Some of the Learning Outcomes
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.
Background to Stability Testing and Guidelines
- The rationale for stability testing
- Relevant guidelines
Storage Tests, Conditions and Protocols
- Tests for drug substance and product types
- Storage conditions and periods required
- Typical protocols
- Developing global stability protocols
- In-use testing
Requirements for Existing Products, Line Extensions and Variations
- Guidelines available
- Requirements for active ingredient
- Requirements for product
- Requirements for variations to marketed products
Management of Stability Samples and Facilities
- Sample management
- Validation of storage facilities
- Ongoing validation
- How to treat excursions from condition
Developing Robust, Stability Indicating Methods
- Producing potential impurities of synthesis
- Producing potential impurities of degradation
- Guidance on stress testing
- Choosing columns and mobile phases
- Ensuring the method is robust
Light stability testing
- ICH Q1B Guidelines
- Light sources
- Required exposure
- Problems in light testing
Data Treatment, Shelf Life Assignment and Extrapolation
- When is statistical treatment required
- How much can extrapolation beyond real time data is allowable
- OOS/OOT results in stability
Packaging considerations
- Guidelines
- Requirements when changing packaging
- Demonstrating equivalence
- Interaction studies
Sundry considerations
- Bulk Stability
- Manufacture in zones III/IV to be sold in zone I
- Out of Specification in stability
Matrixing and Bracketing Stability Studies
- Bracketing designs
- Matrixing designs
- ICH Q1D guidelines
- What is acceptable for bracketing and matrixing
In addition there will be various exercises to reinforce the learnings.
Get to know 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 an 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 in stability 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.
Feel free to suggest the topics that you would like to learn about at
our Stability Testing Of Pharmaceuticals Course.
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Who should attend?
This course will be suitable for anybody involved in stability testing of new or existing drug substances and their products, including the design of stability protocols, analytical testing, sample and facilities management or writing or assessing the stability sections of product licence applications. Attendees could vary from those new to stability testing through to staff with several years of experience who wish to reinforce their knowledge and understanding of the best approaches to stability testing and to the management of stability samples and facilities.
- Analytical Scientists
- Quality Assurance Managers
- Stability Testing Scientists
- Stability Testing Managers
- Stability Facilities Managers
- Regulatory Affairs Scientists
