How to Audit - IMP GMP Operations
Print
Improving Your Auditing Skills, The How To Audit Series, New for 2012
Tuesday 29 May 2025
York Marriott Hotel, York, UK
£495.00 excl VAT – £594.00 inc VAT
Type: Pharmaceutical
About this course
The reliability and integrity of the data coming out of a clinical trial depends on the quality of the Investigational Medicinal Products (IMPs) being correct. The manufacture, packaging and distribution of IMPs may seem straightforward to those in the commercial world but there are unique challenges and differences that must be understood by the auditor in order to assess patient risk and compliance with EU GMP and, in particular, Annex 13.
Auditors cannot conduct effective audits of IMP operations unless they understand the challenges presented by manufacturing and packing IMPs and are trained in the specific GMP and Regulatory issues that make IMPs unique.
It is a challenge for the industry and for auditors to know where GMP audits end and where GCP audits begin. In fact there is no clear dividing line. There is a great deal of overlap between GMP and GCP and this needs to be understood.
Auditors faced with performing their own internal audits or audits of contractors handling IMPs have many questions:
- What are the key differences between commercial operations and IMP operations?
- How do I know what is the correct approach to auditing IMP facilities?
- How do I assess the significance of any findings?
- How much do I need to know about the IMP itself?
- Do I need to know about GCP?
This one-day course will attempt to answer all of these questions in a practical way so that delegates have materials they can use in their IMP auditing work.
Course outline
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 including the National Railway Museum and
York Minster. Castle Howard, the Yorkshire Dales and the North
Yorkshire Moors are within a 1 hour drive of the hotel. With 151
stylish guest bedrooms the hotel is ideal for the business or social traveller.
The hotel offers a range of banqueting rooms holding up to 190 delegates theatre style, secure WIFI internet access is available in public areas and our recently refurbished Leisure Club features a heated pool, sauna, steam room, Jacuzzi, gymnasium & private tennis court.
The all new Chase Bar & Grill serves a varied menu and offers a wide
choice of refreshments whilst offering unrivalled views of York
Racecourse from its sun terrace. The York Marriott’s recent accolades
include retaining the BDRC Best Conference Venue in Yorkshire
Award for 2008 (for the 3rd year in succession), as well as winning
the highly coveted York Tourism Bureau Award for Hotel of the
Year 2009.
Hotel Accommodation
- We have a block booking of bedrooms at the York Marriott Hotel, at a specially negotiated bed and breakfast rate per delegate per night.
- As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions (issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel. 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:
What you've said
New Course – No Testimonials Available
An NSF International Company
