How to Audit - Manufacture and Control of Investigational Medicinal Products
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Improving Your Auditing Skills, The How To Audit Series
Dates: Tuesday 04 June 2025
Venue:
York Marriott Hotel, York, UK
Cost:
£700.00 excl VAT – £840.00 inc VAT
Type: Pharmaceutical
About this course
Whilst the manufacture and control of clinical supplies (investigational medicinal products) is in many ways very similar to the production of commercial products, there are important differences. These relate to scale of manufacture, blinding of studies and application of conventional GMP principles, which make auditing of these activities complicated and which require special understanding.
This short course is designed to help auditors with little or no direct experience of IMP manufacture to understand the special risks and to carry out an audit with skill and professionalism.
Course outline
- What makes the manufacture and control of IMPs so different?
- An overview of relevant GMP guidance
- An overview of key processing steps in the manufacture, packaging and control of IMPs, with particular emphasis on the quality critical steps
- How the clinical trial phases affect GMP expectations
- How to plan an audit of IMP manufacture
- The key questions to ask
- What answers to expect!
At the end of this one-day course you will have had practice in:
- Deciding what should be the focus of your audit in an IMP operation
- Developing an audit plan for an IMP facility
- Developing aide-mémoires that ensure you don’t forget the important things
- Classifying audit observations and assessing the level of risks
Venue
York Marriott Hotel, York, UK
The York Marriott Hotel is within walking distance of York city centre and its many attractions. With 151 stylish guest bedrooms the hotel is ideal for the business or social traveller.
Secure WIFI internet access is available in public areas and their recently refurbished Leisure Club features a heated pool, sauna, steam room, jacuzzi, gymnasium and private tennis court.
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 are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- 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
York Marriott Hotel
Tadcaster Road
York
YO24 1QQ
England
Tel: +44 (0) 1904 701 000
Fax: +44 (0) 1904 702 308
Hotel Bookings
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link
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:
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