The GMP-Compliance Manager - Online Training Recording

Costs

*ECA-Member:**	EUR 1490,--
*Regular Fee:**	EUR 1690,--
*EU/GMP Inspectorates:**	EUR 845,--
*APIC Member Discount:**	EUR 1590,--

(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

Ingo Ebeling, Abbott
Melanie Kinzner, Sandoz
Katja Kotter, Vetter Pharma-Fertigung
Sue Mann, Sue Mann Consultancy

Objectives

During this Live Online Training you will learn how the various pharmaceutical quality and documentation systems work and how they interact. Experts from the pharmaceutical industry will show you possibilities to improve your systems and how to run them efficiently and in compliance with (c)GMP.

Background

Pharmaceutical Quality Assurance and GMP Compliance Managers are continuously facing new challenges due to changing regulatory requirements and at the same time increasing needs for efficiency. In this context, QA and GMP-Compliance Managers must be familiar with many GMP-related aspects and systems like:

Non-Conformance Management
Quality Risk Management
Document and Data Governance
Monitoring and Quality Reports

And these are not stand alone systems. They are all linked to each other: A Deviation causes a Failure Investigation which is followed by a CAPA that can lead to a Change and Change Control. All relevant information must be documented in Quality Reviews and Risk Management is the key to almost everything. And everything should be documented and data handled in an integer way. Companies should have all these systems in place. Let’s find out how we can get the most out of them!

Target Group

This Course is designed for all persons in pharmaceutical, biopharmaceutical and API industry’s production and quality units who establish, manage and improve quality and documentation systems.

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.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:

The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.

Programme

Current Regulatory Developments and their Impact on the Quality Management System

New and relevant EU GMP requirements for the Quality Management System
Challenges and Opportunities

Deviation - Investigation – CAPA

GMP requirements and expectations
Deviation management: best industry practice
Performing Failure Investigation
Elements of investigations
CAPA-System and elements
Success factors for an integrated system
Industry approaches for CAPA systems

Quality Metrics and KPIs

From Data Collection to Continuous Improvement

Data Integrity: what the GMP Compliance Manager needs to know about it

What’s it all about (where does the hype come from)
What you need to know about it
What are inspectors looking for?

Risk Analysis - ICH Q9 and FMEA

The Principles of Risk Analysis
A detailed look at FMEA and HACCP
How to apply ICH Q9 “Quality Risk Management”
Process improvement with Risk Analysis

Documentation Systems and their Compliance with the Marketing Authorisation

Regulatory requirements
Document change management: Maintaining compliance
Records retention
Archiving
How to keep track of raw data/GMP relevant documentation
Language: local language vs. English; quality of translation
Issue/training/effective date vs. new document Version

How to control the Flow of Documents

Review and approval of Documents
Batch Record Review process
GMP process and data flow
Documentation vs. Data integrity issues

Product Quality Review and Annual Product Review as Quality Enhancement Tools

Best practices in combining the two reviews
Statistical background and trending
Timing of PQRs
Responsibilities: who is responsible for generation of particular parts of the report, analysis and final conclusion
Site specific versus product specific PQR
Challenges and recommendations to overcome challenges
Examples and case studies

Case Study: How to monitor Suppliers

Key Quality and Performance Indicators
Reporting and Monitoring (trend analysis and targets)
Who is involved – who is responsible?
Outlook: the FDA Guidance on Quality Metrics

Recording from 03/04 November 2021
Duration of the recording: approx. 9.5 h

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