Modern Qualification & Validation

11-12 September 2018, Berlin, Germany

Course No. 16636



Speakers from EU and FDA Inspectorate

Dr Rainer Gnibl, District Government of Upper Bavaria, Germany
Grace McNally, FDA, Senior Policy Advisor

Industry Speakers

Dr Clemens Borkenstein, ZETA
Franco Casinelli, Johnson and Johnson
Dr Berthold Düthorn, Robert Bosch Packaging Technology
Mareille Fuß, Boehringer Ingelheim
Gert Moelgaard, Moelgaard Consulting, Head of ECA's Validation Group
Markus Multhauf, Senior Consultant GMP Engineering
Dr Thomas Schneppe, Bayer AG
Stéphanie Sénéchal, NNE
Sion Wyn, Conformity Ltd


Qualification and Validation regulations have changed in both Europe and USA in recent years. Many pharmaceutical companies and suppliers are still using methods and documentation from previous practice although a risk-based approach has become a regulatory expectation. Also many companies have very little integration between their activities, so the overall qualification and validation effort is complicated, expensive and time consuming. Only few companies have successfully integrated their qualification and validation programs, as the EU Annex 15 and the FDA Process Validation guide enables.

This Modern Qualification and Validation conference is about cost-effective and time saving integrated qualification and validation. Suppliers of equipment, facilities, engineering etc. can are an important factor in this.

A team of pharmaceutical companies and suppliers have developed a new ECA Good Practice Guide: “Modern Qualification – A guide to cost effective qualification based on Customer - Supplier Partnership”. The first public draft of this guide will be presented.

The team behind the draft guideline will be present and there will be participants from regulatory authorities from EU and USA. Participants will have the opportunity to review and discuss the contents and technical aspects of the guidance document, its scope and practical application and to discuss. All delegates will receive a copy of the guide free of charge. Three case studies regarding fast track qualification projects and inspector´s expectations on such projects will also be presented.


Qualification of equipment has been mandatory since the late 80s (FDA Guideline on Process Validation) and the early 90s (EU GMP Guide). Due to inspection results at that time, qualification activities increased significantly and very often the focus on the patient was lost. The original purpose behind qualification, which is to show that equipment is fit for its intended use, was lost. A white paper from the ISPE “Risk-based qualification for the 21st century" tried to amend this. With reference to this paper, ECA´s Validation Group has now developed a Good Practice Guide on Modern Qualification – A guide to cost effective qualification based on Customer - Supplier Partnership. This guide is supposed to assist pharmaceutical companies and suppliers with how to qualify in fast track projects. Like in the GAMP Guide practical documentation, examples build the core of this Good Practice Guide

Target Group

Everyone who may be influenced by the Annex 15 revision and FDA Process Validation Guidance regarding Qualification/Verification and Process Validation acitivities and want to see how an integrated approach to qualification and validation can enable successful fast-track.


Introducing the ECA Guideline: Modern Qualification - A guide to cost effective qualification based on Customer - Supplier Partnership

  • Development of ECA´s Modern Qualification guideline
  • Content of the guideline
  • Application of the guide by suppliers and users
  • Fit into the GMP regulations
  • Benefit for involved parties
  • Outlook
Modern Qualification and Validation acc. EU GMP Annex 15: Inspector´s View
  • Qualification Life Cycle (Overview)
  • Boundaries & Possibilities of Annex 15
  • What is a must, what is a nice to have
  • Linking of Qualification & Validation possible?
Modern Qualification and Validation from an FDA perspective
  • FDA’s Process Validation guide
  • Process Validation as a life-cycle approach
  • Lessons learned from the FDA Process Validation guide
  • International harmonization of process validation?
Supplier Guidelines: The history of the GAMP Guide and its impact
  • The need for guidance – objectives and drivers
  • The Long and Winding Road
  • Lessons learnt, and what the future holds…
Overview of current industry guidelines on Qualification and Validation
  • ISPE Guides on C&Q, risk-based qualification and process validation
  • GAMP® 5 guide on Computerised Systems
  • PDA guides on process validation
  • ECA guide on process validation
Qualification and Validation: An integrated approach
  • PQ the „marriage“ of qualification and process validation
  • Integration of critical process parameters into qualification
  • The real goal is PPQ
  • Key performance indicators in qualification and validation (Cm, CmK, Cp, CpK, Pp, PpK)
The role of the User Requirement Specification (URS) for successful pharmaceutical equipment projects
  • Requirements for a successful URS
  • The process from URS to approved design documents
  • Important players during creation of URS and design documents
  • Case study Octapharma Vienna
Good Engineering Practice – leverage the quality system of a good pharma equipment supplier
  • What is GEP?
  • GEP guidelines
  • Commissioning vs Qualification
  • GEP in the GMP environment
Case Study: Science and risk-based Commissioning and Qualification – J&J Pharmaceutical Plant in Xiang
  • Project Overview – risk-based approach
  • PPURS and URS
  • Risk assessment
  • Test matrices
  • Commissioning
  • Outcomes in numbers
Case Study: Verification approach as enabler of Fast track execution
  • Risk-based approach
  • Risk assessment defined for module
  • Modularisation/bigger packages – less suppliers to audit
  • No IQ/OQ performed – switch directly from SAT to PQ after verification
Case Study: Fast track project executions
  • Presentation of outline data and boundary conditions for fast track projects
  • Important milestones in the project
  • Objective for fast track project and determinations
  • Success factors and challenges in the project
Two tutorial workshops about “What should be in an URS to ensure a successful project?” and “Quality Risk Assessment and Critical Aspects” ensure the transfer from theory into practice.


This course is part of the GMP Certification Programme "ECA Certified Validation Manager" Learn more

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