SUCCESSFUL
IMPLEMENTATION OF
MANUFACTURING SITE
TRANSFERS

Conference Date: 13 Oct 2009-22 Nov 2009
Conference Ref: M10-6209
Fee: £1260 + VAT
Venue: Harrington Hall Hotel, London

This seminar will provide you with an overview of the regulatory, quality, logistics and project management consideration required for the efficient and effective transfer of both API and Drug Products between manufacturing sites, as well as the co-ordination of these activities with name changes, packaging and formulation rationalisation.

The seminar is intended to provide an overview of the practical problems and pitfalls associated with global manufacturing site transfers.  Case Studies will focus on major manufacturing rationalisation projects recently undertaken by industry.

Topics to be covered:

• Business ‘Drivers’ for Manufacturing Rationalisation
• Project Management of Global Cross Functional Teams and Activities
• Quality/GMP Compliance considerations during Manufacturing Rationalisation
• Compliance Risks
• Relevance and Opportunities of ICH Q8, Q9 and Q10
• Multiple Authority Inspections as a Result of Product Transfer
• Regulatory Principles, Problems and Solutions
• Project Management of Regulatory Affairs Activities
• Case Studies from Recent Major Industry Projects
• Putting Learning into Practice – Interactive Discussion and Workshops

Speakers:

• Bill Griffiths VP Global Regulatory Operations, Solvay Pharmaceuticals, Germany
• Malcolm Holmes Pharmaceutical Quality/GMP Consultant, Formerly Director of Quality, GlaxoSmithKline, UK

Click here to book your place on this important event.