Certificate in Device Shelf Life Testing
-- ViewingNowThe Certificate in Device Shelf Life Testing is a comprehensive course designed to equip learners with the essential skills needed to excel in the field of product testing and evaluation. This program focuses on teaching the latest methodologies and industry standards in shelf life testing, ensuring that participants are well-versed in the critical factors affecting product longevity and reliability.
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⢠Fundamentals of Device Shelf Life Testing: An introduction to the basics of shelf life testing, including definitions, purposes, and benefits.
⢠Regulatory Guidelines for Device Shelf Life Testing: A review of the regulatory frameworks governing shelf life testing, with a focus on FDA and ISO guidelines.
⢠Designing Shelf Life Studies: Best practices for designing and implementing shelf life studies, including study objectives, sample size determination, and test selection.
⢠Data Analysis in Shelf Life Testing: Techniques for analyzing shelf life data, including statistical methods and data interpretation.
⢠Stability Testing Methods: An overview of stability testing methods, including accelerated aging, real-time aging, and stress testing.
⢠Challenge Testing for Device Shelf Life: An exploration of challenge testing, including the selection of microorganisms, test conditions, and data interpretation.
⢠Shelf Life Extension Strategies: Strategies for extending the shelf life of medical devices, including packaging modifications, storage conditions, and revalidation.
⢠Case Studies in Device Shelf Life Testing: Real-world examples of shelf life testing for medical devices, including successes and failures.
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