NEW! One-day Life Cycle Process Validation Training

Rescop Academy is providing the training Life Cycle Process Validation Foundation level on November 19th in The Netherlands.

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.

Course content

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?

Program

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

Dates & Location

November 19th 2019
Utrecht
The Netherlands

Investment

Special Introduction Price € 525,- (Regular Fee € 595,-)
Prices listed are excl. VAT