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2021 Contamination Control Strategy Workshop

2021 PDA Contamination Control Strategy Workshop

Dec 08 - Dec 09, 2021
Eastern Standard Time | Online
  • Workshop
  • Online


The 2021 PDA Control Contamination Strategy Workshop will provide practical guidance on how to establish an effective CCS for either a new or existing drug manufacturing facility or process, according to existing regulatory standards and guidelines. It will highlight a selection of best practices and identify outdated practices and mindsets to avoid.

This workshop is based on the soon-to-be-published PDA Technical Report: Contamination Control Strategy. This technical report outlines how to implement an effective CCS using this holistic approach that covers facility design and utilities, environmental control, validation and monitoring, quality systems, people and processes.


  • Day 1
  • Day 2
  • Wednesday, 08 December

    09:30 – 11:00 | Plenary 1: Establishing the Foundation

    This session will discuss the key elements of a contamination control strategy – foundation, individual control, quality systems and governance. We will explore the foundations of scientific process and technical knowledge and discuss how facility design and environmental control contribute to contamination control.

    Holistic Contamination Control Strategy (CCS) Development in Pharmaceutical Manufacturing
    Biswarup DasGupta, Sarepta Therapeutics
    Cheryl Essex, Sanofi

    Facility Design and Utilities
    Frederic Ayers, Eli Lilly & Company

    Question and Answers


    11:15 – 13:00 | Plenary 2: Designing the Controls

    Environmental control is a fundamental part of the Contamination Control Strategy due to the contaminants from the environment that can enter the utilities, raw materials, equipment, and the process stream from the air and through surface transfer.

    Environmental Control, Validation and Monitoring
    Patrick Nieuwenhuizen, PharmaLex Ireland

    Equipment Design, Validation and Ongoing Control
    Jeff Gaerke, CAI

    Question and Answers

  • Thursday, 09 December

    09:30 – 11:00 | Plenary 3: Managing the Controls

    We will discuss the importance of personnel training and qualification programs. Contamination can be prevented by understanding and reducing specific hazards throughout the process, through a combination of strong CCS practices, quality culture, and continuous improvement.

    People and Process
    Don Singer, Ecolab Life Sciences
    Viral Contamination Control
    Martina Kopp,
    Amgen, Inc.

    Quality Systems: How They Support the CCS and the CCS Lifecycle
    Frederic Ayers, Eli Lilly & Company

    Question and Answers


    11:15 – 13:00 | Plenary 4: Implementing the Strategy

    The session will detail the implementation of the Contamination Control Strategy.

    Strategies for Implementing an Integrated Contamination Control Strategy
    David McFarland, GSK

    Panel Discussion
    David McFarland, GSK
    Patrick Nieuwenhuizen, PharmaLex Ireland

    Closing Remarks

Highlighted Speakers

Frederic B. Ayers
Frederic B. Ayers
Eli Lilly and Company
Biswarup Dasgupta
Biswarup Dasgupta
Vertex Pharmaceuticals
Cheryl E. Essex
Cheryl E. Essex
Jeff J. Gaerke
Jeff J. Gaerke
Patrick Nieuwenhuizen
Patrick Nieuwenhuizen
PharmaLex Ireland
Donald C. Singer
Donald C. Singer
Ecolab Life Sciences

Registration Fees

Registration Type Early Registration After 01 December
Member $837 $1,076
Non-Member $1,033 $1,328
Govern./Health Authority/Academic Member $392 $504
Govern./Health Authority/Academic Non-member $448 $576
Student Member $157 $202
Student Non-member $174 $223
Early Career Professional Member $419 $538

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