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Welcome, ISPE Canada Affiliate
Process Validation
A Life Cycle Approach
July 27, 2021 | 17:00-18:30
The session will give you an understanding of the concepts of the process validation lifecycle and the relationships between QbD, PPQ, or CPV activities. The presentation will cover some recent regulatory trends and how to practically apply the theories during execution.
Process validation has been an integral part of the cGMPs. Proving documented evidence of process adequacy has been considered as an organizational milestone for years. The same set of justifications live through multiple inspection scrutinies during the product's lifecycle. Hence, it has always been, and continues to be, a mechanism to provide excessively convincing proof of the process being in a qualified state at all times. If we consider the 1987 process validation guidance as a first step, the 2011 guidance is indeed a new approach needing a different mindset. The recent regulatory inspection trend indicates continued difficulties in adhering to the latest 2011 regulations. Let’s understand the guidance purpose and consciously embrace it. New process validation practitioners should find it easier to adopt the 2011 guidance and excel in practice, as they are not encumbered with the previous approaches.
Event Location
Online, via Zoom, a link will be sent prior to the event.
July 27, 2021
Genesis
Conceptual Differences: Current Vs Past PV
Enablers: Risk Assessment, Statistics
Stage 1—Process Design
Stage 2—Process Qualification
Stage 3—Continued Process Verification
Knowledge Management
Regulatory Actions
Legacy Products
References
Q&A
Attendee Registration
| Registration Category | Fee |
|---|---|
| ISPE Member | $10 |
| Non-Member | $15 |
Register now to attend this event
Speakers