Price (from): €1,488 / day
Dr. Munden has more than 40 years experience in pharmaceutical research and development of which 33 years were with GlaxoSmithKline, his last position there being Head of Analytical Services Europe. He has extensive knowledge of all aspects of pharmaceutical development, with expertise in analytical method development and validation, analytical equipment qualification, degradation chemistry studies, chemometrics and in particular, is an acknowledged expert instability testing and management. He is now a Pharmaceutical Development Consultant and is a skilled trainer in various aspects of Pharmaceutical Development having run numerous training courses worldwide and has also lectured on Pharmaceutical Analysis MSc courses. He is a past Chairman and current committee member of the Joint Pharmaceutical Analysis Group in the UK.
About the training
A 2-day course on all aspects of stability testing that will enable attendees to fully understand the rationale for stability testing and how to carry it out in a highly efficient manner.
In addition, there will be various exercises to reinforce the learnings.
Understand the rationale for stability testing; Understand how to assess data and how to set shelf lives; Understand the effect of packaging on stability
Learn which guidelines are available and how to use them to their benefit and improve the chance of regulatory approval
Understand the correct stability testing to be carried out following changes to products
Learn how to design stability protocols in the most efficient manner enabling significant costs savings
Background to Stability Testing and Guidelines
Storage Tests, Conditions and Protocols
Requirements for Existing Products, Line Extensions and Variations
Management of Stability Samples and Facilities
Developing Robust, Stability Indicating Methods
Light stability testing
Data Treatment, Shelf Life Assignment and Extrapolation
Matrixing and Bracketing Stability Studies