- GAMP (PER-07-03-19)
9:00 am - 4:00 pm
Perth 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: Novotel Langley - Perth
Venue Phone: +61 8 9221 1200
Venue Website: http://novotelperthlangley.com.au/Address:
Novotel Perth Langley
Novotel Perth Langley hotel is within walking distance of Perth’s vibrant shopping malls, restaurants, pubs, the beautiful Swan River and many other tourist attractions nearby, plus free city bus transport on your doorstep. Explore further afield to bustling Fremantle or Rottnest Island via train, bus or ferry.
Outside of the hotel, Perth and its beautiful parks and gardens are waiting to be explored.
The Novotel Perth Langley is less than 20 minutes from the Airport by car.
Wireless broadband is available in all conference rooms and public areas.
Undercover car parking is available on site.
Novotel Perth Langley hotel boasts 256 guest rooms and suites including Standard Rooms, 1 Bedroom Apartments, Perth Spa Suites and Deluxe Suites.
City: Perth, Western Australia
Perth, capital of Western Australia, sits where the Swan River meets the southwest coast. Its suburbs lie along sandy beaches, and the huge, riverside Kings Park and Botanic Garden on Mt. Eliza offer sweeping views of the city. The Perth Cultural Centre houses the state ballet and opera companies, and occupies its own central precinct, including a theater, art galleries and the Western Australian Museum.