- GAMP (MEL-31-07-19)
9:00 am - 4:00 pm
Melbourne 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 Phone: +61 3 9878 4111
Venue Website: http://www.clariononcanterbury.com.au/Address:
Welcome to the Canterbury International Hotel
The Canterbury International Hotel is located in Melbourne’s south eastern suburbs only 20 minutes from the CBD and less than an hour from Melbourne airport.
This venue boasts 72 luxurious rooms for international and interstate attendees who require accommodation. Dining options include the on-site restaurant and relaxed atrium.
Wireless internet access is available.
Car-parking is available on-site.
City Information: Melbourne, Victoria
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