Live Online Training: The GMP-Compliance Manager

4/5 November 2020

Course No. 18220

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Speakers

Katja Kotter

Katja Kotter

Vetter Pharma-Fertigung

Ingo Ebeling

Ingo Ebeling

Abbott Laboratories

Melanie Kinzner

Melanie Kinzner

Sandoz

Dr. Sue Mann

Dr. 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: ƒ
  • Non-Conformance Management ƒ
  • Quality Risk Management ƒ
  • Document and Data Governance ƒ
  • 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 Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Live Online Training: The GMP-Compliance Manager

Seminar Programme as PDF

Programme
Wednesday, 04 November 2020
 
Welcome and Introduction

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
Q&A Session
 
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
Q&A Session

Programme
Thursday, 05 November 2020

Welcome and Introduction

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
Q&A Session

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

Q&A Session

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This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
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Further dates on-site
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Further dates online
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Recording
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

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“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
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“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
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