Events
ISPE AUDIT SUMMIT- TGA Audit Expectations and Common Audit Findings
The summit will commence with a presentation from Andrew Giles, TGA Auditor, followed by a Quality Leadership Discussion Panel facilitated by Bob Tribe, ex-Chief GMP Auditor and ISPE Asia Pacific Regulatory Affairs Advisor. The Leadership Panel will include experts in the fields of Medical Devices, Complementary, OTC and Prescription Medicines and Blood & Tissues Manufacturing from across Australia. The topic will be “Common Audit Findings”, an area that will no doubt generate some lively discussion and debate. The Audit Summit will be held at the Ranch Hotel, Epping, NSW on 22 July, 2008 commencing at 1.30 pm
Our Speaker Andrew Giles holds a Bachelor of Applied Science in Chemistry/Microbiology and prior to joining the TGA in September 2004, Andrew had 18 years experience in the pharmaceutical industry included 14 years experience with a sterile parenteral products manufacturer in the roles of Product Development Officer, Technical Operations Department Manager, and QA IT Compliance Manager.
Members of the Quality Leadership panel are:
Sarah K. Ballantyne, Compliance and Quality Manager, ARI ANSTO radiopharmaceuticals and industrials
Vincent Chung, Acting Quality Assurance Manager, CSL Bioplasma
Sharon Craggs, Senior Manager Quality Operations, Fort Dodge
Dr Sheryl Foster, QA Manager, Symbion Health, Consumer Product
Peter Kissane, Quality & Technical Director, LIPA Pharmaceuticals
John Linke, Associate Director Quality, Bristol Myers Squibb
Peter Louridas, Quality Operations Manager, Merck Sharp & Dohme
Gary Robinson, Vice president Quality Assurance, RESMED Asia Pacific
Debraj Sanyal, Quality Manager, inova
Sue Williams, Quality Assurance Manager, AstraZeneca
Brian Wood, Vice President Quality - APAC Region, Alphapharm Pty Ltd
Don't miss this opportunity to hear from the TGA and Australia's Quality Assurance leaders.
To download registration form, please click here
To register for the seminar, please send the attached registration form to:
Helen Green, ISPE Australasia Affiliate
Fax: +61 (03) 9370 3119
Email: helen.green@hotmail.com
ISPE Australasia Affiliate Audit Roadshow
In association with the ISPE Australasia Affiliate Audit Summit in Sydney on 22 July, the Affiliate would like to announce two satellite events in Adelaide (Wed., 30 July) and Melbourne(Thurs., 31 July).
Ex-Chief GMP Auditor and ISPE Asia Pacific Regulatory Affairs Advisor, Bob Tribe, will deliver a presentation on “Preparing for an Audit” and will then facilitate a forum on “Common Audit Findings” with a team of industry experts and ex-TGA representatives.
Venue and panel details will be available soon.
This will be an essential event for all industry members. The Affiliate hopes to extend the same format to Brisbane and New Zealand later in the year.
Sponsorship enquiries should be made to Andrew Watson on +61 0417-364-663 or andrewwatson@wilkore.com.au
Page last updated: 24 July 2008