Lean Equipment Qualification - Online Training Recording
Course No. 20706A
Speakers
Ralf Gengenbach
gempex
Rafael Leandro de Souza
NNE Pharmaplan
Dr. Alexander Sterchi
Industrial Engineering
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
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. 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.
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.
Recording from 13 December 2022 Duration of Recording: approx. 2h 13min
Testimonials