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2021 Contamination Control Strategy Workshop

2021 PDA Contamination Control Strategy Workshop

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

Overview

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 It will highlight a selection of best practices and identify outdated practices and mindsets to avoid.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

Agenda

  • 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. Discuss how facility design and environmental control contribute to contamination control.

    Setting the Stage: Overall View of the Cross Contamination Strategy

    Facility Design and Utilities

    Question and Answers


    Break

    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 can enter the utilities, raw materials, equipment, and the process stream from the air and through surface transfer. 

    Environmental Control, Validation and Monitoring

    Equipment Design, Validation and Ongoing Control

    Question and Answers


  • Thursday, 09 December

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

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

    People and Process

    Quality Systems and How They Support the CCS and the CCS Lifecycle

    Question and Answers


    Break

    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

    Panel Discussion

    Closing Remarks


Registration Fees

Register Now
Registration Type Regular Registration Price after 1 Dec 2021
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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Program Inquiries
  • Andrea Viera
    Assistant Director, Programs
    Tel: +1 (301) 656-5900 ext. 131
Exhibition Inquiries
Course Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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