About this course
Risk management has become the latest hot topic in pharmaceutical quality, regulatory inspection prioritisation 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.
Your tutor will explain how Quality Risk Management can be used in real life, practical situations.
What You Will Learn
- What is in ICH Q9/EU Annex 20 and how it can be used to improve business performance
- How to decide on the appropriate level of Quality Risk Management
- A structured Quality Risk Management process and how it can be applied to a wide range of situations
- The most common Risk Assessment techniques (e.g. Risk Ranking, FMEA and HACCP) and how they may be used in a pharmaceutical context
- How to document Quality Risk Management in a way that will add value to your business and meet regulatory expectations
- How leading practitioners are already using Quality Risk Management in the pharmaceutical industry
Course outline
The background to the new science- and risk-based regulatory paradigm:
- ICH Q8 on Pharmaceutical Development
- ICH Q10 on Pharmaceutical Quality Systems
ICH Q9 Guideline on Quality Risk Management:
- What it says and what it means
- Impact on regulatory expectations
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 other 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
Discussion and Working Groups
A significant proportion of the course will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods including a tutor-led panel session will provide delegates with an opportunity to have their specific questions answered.
Venue
Glen Hove Conferencing, Johannesburg, South Africa
Glen Hove Conferencing is centrally located in Johannesburg and close to the very popular Melrose Arch Complex with its superior hotels and dining facilities. Glen Hove Conferencing is the headquarters of the Southern Gauteng branch of the South African Pharmaceutical Society.
For assistance in finding accommodation please contact the Course Convener, Dr A J Thomas on [email protected]
The courses will be held in the ultra modern Upper Glen Hove meeting room which can comfortably seat 80 persons. Acoustics in the room are excellent as is the standard of catering facilities provided. For further information please visit the conference centre’s own website at www.glenhove.co.za or email them at [email protected]
Catering
During the course, mid-morning tea plus snacks will be served at approximately 10.00 with afternoon tea served at 15.00. At lunchtime you can enjoy an appetising finger buffet served in the foyer.
After each day’s activities a closed bar service will be available, chargeable to your account where relevant.
Special Dietary Requirements
If you have any special dietary requirements, please contact the conference management.
Venue Address and Contact Details
Glen Hove Conferencing, 52 Glenhove Road
Melrose Estate, Johannesburg, 2196
PO Box 2467, Houghton, 2041
Tel: 011 442-3601
Fax: 011 442-3678
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is:
What you've said
What our delegates in Europe have said
“Good course, the teamworks really helped you to understand the different tools and possibilities as well as showing the potential pitfalls you might face when implementing Quality Risk Management in your company.”
Annette van Utteren, Synthon BV, The Netherlands
“Teamworks provided very positive learning by doing; a lot of fruitful discussions both within and outside the classroom. The pragmatic approach, humour included.”
Inger Kvitvang, Pharmaq AS, Norway
“A very good course. It will bring the quality in our company to an even higher level.”
Michael van der Kuylen, Nobilon International BV, The Netherlands
“Good balance between lectures and team exercises.”
Krisztina Aust, GSK Biologicals KTF, Hungary
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