About this course
It is a legal requirement that all staff receive regular training in Good Manufacturing Practice.
This course is designed to provide you with up-to-date knowledge of new and impending GMP regulations and current ‘hot topics’.
Europe’s Most Popular GMP Course!
- In the last eight years, over 1000 delegates from all over Europe have attended this very popular course
- This course repeatedly achieves the highest customer satisfaction level of any of our courses, with 95% of delegates rating it “very good” or “excellent”
- This course now forms an entry level GMP training requirement for our very popular Pharmaceutical Quality Management Systems Auditor/Lead Auditor Training Programme
Course outline
Why we have GMP
EudraLex Volume 4
- Structure
- Content
- Application
A clear comparison of EU and FDA GMP requirements
- Areas of agreement
- Critical differences
Up-to-the-minute information on new GMP initiatives and regulations
- FDA’s cGMP for the twenty-first century
- Changes to EU GMP regulations…
- Product quality review
- Ongoing stability testing – reference samples and retention samples
- ICH Q9: Quality Risk Management
Practical advice on dealing with the ‘difficult areas’ of GMP
- Change control
- Deviations
- Assessing the effectiveness of training
An understanding of how GMP is influenced by…
- Premises
- Processes
- Products
- Procedures
- People
An appreciation of the critical GMP issues for…
- Solid dosage forms
- Sterile products
- Liquids/semi-solids
- Packing operations
- Computers
A panel discussion session to explore YOUR specific GMP problems
An Ideal Mix of Lectures. Discussions and Team Tasks
Like all NSF-DBA courses, this course will provide ample opportunity for discussion and debate. Teamwork exercises will encourage participation and reinforce the messages of lectures and tutorials. Delegates will learn from each other as well as from the tutors and will definitely feel ‘involved’ in the learning process!
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
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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.
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:
Invited guest speaker
What you've said
“Complete overview on GMP – that was what I was looking for. Regained my motivation to continue working in QA.”
Markus Schoester, Novartis Pharma, Switzerland
“Excellent course.”
Hazel Dainty, Shire Pharmaceuticals, UK
“An excellent course delivered in a memorable way. I shall certainly be recommending NSF-DBA to others in the industry and shall be attending other NSF-DBA courses in the future.”
Gina Collier, Reckitt Benckiser Healthcare, UK
“Coming from a GMP background I found the course a very good introduction to GMP. I found the tutors very engaging and made the whole course fun to be part of.”
David Conlon, Celerion, UK
“Excellent course to get a complete overview of all GMP aspects! Special compliments to tutors for how they keep our attention during those days! Good balance of theory and day to day examples.”
Janet Wonink, Organon, The Netherlands
“Very good course, obviously amount of content is reliant on amount of time available. Tutors allowed enough time for questions and were very approachable. They had extensive knowledge. This course is very suitable for everyone who has an active role within a GMP environment, even suppliers to the GMP companies.”
Kelly Lindsay-Jermey, Sanofi-Aventis Pharma, UK
“Superb, enjoyable and expertly delivered. Many thanks.”
Doug Strachan, Emcor, UK
“The standard of lecturers/presenters was excellent, very impressed with the quality and completeness of the material covered.”
Gerrard Kemmy, Covidien, Republic of Ireland
“Really great tutors answering all our questions. Absolutely nice mix of lectures and buzz group working. The course had great content (for starters) and was very well presented.”
Hans-Juergen Franke, B Braun Medical, Switzerland
“It is a fun and relaxed way of knowing much more about GMP.”
Elma Snijder, Solvay, The Netherlands
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