Computer Systems - Requirements
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How compliant are your computer systems?
Tuesday 12 June 2025
Glen Hove Conferencing, Johannesburg, South Africa
R4815.00 (first booking)
R4414.00 (SAAPI Members)*
R3852.00 (additional delegates from same site)*
* delegates are eligible for only one discount type
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.
Therefore, an understanding of 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
- Quality Assurance personnel, particularly Qualified Persons, who have to know the records that they review have integrity
- 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
- 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:
- Identify the impact of the changes
- Identify and resolve any gaps between their current operations and the newly announced expectations
- Benchmark current operations against the new Annex for compliance
- Understand European expectations on electronic records and signatures
- Discuss the latest trends in computer validation
Venue
Glen Hove Conferencing, Johannesburg, South Africa
Glen Hove Conferencing is centrally located in Johannesburg
and close to the very popular Melrose Arch Complex with its
superior hotels and dining facilities. Glenhove Conferencing is
the headquarters of the Southern Gauteng branch of the
South African Pharmaceutical Society.
For assistance in finding accommodation please contact the Course
Convener, Dr A J Thomas on [email protected]
The courses will be held in the ultra modern Upper Glen Hove
meeting room which can comfortably seat 80 persons. Acoustics
in the room are excellent as is the standard of catering facilities
provided. For further information please visit the conference centre’s
own website at www.glenhove.co.za or email them at [email protected]
Catering:
On each of the course days, mid-morning tea plus snacks will be served at approximately 10.00 with afternoon tea served at 15.00. At lunchtime you can enjoy an appetizing finger buffet served in the foyer.
After each day’s activities a closed bar service will be available, chargeable to your account where relevant.
Special Dietary Requirements:
If you have any special dietary requirements, please contact the conference management at:
52 Glenhove Road
Melrose Estate
2196
PO Box 2467. Houghton, 2041
Tel: 011 442-3601
Fax: 011 442-3678
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
What a previous delegate has said about our European Computer Validation course:
“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
An NSF International Company
