Stability Testing for Pharmaceutical Products
About this course
Over 50 companies failed their FDA inspection in 2003 because of deficiencies in their stability testing procedures. Without adequate test measures in place, you could well be on your way to adding to this statistic. PTI's practical 2-day course will provide an in-depth examination of EU and FDA guidelines and assess the latest tools and techniques for accuaret stability testing. Our experienced trainer will deliver real training solutions for you to transfer back to your work place.
What Will You Learn?
- Design compliant bracketing and matrixing strategies for stability data management
- Support IND/CTX and NDA/MAA submissions
- Meet ICH Guidance on photostability testing
- Analyse the latest ICH Guidance, Q1A (R2)
- Incorporate procedures for effective OOS investigations
Who Should Attend
This course is highly recommended for anyone working in pharmaceutical, medical device, biotechnology or biologics companies in the following departments:
- Analytical Chemistry/Methods
- Stability
- Microbiology
- Metrology
- QA/QC
- Manufacturing/Production
- Validation
- Regulatory Affairs
- GLP/GMP Compliance
- Chemical Engineering
- Research and Development/Chemistry
Reviews
"A very useful course in a relaxed atmophere"
"Well presented & informative"
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Dates and Venues
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Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
