Product & Process Validation.
Current Best Practice …
“A hidden gem of knowledge”. (A. Thouars. Product Development. BioLife Solutions. Inc.).“Very informative”. (J. Winhart. Artes Biotechnology GmbH).
“Takes time to get through, but very informative. Well worth it”. (M. Mertin. Advanced Medical Solutions).
… IQ, OQ, PQ, Design Qualification, Cleaning Validation, Validation Gap Analysis, Validation Master Plan, Validation versus Verification, Protocol Reporting, Auditing for Validation compliance, Equipment, Facility, Material Validations, …
Products and Process Validation. Standards, Regulations & current Best Practices.
- Current and emerging best practices in Product and Process Validation.
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Develop your understanding:
Introduction to Product and Process Validation
Validation versus Verification
Integration of Risk into Validation
Validation Gap Analysis
Implementing a Validation Process (IQ, OQ, PQ)
The Validation Master Plan (VMP)
Validation during the Design processes
Software Validation
Cleaning Validation
Cleaning Process Sampling and Test Methods
Documentation Management for Validation compliance
Equipment, Component, Material and Facility Validation
Implementation of a re-Validation process
Protocol Reporting
Implementation of the Audit process to assure Validation effectiveness
Product & Process Validation.
Extracts
Combination products.
Validation testing.
Validation Planning.
Validation Gap Analysis
Process Validation
Product & Process Validation.