Reliability Assessment for Medical Devices and Combination Products: Meeting FDA Objectives and Requirements – Webinar Recording/Transcript
Product Details
The FDA requires device developers to quantify probable reliability when assessing their products, particularly injection and delivery devices used in combination with drug products. But agency advice on the subject is limited to a single draft guidance for emergency-use pen injectors, leaving manufacturers of other types of devices to choose between multiple statistical approaches, each producing differing degrees of reliability probability.
In this presentation, you’ll gain an understanding of risk-based approaches to determining reliability of all medical devices and combination products.
Peter Knauer, a CMC and RA expert, walks through statistical approaches that have been previously used and accepted by the FDA to help your devices keep up with expanding FDA recommendations. He discusses the FDA’s 2020 draft guidance on developing fault tree analyses (FTA) for pen injectors, clarifying the link between reliability calculations and device approvals.
Presentation Takeaways:
- Understand device reliability
- Learn the current FDA thinking around reliability
- Discover risk-based approaches to determining reliability, such as FTA
- Undertake probabilistic determinations of reliability
- Demystify the math behind reliability calculations
Take some of the guesswork out of your reliability assessment and implement tried and true statistical approaches with this presentation.
Meet Your Presenter
Peter Knauer has more than 30 years of CMC leadership experience in the biomedical industry. Knauer has served as vice president of CMC/RA as well as QC/Analytical for U.S. and international companies, such as Xeris Pharmaceuticals, British Technology Group, Protherics, Jade Therapeutics, Symic Biomedical and BioUtah. He started his career at Genentech, where he held numerous leadership and technical positions in pharmaceutical development and drug delivery. He has directly overseen multiple NDA/BLA approvals and 510(k)/PMA clearances.
Who Will Benefit
- Design engineers
- Process engineers
- Manufacturing engineers
- Quality control staff
- Regulatory affairs staff
- CMC/RA staff