Maik Guttzeit
Freelance Consultant
Referent:innen
Rafael Leandro de Souza
NNE Pharmaplan
Dr Christian Grote-Westrick
B. Braun Avitum
Ralf Gengenbach
gempex
Dr Rainer Gnibl
GMP Inspector
Dr Jean-Denis Mallet
Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Zielgruppe
Everyone who may be influenced by the Annex 15 revision and FDA Process Validation Guidance regarding Qualification/Verification and Process Validation activities and want to see how an integrated approach to qualification and validation can enable successful, lean projects. Also addressed are pharmaceutical companies, API and excipients manufacturer and of course equipment suppliers and engineering companies.
Zielsetzung
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 to prevent changing all procedures already set. Still many companies have very little integration between their activities, so the overall qualification and validation effort is complicated, expensive and time consuming. But some companies have leverage their qualification and validation programs to a fully integrated approach, as the EU Annex 15 and the FDA Process Validation guide enables.
Qualification is an activity with a history of more than 25 years, but it is still hotly debated. Even modern approaches, aimed at time and cost optimization, do not seem to bring about the expected improvement. A non-harmonized terminology emerges as one of the main problems, especially when it comes to the integration of good engineering practice/commissioning activities with qualification activities. An attempt to create clarity here could be a signpost for a future optimized approach. This attempt will be made in the context of this forum.
The Forum is also about time saving qualification activities. Suppliers are an important factor in this modern approach. And therefore the ECA has developed a "Good Practice Guide Qualification and Validation - a guide to effective qualification based on Customer – Supplier Partnership”.
The speakers are team members or reviewers of the guide. So you have the opportunity to discuss the contents, technical aspects of the guidance document, its scope and practical application during Q&A sessions and a survey. All delegates will receive a copy of the current version free of charge as download. Case studies explain how to work together with suppliers. At a red thread the forum shows that based on knowledge management the risk assessments lead to URSes and further qualification activities. And then GEP interacts with the qualification activities. One lecture focuses on Artificial Intelligence and two cases studies show modern approaches like Lean VMP and Fleet Management. Especially for suppliers a “Pixi”-Booklet is developed from the group and will be presented.
Background
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 further developed their Good Practice Guide Qualification and Validation. This guide is supposed to assist pharmaceutical companies and suppliers with how to qualify equipment in a lean way.
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 further developed their Good Practice Guide Qualification and Validation. This guide is supposed to assist pharmaceutical companies and suppliers with how to qualify equipment in a lean way.
Programm
Introduction to ECA´s Good Practice Guide Qualification and Validation
- Development of ECA´s Qualification and Validation Good Practice Guide
- Overview of Version 3.0
Knowledge Management in Validation Life Cycle: Inspector´s Expectations
- What does Knowledge Management mean in GMP environment
- Toolbox for management
- Which data are essential?
- Focus: Qualification & Validation
- How to assure lifecycle performance
GEP – the Basis for a Qualification
- Basic Engineering Workflows (CD, BD, DD – EPCMQ Projects)
- Process-, Equipment Engineers and more (the full picture)
- Key Documents in Engineering Processes
- FAT, SAT and Commissioning
- How a supplier can support qualification
- Typical pitfalls?
Evolution of the Qualification and Validation Practices since its Inception
- General Qualification & Validation History
- First realization in the XX Century
- The US and EU guidances
- the FDA 1983, 1987 and 2011 guides
- the PIC/S Basis
- the EU Annex 15, 2001
- the new Annex 15 is coming
- Separation of the Qualification & Validation tasks - Dispatching of the Qualification & Validation roles: OEM, Industry, Consultants
- Conclusion: Extension of the scope and extension of the qualificators/validators
AI – “Prompt”: Artificial Intelligence, qualify yourself! – Or How Else?
- Differences from conventional software or conventional computer-based systems
- The auditor and (draft) Annex 22 of the EU GMP Guide
- What is different from “normal” data management regarding data integrity? -Qualification/Validation as usual?
- What about the responsibility for AI results?
- How to control the AI Approaches?
Survey for the further Development of the Guide
- Feedback from delegates
- What to improve?
User Requirement Specification: The Biggest Risk - or the Greatest Opportunity?
- The Fundamental Goals of a URS — More Than Just Paperwork
- Between Bestselling Novel and Critical Project Definition: The Intention of a URS
- Lean URS: Minimalist, Focused, Powerful
- Using AI as Co-Author: Smart Support or Risky Shortcut?
“Pixi-Booklet“ – an Easy Way to Share Qualification Information with Suppliers
- What is meant with “Pixi-Booklet”?
- Why a Pixi-Booklet for ECA´s Good Practice Guide Qualification and Validation?
- Example of a draft “Pixi-Booklet”
Case Study:
Lean VMP for Qualification and Validation
Lean VMP for Qualification and Validation
- Continuous Process Verification vs. Classical Approach
- Virtual VMP
- Jidoka-Approach for IPC – is it possible to automate revalidation?
Fleet Management – A New Streamlining Concept for Qualification?
- Primary Definitions
- Proposed Framework for Distributed Manufacturing
- Fleet Management
- Potential Benefits
- A centralised PQS
- Knowledge Management in a Fleet
- Examples out of practice
Weitere Informationen
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Contacts
Questions regarding Content:
Mr Sven Pommeranz, +49 (0) 6221 84 44 47, pommeranz@concept-heidelberg.de
Questions regarding organisation:
Ms Julia Grimmer, +49 (0) 6221 84 44 44, julia.grimmer@concept-heidelberg.de
Recording from 18/19 November 2025
Duration of Recording: 06 h 57 min
Teilnahmegebühr
| ECA-Member*: | € 1690,- |
| Regular Fee*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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