Lean Equipment Qualification - Live Online Training
Tuesday, 13 December 2022 13.00 - 16.45 h
Course No. 20706
Speakers
Dr. Alexander Sterchi
Industrial Engineering
All times mentioned are CET.
Objectives
A team out of pharmaceutical companies, engineering companies and suppliers have developed ECA´s Integrated Qualification and Validation Good Practice Guide (GPG) over 4 years. Version 2.2 is published in autumn 2022. The key for a successful equipment qualification project is the “hand-in-hand” work from suppliers and customers together. With the integration of Good Engineering Practice (GEP) into qualification activities GEP-tests can be used also for the qualification phases – without repeated testing. This is one of the core concepts in the guide and benefit for the industry. With this course the practical “how to do” will be explained with “real-life” case studies.
Background
Thirty years after the coming into force of the EU GMP Guide in 1992 equipment qualification is still often a miracle. Qualification projects overrun scheduled time limits. Failures are discovered in the IQ and OQ exercises. To fix this and the deviation reports the time limits again have been extended. A non-harmonized terminology causes one of the main problems, especially when it comes to the integration of good engineering practice into qualification. But on the other side is the integration of good engineering practice activities a key factor for qualification in fast-track projects. How can this come together? This is the content of ECA´s Integrated Qualification and Validation Guide.
Target Group
Everyone who may be influenced by the Annex 15 of the EU GMP Guide and FDA Process Validation Guidance regarding equipment qualification activities and want to see how the guide can be implemented in practice.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
Overview: Integrated Qualification and Validation: Good Practice Guide from ECA Ralf Gengenbach
History of Qualification
Why a new guideline?
Main content and structure
Comparison to other qualification guides
The team behind
OM Pharma: Harvest Tank Case Study Rafael de Souza & Aurélie Di Giovanni-Charpy
Project introduction
Lifecycle documents (QRA and URS)
Cooperation supplier – customer
Pros and Challenges
Next steps
Case Study Canexis Pharma: Risk-based Lean Facility Qualification for a Cannabis Production Building Dr Alexander Sterchi & Sebastian Zeller
Lean, risk-based and integrated facility qualification
Efficient collaboration between operations, facility design/construction and qualification experts
Holistic support for facility design, utilization and operations
Controlled environments for Cannabis extraction and isolation of compounds
Combination of GMP and GACP requirements in one common building
Integrated Qualification and Validation Guide
All participants of this course can download the new version 2.2 of the guide free of charge.
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