kim Sobien, MBA, Senior Consultant-Microbiology, ValSource, Inc.

    17:00 – 18:00 | Reception in Exhibit Area

  • Thursday, 07 December

    07:00 – 12:30 | Registration Open

    07:00 – 08:00 | Continental Breakfast

    08:00 – 08:45 | P3: Creating a CCS Document
    Moderator: Frederic B. Ayers, Senior Consultant, ValSource, Inc.

    This interactive session will cover the CCS structure proposed in TR90 and give some practical guidance on how to structure the CCS document hierarchy for multi-product facilities.  

    08:00 | Creating a CCS Document and CCS Lifecycle Management
    Tracy Moore, Director, TM Pharma Group Ltd.

    08:25 | Q&A

    08:45 – 10:00 | Small Group Breakout
    Moderator: Nidhi Shah, MBA, Senior Director, Bristol Myers Squibb

    In this session, participants will use a hands-on tool to begin evaluating their own contamination control strategies. There will be ample time for discussion with their facilitator and peers. 

    08:45 | TR90 Overview: Equipment/Barrier Tech
    Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG

    08:55 | Individual Work on Own

    09:05 | TR90 Overview: Facility/Utility
    Donald C. Singer, MA, ASQ Fellow, CPGP, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences

    09:15 | Individual Work on Own

    09:25 | Group Discussion

    10:00 – 10:20 | Networking Break in the Exhibit Hall

    10:20 – 11:35 | Rotating Stations
    Moderator: Frederic B. Ayers, Senior Consultant, ValSource, Inc.

    Participants will regroup and complete their station rotations that were started on the previous day.

    10:20 | Welcome Back and Activity Reorientation
     Frederic B. Ayers, Senior Consultant, ValSource, Inc.

    10:30 | Rotation 3

    11:00 | Group Switch Break

    11:05 | Rotation 4

    11:35 – 12:30| P4: Day 2 Report Out and Wrap Up
    Moderator:  Frederic B. Ayers, Senior Consultant, ValSource, Inc.

    The Workshop will close with a final report out from the SME station facilitators and a final opportunity for questions from attendees.

    11:35 | Station Report Outs

    11:55 | Q&A and Panel Discussion with Station Leads

    12:25 | Closing Remarks from Workshop Co-Chairs
    Frederic B. Ayers, Senior Consultant, Valsource, Inc.
    Tracy Moore, Director, TM Pharma Group Ltd

Additional Information

  • Who Should Attend

    More information coming soon.

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Harris Conference Center

3216 CPCC Harris Campus Dr.
Charlotte, NC

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Registration Fees

Early Registration
Registration Type By 22 October
Member $1,595
Non-Member $1,995
Gov./Health Authority/Academic (Member Only) $795
Early Career Professional (Member Only) $1,295
Student (Member Only) $495
Regular Registration
Registration Type After 22 October
Member $2,095
Non-Member $2,495
Gov./Health Authority/Academic (Member Only) $895
Early Career Professional (Member Only) $1,395
Student (Member Only) $595

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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