GMPs for ATMP

This is how your training course could look like:

Do you need an individual offer for your company?

Send us an e-mail indicating your topic(s) of interest.

Please note that we need about 3 months preparation for the organisation of your in-house training course.

Below is an example of a 2 day inhouse training course.

Content Day 1
  • Introduction
  • Oveview on recent developments on EU GMP Regulations
    • GMPs for marketed products
    • GMPs for IMPs
    • GMPs for ATMPs
    • Brexit
    • Developments in MRAs (USA, Japan, Switzerland…)
  • Time for questions and discussion
  • The new GMP guidelines for ATMPs
    • Comparison to EU GMP part I and II
    • Key elements and GMP tools for ATMP manufacturers
    • Case study dependent on product
  • Data Integrity
    • Chapter 4 EU GMP Part I and Annex 15
    • PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments 
    • Paper based, electronic or hybrid documentation approaches
    • Case study(ies)
  • Time for questions and discussions
  • The new Annex 1 EU GMP for sterile dosage forms
    • Discussion on applicability and consequences
    • Comparison Annex 1 2007 versus Annex 1 2018
    • Relevant changes
    • Discussion on applicability and consequences
  • Time for questions and discussions
Content Day 2
  • Zone concept in sterile manufacturing
    • Annex 1
    • Schemes
    • Loggers
    • Case Study
  • Time for questions and discussions
  • Good documentation practice
    • Chapter 4
    • PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
  • Time for questions and discussions
  • Isolator
    • GMP for ATMPs and isolators
    • Importance of isolators to ATMPs
    • Case study
  • Time for questions and discussion
  • Current questions from practise in the company
    • Discussion of current practical questions
    • Examples of some solutions in light of GMP rules
  • Final discussion

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GMP Conferences by Topics

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