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Pharma Secure Chain 2008
Lock Down Security against Counterfeit Medicines: Protect your Revenue and Reputation
October 20 - 22, 2008 · Thistle Marble Arch, London, UK

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Pre-Conference Master-Classes: 20th October 2008

09.00 – 12.00 Master-Class A: Creating a mass serialisation solution to meet all current legislation for track and trace and authentication

This master-class will consider:

  • Number allocation and management through the supply chain (from manufacture to the packaging process, via the distribution chain, right through to end-user)
  • How to ensure complete code tracking and traceability to meet legislative requirements
  • Essential system validation
  • High level software architecture and the functionality of server, line controller and user interface (server-client model)
  • The ability to print unique data matrix on blister pouch and blister strip
  • The option of hybrid RFID and printed bar codes at case and pallet level

Workshop leader:

Tony Walsh
Business Development, Control
Domino

12.15 – 15.15 Master-Class B: Protecting your Inbound Supply Chain by Auditing API Sources and Complying with new EU GMP Regulations

This master-class will consider:

With recent API sourcing scares, inability to track back where the products came from and the EU GMP requirements as detailed in Article 46 (f ) of Directive 001/83/EC and Article 50 (f ) of Directive 2001/82/EC; as amended by Directives 2004/27/EC and 2004/28/EC respectively, place new obligations on manufacturing authorisation holders to use only active substances that have been manufactured in accordance with Good Manufacturing Practice for starting materials. Pharmaceutical manufacturers are increasingly concerned on how to ensure the quality of their drug materials.During this workshop,Dr. Hosseiny will use his years of experience in auditing actual API manufacturers to give helpful advice on how to update your auditing process to remain compliant with European Legislation.

  • Understanding the early supply chain and how and where APIs are manufactured, sold and re-packaged
  • What to do when you simply don’t know the source of your API A – Z of auditing your inbound drug supplies
  • Understand the value of audit reports and what information the regulators expect them to contain
  • Explaining key pieces of the new EU GMP Part II that you must understand in order to comply
  • How to best manage your agents to ensure quality drug material

Workshop leader:

Afshin Hosseiny
Director
Tabriz Consulting

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