Effective Equipment Qualification according to Annex 15 - Online Training Recording

Costs

*ECA-Member:**	EUR 790,--
*Regular Fee:**	EUR 990,--
*EU/GMP Inspectorates:**	EUR 495,--
*APIC Member Discount:**	EUR 890,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Eva Baumgartner, Syntacoll
Dr Berthold Düthorn, Syntegon
Ralf Gengenbach, gempex
Gert Moelgaard, Moelgaard Consulting
Rafael de Souza, Pharmaplan

Objectives

A team of pharmaceutical companies, engineering companies and suppliers have developed ECA´s Integrated Qualification and Validation Guide over 3 years. Since autumn 2020 the version 1.0 is available. The key for a successful 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 retesting. This is one of the core concepts in the guide . With this course the practical “how to do” will be explained with “real-life” case studies.

Background

Almost 30 years after the coming into force oft he 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 extend the time limits again. 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 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 revision and FDA Process Validation Guidance regarding Qualification/Verification and Process Validation activities and want to see how the guide can be implemented in practice.

Technical Details:

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.

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

Development of ECA´s Integration and Validation guideline
Main content
Comparision to other qualification guides

How suppliers work: Good Engineering Practice in 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?

Cooperation between customers and suppliers on Integrated Qualification and Validation

Importance of Project Quality Plan (PQP) as upfront clarification document
Agreement of scope of supply and services – task for both contractual partners
Technical documentation, Test documentation and execution - the effect of work-shops for common understanding and agreement
Importance of Qualification Project Management - Collaboration spirit as key success factor

ECA Q&V Guide and tools: Risk-based qualification from URS to PQ

Critical Aspects Risk Assessment (CARA) and its 3 steps
Interface between Product and process requirements (PPURS) and URS
CARA and the “red thread” of user requirements
Support C&Q tools: Use of Test Matrix (TM) and Requirements Traceability Matrix (RTM) from DQ to PQ

ECA Q&V Case Study: Fast and effective project execution with suppliers

International standard, common language with suppliers
Using the best ideas in our company
Categories of equipment: benefit during qualification
What would we expect from our suppliers?
Integrated Qualification and Validation from a pharma perspective

Recording from 08 June 2021
Duration of the recording: approx. 04 h 05

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