Quality Risk Management

4/5 September 2024, Munich, Germany

Course No. 21216

header-image

Speakers

Christof Langer

Christof Langer

OSConsulting

Aidan Madden

Aidan Madden

FivePharma

Dr. Franz Schönfeld

Dr. Franz Schönfeld

Regierung von Oberfranken

Alexandra Bauloye

Alexandra Bauloye

GSK

Objectives

This ECA training course deals with the practical implementation of Quality Risk Management (QRM). You will learn how to implement and use QRM approaches to increase efficiency and to meet the expectations of the regulators.

Background

The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH). To achieve the quality objective, “there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice, Quality Control and Quality Risk Management.” [EU-GMP Guidelines, Part 1, Chapter 1].

QRM was formally introduced to the pharmaceutical industry with the ICH Q9 Guideline, which has been incorporated in the EU-GMP Guidelines, Part 3. In the course of implementing ICH Q9, risk-based approaches increasingly gained in importance. Before that, it was often the case that processes were defined, implemented and documented to the latest detail. Now, based on risk assessments, more flexibility is possible, allowing implementing and controlling processes more efficiently. Decisions can be made based on evaluated risks. Unfortunately, many companies limit their whole QRM system to the implementation of the FMEA method only. But it is much more than this and QRM can support the pharmaceutical industry in improving their processes and performance.

Target Group

This training course is designed for members of staff in pharmaceutical, biopharmaceutical and API industry’s production and quality units, who establish, manage and use quality risk management systems.

Programme

Quality Risk Management

Seminar Programme as PDF

ICH Q 9 - Quality Risk Management: an Overview
  • QRM in non-GxP industries
  • QRM in pharma
  • Historical GMP Situation
  • ICH Q9: current Revision
  • QRM tools and techniques
The Inspector’s View
  • Expectations
  • Integration in the Pharmaceutical Quality System
  • Examples for good and not so good practice
How to realise Quality Risk Management in a GMP Environment
  • The term “quality risk management” is used throughout the GMP guidelines. In this session you will get some practical advice on how implement QRM
  • SOPs needed
  • Auditing
Interactive Session: Applying Principles of QMR after an Incident has happened
A problem has occurred – how to perform a sound Risk Assessment of the situation and come to an appropriate decision.

Design of an Event Handling System based on a Quality System and Quality Risk Management Approach
  • QRM in the Quality System
  • Design of an Event Handling system based on QRM and Management Review
  • Use of QRM in the evaluation of Events
  • Examples
Case Study: Quality Risk Register
  • What is it, how to develop it and which type of risks to include
  • What to show to authorities?
  • The way to business continuity
  • Examples
How to implement Quality Risk Management in a pharmaceutical Company
  • Part 1: QRM Tools made practicable in daily life
    - ICH Q9 and other Norms (with takeaways for Pharma)
    - Strength of practical DMAIC methodology
    - QRM culture: principles and examples
    - Cost of Quality/Compliance
  • Part 2: Examples
    - Change Control
    - Monitoring
    - Maintenance

stop

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
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

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

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“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.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

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

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023