About this course
Computer systems and IT underpin the successful operations of all pharmaceutical and associated companies. They are everywhere in our activities and operations and so the potential audit scope is enormous. However, not all aspects of the systems in use in our regulated environment are GxP-relevant, although some are fundamental to the safety and protection of the patient.
It is important to be able to identify the real risks associated with the use of such systems and focus the attention of the auditor in these areas. This course will approach the auditing of computer systems and the IT department from that perspective.
Key questions are:
- What is important from the GxP and compliance perspective about computer systems?
- How should I approach the auditing of computer systems?
- What standards are appropriate?
- How do I audit the IT department?
- How do I assess the significance of any findings?
- Is there anything new in the regulatory trends that I need to consider?
This one-day course will attempt to answer all of these questions in a practical way so that you have materials you can use in your auditing work.
Course outline
An outline of the course is as follows:
- What should be the focus of audits of computer systems?
- Developing an audit plan for different types of computer systems
- Developing a plan to audit for the IT department and IT operations
- Developing aide-mémoires for these audits
- Classifying audit observations
This course is intended for delegates who have attended the NSF-DBA ‘Effective Pharmaceutical Audits and Self-Inspections’ course, and a good knowledge of the basic principles and practices of auditing is assumed.
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. Glen Hove 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
During the course, 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 appetising 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.
Venue Address and Contact Details
Glen Hove Conferencing, 52 Glenhove Road
Melrose Estate, Johannesburg, 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
“Good aide-mémoires”
Stephen Swan, Merck Sharp & Dohme Ltd
“Fine course”
Martin Slavik, Ferring Leciva AS
An NSF International Company
