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Primary (contact) materials, their composition and properties
Choosing the most appropriate material for specific applications
Pre-treatment of components
Requirements for receipt and testing
Supplier considerations
Pack Design
Contact packaging components
Reducing the risk of mix-up
Industrial codes of practice, e.g. PS 9000
The Packaging Process
Packaging machinery – an overview
Packaging operations – the GMP challenges
Recalls – an overview
In-process controls
Automatic security and detection systems
Regulatory Aspects
Stability testing requirements
Labelling regulations
Marketing Authorisation Application requirements for packaging components
The Route to the Patient
Wholesale dealing – including a visit to a wholesaler
Retail pharmacy visit
Concerns for the QP
Counterfeits
Controlled temperature storage and distribution
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice. Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific question and concerns.
Course Tutors
James Johnson, University of Strathclyde, Glasgow, UK
Mr Mike Halliday, NSF Pharma Biotech Executive Director
Stella Pearson Smith
External Course Coordinator and QP Administrator, Pharma Biotech
Georgian House 22-24 West End Kirkbymoorside York YO62 2AF
+44 (0)1751 432999
Contact us by email
