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Chemical Characterization of Medical Devices: Thoughts, Considerations & Points to Remember
September 24, 2020 @ 11:00 am - 12:00 pm
Recent regulatory guidance’s continue to emphasize the need for chemical characterization and extractable and leachable assessments as part of an overall device assessment. Additionally, there is also a need to utilize a risk-based strategy for planning and conducting testing for support of regulatory submissions.
In this hour-long presentation, Stephen Doherty Ph.D, Analytical Chemistry Director, will examine the different types of information available from a chemical characterization and how to get the information you are looking for from the testing. Dr. Doherty will also discuss:
- Strategies for study design and execution
- Common pitfalls and how to avoid them when developing a testing plan
- Latest regulatory changes around chemical characterization
- How to leverage analytical data for risk assessments