• 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

A Beginner's Guide to Process Validation

2,999 599

(Price for 30 day access)

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..

What's inside

  • 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

Additional information

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.

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.

What happens after I purchase this module?

Watch this 2 minute video to see the cart and checkout processes, and how to access your modules on our Learning Management System (LMS) after purchase.