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 tèam 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 specìal 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 Drùg Substances
USP Stimulus article on Test Method Validation
FDA Guidance – Quality Metrics
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-1: Process Validation: How did we get here, the Process Validation Guidance, and Process Validation Lifecycle, Stages 1 and 2
Duration: 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
Duration: 120 minutes
FDA Process Validation Guidance – Stage 3
EU process Validation Guidance
FDA Quality Metrics and its impact on Process Validation
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