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2023 Contamination Control Strategy Workshop

2023 PDA Contamination Control Strategy Workshop (Raleigh)

Mar 01 - Mar 02, 2023
Raleigh, NC

  • Workshop
  • The Americas

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Program Highlights
All Workshop participants will receive an electronic copy of the new PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR90) when it is released in early February!

The early registration deadline has been extended until 29 January!

Can't make it to Raleigh? PDA is also hosting another Contamination Control Strategy Workshop in New Orleans, LA from 06-07 April!

Overview

Join us in Raleigh for the 2023 PDA Contamination Control Strategy Workshop – 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 PDA’s newest Technical Report, 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

  • Biswarup Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals and Workshop Co-Chair
  • Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi and Workshop Co-Chair
  • Frederic B. Ayers, Research Scientist, Eli Lilly and Company
  • Bianca Bohrer, Managing Director, PSM GmbH
  • Richard Denk, Senior Consulting Aseptic Processing & Containment, SKAN AG
  • Jason Gale, Microbial Control Manager, Pfizer Inc.
  • Liliana Gamboa, MSc, Head of Biologics Microbiological Control, Sanofi
  • Marc Glogovsky, MS, Business Unit Manager/Senior Consultant – Microbiology, Valsource, Inc.
  • Thorsten Haefner, MBA, Vice President of Business Development, PSM GmbH
  • Madison Hoal, Global Technical Consultant, Ecolab Life Sciences
  • Chris Knutsen, PhD, Technical Fellow, Microbiology, Bristol Myers Squibb
  • Patrick Mains, Senior Consultant, ValSource, Inc.
  • Amanda M. McFarland, MS, Senior Consultant, ValSource, Inc.
  • Donald C. Singer, MA, ASQ Fellow, CPGP, Senior Microbiology Technical Consultant, North America, Ecolab Life Sciences
  • Kim Sobien, MBA, MSAT Contamination Control Lead and GSK Fellow, GSK
  • James Wamsley, Consultant, ValSource, Inc.

Agenda

  • Day 1
  • Day 2
  • WEDNESDAY, 01 MARCH

    09:15 – 11:00 | P1: A Path for Quality and Safety
    Moderator: Biswarup Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals

    In this opening 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
    Biswarup Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    09:30 | How We Got Here
    Biswarup Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    09:55 | Case Study
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi
    Madison Hoal,
    Global Technical Consultant, Ecolab Life Sciences

    10:40 | Q&A

    11:00 – 11:30 | Break in Exhibit Area

    11:30 – 12:45 | Small Group Activity
    Moderator: Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    In this session, participants will use the concepts and tools introduced in the previous session to begin drafting their own contamination control strategies. There will be ample time for discussion with their facilitator and peers.

    11:30 | Activity Introduction
    Madison Hoal, Global Technical Consultant, Ecolab Life Sciences

    11:40 | Individual Work on Own Process

    11:55 | Group Discussion

    12:45 – 13:45 | Networking Lunch

    13:45 – 15:25 | Rotating Stations
    Moderator: Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    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 (APS), etc.)
    • Station 3: Personnel/Training (topics include awareness, culture, governance, training/qualification, gowning, aseptic process simulation (APS), etc.)
    • Station 4: Equipment/Barrier Technologies (topics include cleaning validation, gloves, barrier technologies, single-use technologies, robotics, etc.)

    13:45 | Activity Orientation
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

    13:55 | Rotation 1

    14:35 | Break and Station Switch

    14:45 | Rotation 2

    15:25 – 16:00 | Break in Exhibit Area

    16:00 – 17:00 | P2: Day 1 Report Outs and Q&A
    Moderator: Biswarup Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals

    Day 1 will close out with a report out from and Q&A with the SME station facilitators.

    16:00 | Station Report Outs

    16:45 | Day 1 Wrap Up and Q&A

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

  • THURSDAY, 02 MARCH

    09:00 – 10:40 | Rotating Stations
    Moderator: Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

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

    09:00 | Welcome and Activity Reorientation
    Cheryl E. Essex, MS,
    Head of Quality Operations R&D Genomic Medicines, Sanofi

    09:10 | Rotation 3

    09:50 | Break and Station Switch

    10:00 | Rotation 4

    10:40 – 11:00 | Networking Refreshment Break

    11:00 – 12:30| P3: Day 2 Report Outs and Q&A
    Moderator: Biswarup Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals

    The Workshop will close with a final report out from the SME station facilitators and a final opportunity for small group discussion.

    11:00 | Station Report Outs

    11:25 | Small Group Discussion

    11:55 | Q&A and Wrap Up

    12:15 | Closing Remarks from Workshop Co-Chairs
    Biswarup Dasgupta, MS, Site Quality Head, VMC, Vertex Pharmaceuticals
    Cheryl E. Essex, MS, Head of Quality Operations R&D Genomic Medicines, Sanofi

Networking Opportunities

WEDNESDAY, 01 MARCH

  • 11:00 – 11:30 | Refreshment Break in Exhibit Area
  • 12:45 – 13:45 | Networking Lunch
  • 15:25 – 16:00 | Refreshment Break in Exhibit Area
  • 17:00 – 18:00 | Reception in Exhibit Area

THURSDAY, 02 MARCH

  • 10:40 – 11:00 | Networking Refreshment Break

Highlighted Speakers

Frederic B. Ayers
Frederic B. Ayers
Eli Lilly and Company
Biswarup Dasgupta
Biswarup Dasgupta
Vertex Pharmaceuticals
Cheryl E. Essex
Cheryl E. Essex
Sanofi
Madison  Hoal
Madison Hoal
Ecolab Life Sciences
Amanda McFarland
Amanda McFarland
ValSource, Inc.
Donald C. Singer
Donald C. Singer
Ecolab Life Sciences

Additional Information

  • Who Should Attend

    More information coming soon.

Got a Question? We have answers

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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.

Raleigh Convention Center

500 South Salisbury Street
Raleigh, NC

Raleigh Convention Center

The Workshop will take place at the Raleigh Convention Center (500 S Salisbury Street). PDA does not have a block of hotel room, but recommends these nearby hotels:

  • Raleigh Marriott City Center
  • Residence Inn Raleigh Downtown
  • Sheraton Raleigh
  • How to Get Here

    By Air

    Raleigh-Durham International Airport is approximately 20 minutes northwest of the RCC. Ground transportation to and from the airport is provided by the Raleigh-Durham International Airport Taxi Service, GoTriangle, and local limousine and shuttle companies. Many hotels also offer shuttle service to and from the airport.

    By Car

    The Raleigh Convention Center is adjacent to the Red Hat Amphitheater and is located at 500 South Salisbury Street, Raleigh, NC 27601. From Points West: I-40 east to exit 298B South Saunders Street. From Points East: 64/264 to I-440 east; merge onto I-40 west and exit at 298B South Saunders Street. From Points South: US-1 north to I-40 east; exit at 298B South Saunders Street. From Points North: US-1 South into the city - left on Lenoir Street.

    Other Options

    The regional bus system, GoTriangle, offers service throughout the Greater Raleigh and Triangle area. Stops are located throughout Downtown Raleigh and can take visitors to neighboring such as Cary, Morrisville, Research Triangle Park, Durham, and Chapel Hill. Visit gotriangle.org for more information.

    Directions

    Registration Fees

    Early Registration
    REGISTRATION TYPE BY 29 JANUARY
    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 29 JANUARY
    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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