RACI PHARMACEUTICAL SCIENCE GROUP (NSW) _
Product Quality Reviews
Wednesday 21st July, 2010
North Ryde RSL Club
Cnr Magdala & Pittwater Rds, North Ryde, NSW
The new Code of GMP is effective the 1st of JULY 2010.
Does your company know and understand, the new requirements for Product Quality Reviews and the TGA expectations as of 1st JULY 2010?
This seminar will discuss the new requirements and the tactics of setting up and maintaining an effective and compliant PQR program.
12.30 - 1.00 Registration
1.00 – 1.15 Chairman’s Introduction
Will Glover
1.15 – 1.45 Regulatory and GMP requirements of PQR
Bruce Graham
1.45 - 2.30 Case Study - Complementary Medicines
Darren Dziedziczak, Quality Systems Manager, Blackmores
2.30 – 3.00 Case Study – Prescription and OTC Medicines
Graham Burgess, Compliance Manager, iNova Pharmaceuticals
3.15 - 3.30 Afternoon Tea
3.30 – 4.00 PQRs and Contract manufacturing.
Peter Haegens, Quality Assurance Manager, Australian Blister Sealing
4.00 – 4.30 Preparing a PQR procedure
Steve Williams, Director, SeerPharma
4.30 - 5.15 Practical yet effective PQRs – too little or too much?
Dr Mark Koen, Quality Assurance Manager, AstraZeneca
5.15 Questions
5.45 Drinks and Dinner
Product Quality Reviews
RACI Pharmaceutical Science Group – NSW
Wednesday 21st July 2010
North Ryde RSL Club
Enquiries for Payment/Registrations contact Edwina Hine: 02 9663 4960
Fax: 02 9385 6141 or
For further information regarding the seminar, please contact
Niesha Davis , Colleen Wood or
David Edmonds ,
GST Inclusive RACI Members $110.00
GST Inclusive Non RACI Members $145.00 Cost includes both Seminar and Dinner
Payment Options – Cheques are preferred, registrations close 12th July 2010.
TAX Invoice/Receipt ABN: 69 030 287 244
Date of issue: 12 July 2010
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Please forward your cheque in Australian Dollars payable to RACI, along with this completed form to RACI (NSW), School of Chemistry UNSW Sydney 2052.