FDA Process Validation Guidance: A Review with Implications for C&Q

Name:

FDA Process Validation Guidance: A Review with Implications for C&Q ( WEBFDAPVG )

Description:

A review of the recent changes in the FDA's thinking on lifecycle based process validation as published in their long awaited update to the 1987 PV guidance. This presentation provides an overview of the key elements of the draft and looks in particular at the role that verification/CQ can play in supporting these outcomes.

Objectives:

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

Understand the current FDA thinking on lifecycle based process validation

Understand the implications for the process design and process qualification phases of the lifecycle

Prepare your organization with the skills expected to support the new requirements necessary for continued process verification

URL:

CEUs:

.10

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Non Member Price:

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Instructors:

eLearning