Implementing ASTM Standard for Verification (C&Q)

Name:

Implementing ASTM Standard for Verification (C&Q) ( WEBASTMCQ )

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

Objectives:

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

URL:

CEUs:

.15

Member Price:

US Dollar EURO

Non Member Price:

US Dollar EURO

Instructors:

Steven Wisniewski

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