Life Cycle Process Validation Training

Rescop provides Life Cycle Process Validation (LCPV) training on two different levels: Foundation and Practitioner. Both training levels cover both the “2011 FDA Process Validation Guidance” and the “2015 EMA Annex 15 on Process Validation”.

The Foundation Training is suitable for people who need to be aware what Life Cycle Process Validation is and what is generally required for its implementation. This training has a duration of 1 day.

The Practitioner Training is suitable for validation and technical operations associates who are involved with Process Performance Qualification (PPQ) and with Continued Process Verification (CPV). This training has a duration of 1 day for PPQ and 1 day for CPV.

Both can be booked in our Open Classroom Schedule at one of our training locations, or as In-Company training at your site.

Life Cycle Process Validation Foundation

The LCPV Foundation Training will include the theory behind LCPV, the three stages of LCPV, combined with the practical experience of our trainers. The Foundation Training is focusing on the basics of LCPV and is meant for management and associates from QA, Validation and Technical Operations employees involved in review and approval of LCPV documents. Foundation certification is mandatory for the Practitioner Training.

Topics regarding LCPV will be discussed, like:

  • What has changed with the life cycle validation approach and why is such a change made?
  • What are the differences regarding LCPV between FDA and EMA?
  • What is a Process Performance Qualification?
  • What is a Continued Process Verification?

Life Cycle Process Validation Practitioner

The LCPV Practitioner training is setup to teach associates involved in the hands-on protocol writing, determination of statistically justified sampling plans, protocol execution, statistical analysis and reporting of PPQ and CPV. It’s mandatory that the Foundation training has been performed first.

Topics regarding LCPV will be discussed, like:

  • How to determine statistically justified sample sizes?
  • How to determine the number of PPQ batches?
  • How to determine what for CPV needs to be monitored?
  • What risk-based approaches can be used during stage 3?

Program LCPV Foundation

1 Day

  • Intro – Module A – Introduction in LCPV
  • Intro – Module B – Details of the FDA Guidance
  • Intro – Module C – Details of the EMA Annex 15
  • Intro – Module D – Summary of the differences between FDA and EMA
  • Intro – Module E – Introduction in LCPV Stage 2 – Process Performance Qualification (PPQ)
  • Intro – Module F – Introduction in LCPV Stage 3 – Continued Process Verification (CPV)

Program LCPV Practitioner

Day 1 – Process Performance Qualification

  • PPQ – Module A – Introduction and sampling uncertainty
  • PPQ – Module B – PPQ Sampling Plan
  • PPQ – Module C – Number of PPQ batches
  • PPQ – Module D – Attribute Testing AQL and RQL
  • PPQ – Module E – PPQ and CPV Stage 3a Plan

Day 2 – Continued Process Verification

  • CPV – Module A – Introduction
  • CPV – Module B – CPV-Matrix
  • CPV – Module C – Control Charting
  • CPV – Module D – Process Capability
  • CPV – Module E – Risk Based Approach to CPV
  • CPV – Module F – Baseline Performance and Transition to CPV Stage 3b