Computer Validation - Latest Requirements
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IT professionals and engineers develop, manage, maintain and support the systems upon which GMP records, necessary for making critical decisions are created and maintained.
Tuesday 11 September 2025
York Marriott Hotel, York, UK
£495.00 excl VAT – £594.00 incl VAT
Type: Pharmaceutical
About this course
IT professionals and engineers develop, manage, maintain and support the systems upon which GMP records, necessary for making critical decisions are created and maintained, eg batch records, laboratory data and recall systems.
So understanding the regulatory expectations for GMP records, particularly the newly released Annex 11 on Computerised Systems from the IT, engineering and QA perspective, is essential.
Who Should Attend
- Personnel who work in IT or systems support for GMP applications and who have to understand and comply with GMP and other similar regulations
- Engineers working with control systems in GxP areas
- Quality Assurance personnel, particularly Qualified Persons, who have to know the records that they review have integrity
- Personnel who are involved in the auditing of IT systems, operations and services
Course outline
This course will describe the new Annex 11 Guidance on Computerised Systems and help delegates:
- Identification of the impact of the changes
- To identify and resolve any gaps between their current operations and the newly announced expectations
- Benchmarking current operations against the new Annex for compliance
- European expectations on electronic records and signatures
- To discuss the latest trends in computer validation
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
“Given a much greater knowledge to be able to go back and fill gaps with current systems and these developments.”
Richard Jopson, Reckitt Benckiser Healthcare
“Provided reassurance in some aspects of CSV and food for thought in several others.”
Gregor McNeil, Vectura
“Excellent discussion sessions, well led course. Has given me much more confidence to go back and implement the requirements.”
Anne Sullivan, Resolution Chemicals
“Valuable and enjoyable.”
Peter Halfpenny, The Co-operative Pharmacy NDC
“Good course content and pace.”
Geoff Adams, Thornton & Ross
An NSF International Company
