Implementing the ASTM Standard for Verification (C&Q)

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eLearning

80 Minutes

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Presenter

Steven J. Wisniewski, Senior Associate and Director of Compliance, IPS

How You Will Benefit

At the conclusion of this session, participants will be able to:

Relate the ASTM Standard to GMP regulations and guidance documents
Explain the regulatory foundation for the risk-based approach
Understand the 2001 ISPE Baseline® Guide: Commissioning and Qualification Volume 5 and how it links to new concepts in the upcoming Baseline Guide: Science and Risk-Based approach for the Delivery of Facilities, Systems, and Equipment
Differentiate qualification versus verification
Differentiate between the new risk assessment approach versus the old one
Understand how the new draft USFDA Process Validation Draft links to ASTM E 2500
Understand the details on verification process flow
Implement verification through the C&Q process (FAT, SAT, IV, FV, PT)
Understand ways GEP can be used as a foundation for verification

Description

Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle

Who Should Participate

Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.

Presenter Biography

Steven J. Wisniewski is Senior Associate and Director of Compliance for Integrated Project Services (IPS), a full-service engineering firm specializing in the delivery of technical complex projects, and that offers complete design/build, commissioning, validation and FDA compliance services for the pharmaceutical, biotech, health care, and specialty manufacturing industries. Wisniewski has more then 30 years experience in the pharmaceutical, biotech, and device industries. Currently, Wisniewski is chairman of the ISPE Community of Practice for Commissioning and Qualification, and is on the ISPE task team developing the revised ASTM Verification Standard and the new C&Q Baseline® Guide: Science and Risk-Based approach for the Delivery of Facilities, Systems, and Equipment, Volume 12 to support implementation of ASTM E 2500.