2 GMP courses to ensure that your products get to market safely and never risk recall
SummaryThe EU GMPs were updated this year in February. As a result, Risk Management is a regulatory requirement and ICH Q9 is now Annex 20. EU regulators have also indicated that ICH Q10 on Pharmaceutical Quality Systems will become Annex 21 to the GMPs in June 2008 – sometime this month!
The EU GMPs were updated this year in February. As a result, Risk Management is a regulatory requirement and ICH Q9 is now Annex 20. EU regulators have also indicated that ICH Q10 on Pharmaceutical Quality Systems will become Annex 21 to the GMPs in June 2008 – sometime this month!
In line with these proposed revisions, Magenta Global is pleased to bring you 2 courses on critical issues in biopharmaceutical and medical devices manufacturing.
This is your timely chance to review the latest global initiatives and determine their impact on your operations. At the same time you will receive many insights and tips on how to develop and implement your VMP and PQS!
Do you wish to design a Validation Plan that performs value-add activities only?
You can learn how to do this at
A Risk Base Approach To
Validation Master Planning
21-22 July 2008 * Park Hotel Orchard * Singapore
Validation is one of the major compliance activities within a biopharmaceutical or API manufacturing company. This course will enable participants to understand regulatory expectations and will teach you how to integrate these expectations within your validation systems.
Is your Quality System Proactive or Reactive?
Find out first-hand at
Pharmaceutical Quality Systems
GMP & Risk Management
A Global Approach
23-24 July 2008, Park Hotel Orchard, Singapore
This course will help you to
• Implement modern quality systems & risk management programmes that
• Fully comply with the latest regulations and guidelines.
Your Course Director
Karen Ginsbury, an industry veteran, has helped numerous pharmaceutical companies successfully prepare for FDA, Health Canada and EMEA regulatory inspections. Currently she is also co-editing the ‘Technical Report on GMPs for Investigational Drugs’ commissioned by the Parenteral Drug Association (PDA)
For more information, please contact:-
Magenta Global Pte Ltd
Connecting Industry Professionals Worldwide
Tel: +65-6391 2533
Fax: + 65-6392 3592