Stability Testing Of Pharmaceuticals
by Raymond MundenLanguages: English
Price (from): €1,488 / day
About the trainer:
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.
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Stability Testing Of Pharmaceuticals by Raymond Munden
About the training
#stability testing #pharmaceuticals
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.
Learning outcomes
Multiple Solutions
Understand the rationale for stability testing; Understand how to assess data and how to set shelf lives; Understand the effect of packaging on stability
Improve the chance of regulatory approval
Learn which guidelines are available and how to use them to their benefit and improve the chance of regulatory approval
Correct stability testing
Understand the correct stability testing to be carried out following changes to products
Design stability protocol
Learn how to design stability protocols in the most efficient manner enabling significant costs savings
Program
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
Packaging considerations
Sundry considerations
Matrixing and Bracketing Stability Studies
Main benefits
- #Wide collection of the biggest experts
- #Filters for all kinds of needs
- #User friendly platform
- #Fast and cheap
- #Highest level of proficiency
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