- GAMP (BNE-12-11-20)
9:00 am - 4:00 pm
Melbourne GAMP & Computerised Systems Validation Training
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”
Venue: Novotel Brisbane
Venue Phone: +61 7 3309 3309
Venue Website: http://www.novotelbrisbane.com.au/Address:
Novotel Brisbane is located in the heart of Brisbane CBD within walking distance of the Queen Street Mall and the Riverside boardwalk. The conference rooms are equipped with modern audiovisual facilities and filled with natural light.
Each conference room is equipped with ISDN lines and wireless Internet.
Valet Parking and under cover self parking are available at the Novotel Brisbane for a fee.
The Novotel Brisbane is conveniently located near to the Central Railway station.
City information: Brisbane
Brisbane is the capital of Queensland, set on the Brisbane River. Clustered in its South Bank cultural precinct are institutions including Queensland Museum, Sciencentre and Queensland Gallery of Modern Art. Looming over the city is Mt. Coot-tha, site of sprawling Brisbane Botanic Gardens, with panoramic views from its summit.