A Beginner's Guide to Process Validation
This module focuses on the practical applications of the lifecycle approach to all stages of Process Validation (PV). It provides insight into regulations guidance, and best practices around PV utilized across the industry.
The lifecycle approach of Process validation
Requirements of FDA 2011 and EU 2014 and 2016 guidance on process validation with emphasis on 2015 EU GMP Annex 15
The practical expectations for a three-stage approach
Process design, equipment and process qualification - ongoing/continued process verification
Process Validation/Process Performance Qualification (PV/PPQ)- Protocol - acceptance criteria and report
Continued Process Verification-maintaining a state of control over the product lifecycle
Why it matters
Lifecycle Process Validation (PV) remains one of the most important, yet, commonly misunderstood topics in the pharmaceutical industry. Application of science and risk-based approach to validation can deliver business efficiency and increased reliability, while enabling robust processes and assuring product quality.
Who is it for
This course is ideal for technical and managerial personnel responsible for facility, utility, and equipment qualification and process validation. It Is also relevant to quality assurance (QA) personnel.