How to Audit Sterile Products Manufacture
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Improving Your Auditing Skills, The How To Audit Series
Dates:
Friday 09 October 2025
Venue:
Amsterdam Marriott Hotel, Amsterdam, The Netherlands
Cost:
£735.00 excl. VAT or £882.00 incl. VAT
(2nd delegate bookings from the same company and same site will receive a 20% discount on the course fee)
Type: Pharmaceutical
About this course
The manufacture of sterile products is perhaps the most hazardous of all pharmaceutical production activities – failures can and sometimes do result in patient harm and death. That is why auditing of sterile filling operations is essential and why it is important that the auditor has the right knowledge and experience to conduct the audit with skill and professionalism.
This short, focused course is designed to help auditors with little or no direct experience of auditing sterile filling operations to know where the risks lie, what questions to ask and how to assess whether or not processes are under control.
Course outline
- What makes sterile products special
- An overview of relevant GMP guidance
- The quality critical steps in sterile filling and how to ensure these are under control
- How to plan an audit of sterile filling
- How to assess the effectiveness of environmental monitoring programmes
- The key questions to ask
- What answers to expect!
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
www.marriott.com
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
“Good level of information with expert guidelines for good auditing practice.”
Adam Elliott CP Pharmaceuticals (Wockhardt), UK
“This course has reaffirmed knowledge that I already had about sterile manufacturing and has given me confidence to be able to conduct relevant and effective audits.”
Sarah Kelly, CP Pharmaceuticals (Wockhardt), UK
“Excellent course, good balance of lectures and group based tasks.”
Stephen Weetman, CP Pharmaceuticals (Wockhardt), UK
“Good, precise summary of important innovations for sterile auditing.”
James McCraken, Amdipharm Mercury, UK
“Excellent insight into auditing sterile operations, this has increased my confidence greatly.”
Waqar Mirza Pharmaserve, UK
“Gave a good brush up for auditing sterile manufacturers, without using more than a day.”
Henric Larsson, Takeda Pharma, Denmark
An NSF International Company 
