Computer Validation - Latest Requirements

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. 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:

• Dr Allan Thomas
  Partner
  Dip.Pharm, MPharm, DPharm, MPS(SA), MPD(IMD), CHE(NWU)

  • [email protected]
  • +27 (0) 21 558 4515
• Ms Anna Naidoo
  Consultant
  Chemist

  • [email protected]
  • +27 (0) 21 558 4515

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

“Provided reassurance in some aspects of CSV and food for thought in several others.”

Gregor McNeil, Vectura, UK

“Excellent discussion sessions, well led course. Have given me much more confidence to go back and implement the requirements.”

Anne Sullivan, Resolution Chemicals, UK

“Valuable and enjoyable!”

Peter Halfpenny, The Co-operative Pharmacy NDC, UK

“Good course content and pace.”

Geoff Adams, Thornton & Ross, UK