FDA Pharmaceutical Process Validation Guidance Virtual Bootcamp
Pharmaceutical Process Validation
Virtual Boot Camp
Presented By: Dr. John G. (Jerry) Lanese
PRE-RECORDED
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Demonstrating Process Performance Through the Process Lifecycle Concept
Overview:
Since the introduction of the “The Pharmaceutical Quality System” (ICH Q10) in 2008, the lifecycle approach has been applied to all aspects of pharmaceutical products and processes. 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 the lifecycle and identifies the three stages of the process validation lifecycle.

In order to optimize performance through the lifecycle concept, it’s important to understand the contemporary expectations for process validation and how these support the quality system approach to compliance. Additionally, this will help your process validation team integrate a lifecycle approach into the development and validation of new processes and the verification of the validation of old processes.

Join expert speaker John G. Lanese for our special Pharma Process Validation Virtual Boot Camp, where attendees will learn about the background of process validation from the FDA Process Validation Guidance of 1987 to the regulatory expectations of today, as identified in the 2011 FDA Process Validation Guidance and the EU GMPs. The discussion will show how these validation specific documents relate to:

  • ICH Q8, Pharmaceutical Development
  • ICH Q9, Quality Risk Management
  • ICH Q10, The Pharmaceutical Quality System
  • ICH Q11, Development and Manufacture of Drug Substances
  • USP Stimulus article on Test Method Validation
  • FDA Guidance – Quality Metrics
Session Highlights:
  • Validation up to 2001
  • FDA Process Validation Guidance
  • Validation lifecycle and the three stages
  • Stage 1 – Process Development
  • Stage 3 – Process Qualification
  • Validation Stage 3 – Continued Process Verification and Quality Metrics and the Product Quality Review
  • Current FDA expectations
Session Details
Session-1: Process Validation: How did we get here, the Process Validation Guidance, and Process Validation Lifecycle, Stages 1 and 2

Length: 120 minutes

  • Process Validation before 2001
  • Process Validation 2001 to 2011
  • FDA 2011 Process Validation Guidance Stage 1 and 2
  • Process Validation Lifecycle
Session-2: Process Validation Lifecycle – Stage 3 and the Impact of Quality Metrics

Length: 120 minutes

  • FDA Process Validation Guidance – Stage 3
  • EU process Validation Guidance
  • FDA Quality Metrics and its impact on Process Validation
Who Should Attend?
  • Senior management
  • QA directors, managers
  • Process validation professionals
  • Test method validation professionals
  • Quality control personnel
  • Laboratory operations professionals
  • Personnel in analytical development involved in developing new methods
About Our Speaker
Jerry LaneseDr. 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 began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.
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