Risk-Based Decision Making for Quality Professionals and QPs
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The manufacture of medicines is easy – until something goes wrong.
Dates: Tuesday 05 to Wednesday 06 March 2026
Venue:
Amsterdam Marriott Hotel, Amsterdam, The Netherlands
Cost:
£1400.00 excl. VAT – £1680.00 incl. VAT (if applicable)
Type: Pharmaceutical
About this course
The manufacture of medicines is easy – until something goes wrong.
Important decisions have to be made quickly. These are rarely simple. There is never enough time, and important data and information is usually in short supply. To protect your patients and your reputation your decisions must be:
- Scientifically justified
- Based on an objective and realistic assessment of RISK
- In compliance with regulatory requirements and expectations
- GOOD for your business!
This course will provide you with the tools and techniques to make the right risk-based decision no matter how challenging the situation.
This is not a typical course where you are lectured to for hours on end. Most of the course will be spent working in small groups on common problems you face every day.
- Key point lectures will provide you with the most up-to-date information in each subject area
- You will then be given real life problems to solve in small groups. With the help of the tutors you will be asked to solve each one and make a risk-based decision
- It is not what you know that matters. It is what you do with what you know that really matters
This course will improve your ‘root cause’ problem solving and decision making skills no matter what the situation.
Course outline
Risk-Based Decision Making: The Theory
- Practical implementation and use of ICH Q9 ‘Quality Risk Management’
- Good decision making practices
- Failure Mode Effect Analysis (FMEA) and Hazard Analysis Critical Control Point (HACCP)
- Force field analysis, Fishbone diagrams and many more techniques!
Risk-Based Decision Making: The Practice
How to Investigate and Make the Right Risk-Based Decision Relating to:
- Product release: What do you do with the ‘imperfect’ batch? Release or reject?
- Stability test failures
- Product recalls and customer complaints
- Deviations and CAPAs:
- How to assess criticality and identify CAPAs
- How to handle recurrent deviation incidents
- What to do when you can’t find root cause
- How to prevent deviation ‘overload’
- Change controls: When to approve and when to reject
- Validation: How much is enough?
- Procedural non-compliances: How to assess risk and prevent recurrence
- Product bioburden excursions
- Raw materials: Management of out of specification and out of trend results
- Environmental monitoring excursions (viable and non-viable particulates)
- Pharmacopeia water issues – chemical and microbiological
- Utilities: What to do when your water and HVAC systems ‘crash’!
- Engineering: What to do when you have calibration and maintenance failures
- Management and risk assessment of packaging related ‘mix-ups’
- Cross-contamination incidents: What to do when you find the unexpected
- Warehousing and distribution: How do you manage those temperature excursions?
AND MANY MANY MORE!
Venue
Amsterdam Marriott Hotel, Amsterdam, The Netherlands
The Amsterdam Marriott Hotel is among the superior hotels in Amsterdam, it offers an ideal location across from the Leidseplein’s fine shopping, dining and entertainment.
As a guest, you’ll find well appointed guest rooms with high speed internet to keep you in touch. A well equipped fitness room will help keep you in shape. Fine dining awaits in their two restaurants.
Hotel Accommodation
-
Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which will be provided to you on receipt of a completed booking form.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Amsterdam Marriott Hotel
Stadhouderskade 12
Amsterdam, 1054 ES
The Netherlands
Tel: +31 20 607 5555
Fax: +31 20 607 5511
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 experts for this course are:
What you've said
“Course gives good problem analysis skills.”
Rachel Gatt Rutter, Arrow Pharma Malta, Malta
“It was the right mix of presentation and workshop. I’ll definitely recommend this course. My preferred way of learning. Thanks!”
Jobby Kallupurackal, Biogen Idec International, Switzerland
“A quite intensive training session but very well built, with a lot of concrete examples, participation, sharing of knowledge. I got some useful tools which will allow me to support/lead investigation in a better way. Thanks for that.”
Isabelle Salvi, Novartis Pharma Division, Switzerland
“I felt I have gained some useful tools to take back to my workplace.”
John Seager, GE Healthcare, UK
“I was hoping to obtain a specific tool that I can follow when assessing my deviations so as not to miss anything, but you have given me plenty of tools to generate one for myself, that is specific to my company.”
Rachel Schofield, Fujifilm Diosynth Biotechnologies Ltd, UK
“Very useful to manage deviations and complaints. Practical exercises are very good to share experience with other people from other companies.”
Audrey Dunham, Nycomed, Belgium
“Excellent insight into problem solving and assessing risk. Buzz groups challenging, backing up the theory. Great learning environment”
David Harvey, Reckitt Benckiser Healthcare, UK
“The course has helped me to identify and map a clear process for decision making and assessing the risk of a deviation and the risk of the decision made.”
Suzanne Smyth, Janssen-Cilag, Ireland
“Scorecards are a great take away!”
Will Davies, Thermo Fisher, UK
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