2021 PDA Contamination Control Strategy Workshop

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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 It will highlight a selection of best practices and identify outdated practices and mindsets to avoid.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.

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See Qualifying Criteria for Member Types.

Day 1

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

Day 2

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

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