Process Validation; The Impact Of FDA And ICH Guidances
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and has managed Analytical Research, Quality Control, and Quality Assurance functions for major pharmaceutical firms.
Since 1994 Dr. Lanese as consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.
Dr. Lanese lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry. Jerry is a member of the Editorial Board of the Journal of GXP Compliance and he is the co-author of a continuing series of articles in the Journal of GXP Compliance, “GXP Talk”.
In 2011, the FDA issued its Guidance for Industry, Process Validation: General Principles and Practices. This guidance integrates quality system concepts from ICH Q8, ICH Q9 and ICH Q10 including lifecycle and identifies the three stages of the process validation lifecycle. The Europeans followed with a similar guidance for process validation including the lifecycle concept. This has now been incorporated into the revised Annex 15: Qualification and Validation of the EU GMPs. Worldwide, the pharmaceutical community is approaching process validation as a process control tool that is applied to pharmaceutical production processes throughout the life of the process and the product. It is now a challenge for the process validation team to integrate a lifecycle approach into the development and validation of new processes and the verification of the validation of old processes.
In this webinar, we will discuss
- The FDA Guidance on process validation and how the expectations found in this guidance correlate to
o ICH Q10 : The Pharmaceutical Quality System
o ICH Q9 : Quality Risk management
o ICH Q8 : Pharmaceutical Development
o FDA Quality Metrics Guidance
- The three stages of process validation and what must be done during each stage
o Stage 1 : Process Design
o Stage 2 : Process Qualification
o Stage 3 : Continued Process Verification
- The extension of the concept of process lifecycle to test method validation
Attendees will better understand contemporary expectations for process validation and how these support the quality system approach to compliance.
The objective of this webinar is to provide the attendees with a better understanding of contemporary expectations for process validation and how these support the quality system approach to compliance.
Who Should Attend
- Management at all levels who are responsible for process development and validation
- Personnel who are responsible for
o Product development
o Process transfer
o Process validation
o Demonstration that a process continues to perform in a state of control
- QA, personnel who are responsible for the review and approval of process validation protocols and reports
- Validation specialists