- GAMP (ADE-29-06-18)
9:00 am - 4:00 pm
Adelaide GAMP & Computerised Systems Validation Training Course
This training course on how to validate computerised systems covers the essential principles on how to use a risk-based approach in Computer Systems Validation (CSV).
The course provides a broad overview of GMP requirements for computerised systems and is designed for professionals seeking training on a practical and cost effective approach. We will cover the risk-based approach and a detailed overview of various CSV methodologies including those based on the ISPE Good Automated Manufacturing Practice (GAMP®5) guidance, the waterfall and V models, all meeting EU GMP & PIC/S PE 009 Annex 11 and the US FDA 21 CFR Part 11.
“There are major business benefits in having a defined process that delivers systems that are fit for intended use, on time, and within budget. Systems that are well defined and specified are easier to support and maintain, resulting in less downtime and lower maintenance costs…”
ISPE GAMP® 5 “A Risk-Based Approach to Compliant GxP Computerized Systems”
We regularly offer GAMP/CSV training courses and events in Adelaide, Auckland, Brisbane, Hong Kong, Melbourne, Perth and Sydney, or in other countries on as needed basis.
Venue: The Lion Hotel - Adelaide
The Lion Hotel
Located in picturesque North Adelaide and less than 25 minutes from the airport, The Lion Hotel is a stunning heritage listed building from the 1880’s, with a thoroughly modern, contemporary and sophisticated interior.
North Adelaide provides a range of accommodation options to suit a wide variety of budgets and tastes.
Adelaide is South Australia’s cosmopolitan coastal capital. Its ring of parkland on the River Torrens is home to renowned museums such as the Art Gallery of South Australia, displaying expansive collections including noted Indigenous art, and the South Australian Museum, devoted to natural history.