Practical Application of Quality Risk Management
About this Course
Risk management has become the latest hot topic in pharmaceutical quality, regulatory inspection prioritization and also in the field of Pharmacovigilance and post-marketing drug safety surveillance.
The ICH Q9 guideline on ‘Quality Risk Management’ was approved in November 2005 and has been implemented in the EU, Japan and USA. It is Annex 20 of the EU GMP Guide.
You are already making risk-based decisions every day! This course is designed to assist you in understanding exactly what formal Quality Risk Management is, how to implement it and provide you with the skills to make the right decisions; this will add value to your business and meet the developing regulatory expectations. It will help you move away from ‘firefighting’ to proactively manage risks.
The background and content of ICH Q9 will be explained by a member of the Expert Work Group who drafted the guideline.
Industry experts will explain how Quality Risk Management can be used in real life, practical situations.
What You Will Learn
1. What is in ICH Q9/EU Annex 20 and how it can be used to improve business performance
2. How to decide on the appropriate level of Quality Risk Management
3. A structured Quality Risk Management process and how it can be applied to a wide range of situations
4.The most common Risk Assessment techniques (e.g. Risk Ranking, FMEA and HACCP) and how they may be used in a pharmaceutical context
5.How to document Quality Risk Management in a way that will add value to your business and meet regulatory expectations
6. How leading practitioners are already using Quality Risk Management in the pharmaceutical industry
An 3-day course exploring the background to the new science and risk-based regulatory paradigm: 1. ICHQ8 Pharmaceutical Development 2. ICH Q10 on Pharmaceutical Quality Systems 3. ICH Q9 Guideline on Quality Risk Management What it says and what it means 4. A detailed quality risk management process, based on ICH Q9/EU Annex 20
· How to implement it
· How to integrate with existing Quality Management Systems
The key focus will be on how to apply risk management tools and techniques in a variety of pharmaceutical situations such as:
· Validation planning
· Complaints, deviations and troubleshooting
· Audit planning and preparation
· Microbial and cross contamination control
· Supplier and contractor management
· Documentation design and control
· Planning preventative maintenance
· Day-to-day decision making