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Biocompatibility: ISO 10993-2018- What’s Different?
September 3, 2020 @ 6:00 pm - 8:00 pm$10 – $25
Biocompatibility: ISO 10993 – 2018
2 Hours Towards Your RAC Recertification
SEP 3 2020
6:00 pm – 8:00 pm
Program Managers: Adam Lambert /Eri Hirumi, Program Chairperson for OCRA
- James Morrison, Senior Consultant, Brandwood CKC, ISO/TC 194 Member.
- Caitlin Bancroft, JD, RAC, Senior Regulatory Affairs Specialist, Pharmatech Associates, Inc.
Standards are constantly changing. ISO 10993 on Biocompatibility is one of them. Do you know what the latest 2018 version contains? What are the new requirements? How can you implement testing efficiently without undue cost but ensure smooth reviews by the FDA and EU Notified Bodies. How do you address requests for additional testing?
Come and hear how the FDA is handling this and what you can expect. Forewarned is being Forearmed.
Topics covered include:
Part 1: ISO 10993 Updates
- Key recent changes of ISO 10993 specifically:
- Part 7 (2019) EtOH sterilization
- Part 9 (2019) on Degradation products,
- Part 15 (2019) on degradation products from metals and alloys
- Part 18 (2020) on Chemical Characterization of a Medical Device within a Risk Management Process.
- Work in Progress changes for 2020
- How to leverage toxicological risk assessments to meet requirements
- The rising prominence of chemical characterization and the efforts to eliminate animal testing
Part 2: Practical Focus
- An overview FDA expectations and requirements
- How to leverage gap assessments for legacy and new products
- Case studies
- Best practices for study designs, analysis
- OCRA Members: $25
- Non-Members: $100, includes 1-year OCRA membership
- Government and Student Members: $10, with student/government ID
- Non-Member Government and Student Rate: $45, includes 1-year OCRA membership
James Morrison (https://brandwoodckc.com/ )
Senior Regulatory Consultant at Brandwood CKC with a background in Materials Science and Toxicology. He serves as involved in Toxicological Risk Assessment and Biocompatibility Consulting. James is the head of the Australian Delegation to ISO/TC 194 (ISO 10993). He has particular expertise in respiratory devices and was very active in the development of the ISO 18562 series. He is also heavily involved in the following working groups: WG 1Systemic approach to biological evaluation and terminology, WG 5 Cytotoxicity (Convenor), WG 6 Mutagenicity, Carcinogenicity & Reproductive Toxicity, WG 11 Allowable Limits for Leachable Substances, WG 14 Material Characterization, WG 15 Strategic Approach to Biological Assessment and WG 17 Nanomaterials.
Caitlin Bancroft (https://pharmatechassociates.com/ )
Senior Regulatory Affairs Specialist at Pharmatech Associates with expertise in all phases of medical device and combination product lifecycle management. She received her Juris Doctor from George Washington University Law School where she specialized in food and drug, healthcare, and administrative law. Her experience includes medical device regulatory submissions, product development using design controls, risk management, quality systems, and clinical affairs.
OCRA Registration Instructions:
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