Quality Risk Management for ATMP and Pharmaceutical Industry

Quality Risk Management

Special offer for Flemingsberg Business Community members.
15% discount using the registration code: ISF250403


Course description

Quality Risk Management (QRM) is an area that has become increasingly important in the pharmaceutical industry and where expectations regarding a risk-based approach have increased increasingly from the authorities. In this basic quality risk management course, you will be introduced to important basic concepts and also introduced to some of the tools that are commonly used.

However, the focus is on understanding why it is important and value-creating to work in a risk-based way and to highlight how this is used in the pharmaceutical industry and what is important to do this successfully.

The course is largely based on the risk management flow described in ICH Q9 where each part of it is reviewed to identify and discuss difficulties you may encounter in the different steps and how to best work to overcome them.

Contents

  1. Basic regulatory requirements
  2. Basic concepts
  3. ICH Q9 – identifying, assessing, evaluating, controlling, reviewing and communicating risk
  4. Introduction to some common tools
  5. Examples of risk management as part of the quality system
  6. A number of exercises to exemplify and practice a number of different elements that are discussed during the course

Learning objectives

Participants will:

  1. understand the value of working risk-based
  2.  know basic concepts
  3. know the most commonly used tools
  4. understand how to identify, assess, evaluate and manage potential risks effectively
  5. understand how a risk-based approach can be implemented (or already implemented) in your own quality system.

Who should attend

The course is aimed at those who work in or close to pharmaceutical manufacturing and need an introduction to a risk-based approach. Perhaps you often participate in such work and need a greater understanding of what factors are important for success. Or you work overall within the organization, perhaps as a manager, and need to understand the concepts, what requirements exist and what is important for you as an organization to succeed with your quality risk work in an efficient and value-creating way.

#5120F

 740.00

No. persons
Discount:
Members of the Flemingsberg Business Community: 15% discount (Use discount code in invitation)
Date & Time
April 3, 2025
9.00-17.00 CET
IndustryPharmaceuticals
LanguageEnglish
LevelBasic
LocationHuddinge - Stockholm, Sweden
RegionEU/US
VenueInnovation Station Flemingsberg, Huddinge
YOUR INSTRUCTOR(S)​

Marika Lundin

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