Ralf Gengenbach
gempex
Referent:innen
Klaus Eichmüller
EU Inspector
Maik Guttzeit
Bayer
Pia Loris
Drees & Sommer
Rafael Leandro de Souza
NNE Pharmaplan
Dr. Clemens Borkenstein
ZETA
Igor Krasula
Valicare
Rolf Bauer
Syntegon
Dominik Unglaub
gempex
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 although a risk-based approach has been a regulatory expectation for years. Also many companies have very little integration between their activities and supplier´s activities, so the overall qualification and validation effort is complicated, expensive and time-consuming. Only few companies have leveraged their qualification and validation programs to a fully integrated approach, as the EU Annex 15 and the FDA Process Validation guide emphasizes.
This Forum is about time saving qualification and validation activities, where suppliers are an important factor in this modern approach.
A team of pharmaceutical companies, engineering companies and suppliers have developed and further optimized ECA`s Good Practice Guide “Integrated Qualification and Validation – a guide to effective qualification and validation based on Customer – Supplier Partnership”. The guide considers feedbacks from regulators, the pharmaceutical industry and suppliers as well as practical experiences from real project cases. In this updated 3.0 version, there are new examples to make the process on “how-to-do” the critical aspects risk assessments (CARA) easier to understand, improvements on illustration of video-assisted FAT/SAT, as well as some new aspects in equipment categorization. It is the endeavor of the expert team to keep the guide always up to date with the latest knowledge through newly gained experiences.
The experts working on this guide will be present and so participants will have the opportunity to hear first-hand and to discuss the contents and technical aspects of the guidance document, its scope and practical application. Case studies are presented to help better understand the content of the guide and its implementation. All delegates will receive the possibility to download the current guide free of charge. Case studies explain how to work together with suppliers and how to use an integrated Approach.
Hintergrund
Qualification of equipment and validation 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 a Good Practice Guide on Modern Qualification to Integrated Qualification and Validation. This guide is supposed to assist pharmaceutical companies and suppliers with how to qualify equipment in a lean way and how to integrate the qualification into validation? Like in the GAMP-Guide, examples build the core of this further developed Good Practice Guide on Qualification and Validation.
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.
ECA´s Integrated Qualification and Validation Guide
All delegates will receive the current version 3.0 of ECA´s Qualification and Validation Guide.
Programm
Gesamtes Programm als PDF herunterladen
Welcome and Introduction to Qualification and Validation
Ralf Gengenbach
Ralf Gengenbach
- Development of ECA´s Integration and Validation Guideline until version 2.2
- What is new?
Modern Qualification and Validation from an EU Inspector's View on Current Approach
Klaus Eichmüller
Klaus Eichmüller
- Overview regulatory requirements
- Changes in Annex 15 for qualification activities
- In between: Cleaning Validation
- Process validation: Expections and weakness
- Perspective
Comparison of Equipment Qualification Guidelines – which one for which Purposes?
Ralf Gengenbach
Ralf Gengenbach
- What is on the market regarding equipment qualification?
- What is mandatory and what is optional?
- How far are those guidelines and standards harmonized?
- Are there different guidelines for different purposes?
Update Critical Aspects Risk Assessment (CARA) Chapter
Rafael de Souza
Rafael de Souza
- The CARA concept in the equipment qualification life cycle
- Comparison between Quality Risk Management and CARA
Video-assisted FAT/SAT – The Update in the Guide
Rolf Bauer & Dr Clemens Borkenstein
Rolf Bauer & Dr Clemens Borkenstein
- Definition, considerations and limits regarding remote testing
- Collaboration and alignment of equipment manufacturer and customer
- Checklist for preparations before / during and after a remote FAT
- Documentation of results and handling of deviations
- Show case project for remote test execution including “best of” video sequences
- What is new in this chapter
Update Equipment Categorisation – a Tool to streamline Qualification
Maik Guttzeit
Maik Guttzeit
- Regulatory possibilities for using qualification approaches, which are adapted to relate Risk
- The revised categorization chapter, what is new?
- New appendix: template equipment qualification
- Examples
- What is new in the guide?
Electronic Documentation in Qualification Projects
Igor Krasula
Igor Krasula
- Requirements for electronic documentation in qualification
- Requirements related to Data Integrity
- The ALCOA principle
- Case study
Strategies to plan Qualification Activities in Life Science Projects
Pia Loris
Pia Loris
- Qualification requirements in project plans
- GMP Qualification Requirements in Life Science Projects
- Potential Sources of Error during GMP Qualification
- Optimization of GMP Qualification Activities
- Examples
Audit and Inspection Findings regarding Equipment Qualification
Dominik Unglaub
Dominik Unglaub
- How deep is inspector's diving into the qualification topic?
- Which basic logic do they follow and which guidelines?
- Overview about some real inspection findings
Feedback to the Integrated Qualification and Validation Guide
Ralf Gengenbach
Ralf Gengenbach
- Open Questions
- Outlook
Tutorial Workshop
Panel discussions about the possibilities of ArtificialIntelligence in qualification Projects.
Panel discussions about the possibilities of ArtificialIntelligence in qualification Projects.
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Validation Manager"
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