Stability Testing in Pharmaceutical Development and Manufacturing (2 day)
21 Nov 2012 - 22 Nov 2012 - Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG
New and important techniques in stability testing are facilitating product development using the
Quality by Design approach. Using these it is possible to develop products more quickly and
reliably, through improved methods of shelf life prediction and excipient testing. New stability
testing protocols using the published ASAP method from Pfizer can generate information quickly and reliably. The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing in a highly interactive, relaxed environment:
• Why is stability testing required for product registration and GMP purposes?
• What are the requirements for Clinical Trials, new, and existing products?
• How can stability testing be applied during product development to shorten development times as well as improve product quality
• Stability testing outsourcing - successful management and execution
It will include:
• A comprehensive review of ICH stability testing guidance ICH Q1A
• Pitfalls in stability testing. Outsourcing—costs and benefits
• New approaches to stability testing including ASAP and the role of peroxides in product
• Stability Testing and QbD
• Workshops for attendees to present and discuss their own stability testing issues with the group
Who will benefit:
The course is designed for people working in:
• Analytical and Product Development
• Analytical Chemistry
• Stability Testing
• Formulation Development
• Regulatory Affairs
• Pharmaceutical & Biopharmaceutical Production
• Quality Control and Quality Assurance
• Technical Operations
The course will commence at 8.30 with registration and coffee, course proper will commence at 9.00 and finish at 5.00pm each day
• The life cycle approach to product development and Quality by Design
• Stability testing in product development
• ICH Q6 – specifications, and how to set them. Role of specifications in stability testing. Alternative approaches to deriving specifications
• ICH Guidance Q1A (R2) – a comprehensive review
• Case study
“Effect of Processing and Formulation Variables on the stability of a salt of a weakly basic drug candidate (tablet)” – Badawy et al, BMS
• EU GMP guidance on stability testing
• Evaluation of stability data – ICH guidance Q1E. Identifying out of trend data. Alternative approaches.
• Data interpretation case studies including attendee problems
• Bracketing and matrixing designs for stability testing of new drug substances and products - ISC Q1E
• Photostability testing—Q1B
• Action Planning and Final Q&A
Workshop and examples based on delegate’s interests
Group discussion, problem solving and consultancy
Online access to comprehensive publications including all relevant guidance will be provided as well as colour copies of all presentations and case studies .
Dr Michael Gamlen is Managing Director of Pharmaceutical Development Services Ltd,
a pharmaceutical consultancy based in Nottingham (UK). Dr Gamlen has over 30 years
experience of tablet development. Awarded a First Class Honours degree in Pharmacy,
specialising in Pharmaceutical Engineering, he studied for a PhD at Nottingham University.
He was Head of Tablet Development at the The Wellcome Foundation for 15 years, and
worked as an outsourcing manager before starting his consultancy business in 2000.
Dr Gamlen specialises in managing product development, formulation, tablet and process
development studies. He has been teaching professional tabletting courses for many years and
his courses are highly rated, exceeding the expectation of the participants in many cases.
Michael continually updates the content of his courses with the latest guidance and extracts of up-to-the minute scientific papers.
He provides a substantial body of relevant literature to all course participants as well as copies of all notes and guidance used and a workbook. He is a popular and highly respected presenter.