Good Manufacturing Practice 3 Day Course

£1535 + VAT

12th - 14th November 2008

This stimulating and intensive course is aimed at pharmaceutical professionals who wish to increase their knowledge and understanding of GMP and examines why we have GMP, its legal status and the key GMP issues surrounding pharmaceutical manufacture.

The course builds on previous knowledge of delegates and is primarily aimed at key personnel working in QA, QC, production and engineering. It is designed so that the most important and fundamental issues associated with GMP are covered throughout the 3 days.

Course Content:

• Why do we have GMP?
• What is GMP?
• GMP in the USA
• THe USA code of Federal Regulations and FDA Inspection Guides
• Comparison between EU and USA GMP
• GMP issues in Production, Packaging and in the Warehouse
• Documentation
• People and training
• The history and legal status of GMP
• The UK Medicines Act (1968) and EU Directives
• The structure of the UK Orange Guide and EU Guide to GMP
• Production, QA, QC and hte QP
• Pharmaceutical Quality Management
• REgulatory bodies - including the MHRA, FDA, ICH and EMEA
• Manufacture of sterile, liquid and solid dosage forms
• Validation
• Site layout
• Water and HVAC systems
• Latest regulatory issues

To book a training course, please download the booking form, complete and email to bookings@rssl.com