- GAMP & CSV (SYD-10-05-18)
9:00 am - 4:00 pm
Sydney 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”
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 2 9491 9950
Venue Website: https://www.edengardens.com.auAddress:
North Ryde Eden Gardens
The landmark North Ryde centre is a member of SUVA (Sydney Unique Venue Association).
Join PharmOut for training sessions in gorgeous garden surroundings that create a relaxing learning environment. Networking events and fully catered lunches are held in the unique outdoor garden settings, including several lawns and terraces and the garden theatre.
All function rooms are equipped with AV equipment and facilities.
The onsite undercover car park has over 200 car spaces and two coach bays.
The functions rooms are equipped with wireless broadband internet.
A variety of different accommodation options are available near to Eden Gardens.