Biological Safety Evaluation Plan, Risk Assessment and Evaluation Report
Instructor:
Mike Colvin
Product ID: 705786
Training Level: Basic and Intermediate
- Duration: 90 Min
Why Should You Attend:
All medical devices that have direct or indirect contact with the human body require an assessment of the biocompatibility of the materials used to manufacture the device, with the test schedule depending on the nature and duration of body contact. Domestic and international regulatory bodies are encouraging the use of risk-based approaches to assess biocompatibility rather than strictly following the specified testing matrix. A biological test plan, assessment, and report are required.
Attend this webinar to acquire a working knowledge on how to properly prepare a biological evaluation plan and report and understand Risk-based approach to Biocompatibility evaluation, testing, safety assessment.
Areas Covered in the Webinar:
- Risk-based approach to Biocompatibility evaluation strategy.
- Overview of ISO 10993-1.
- Biocompatibility testing guidelines.
- Preparing a biological evaluation report.
- Leachables and Extractables (L&E) testing.
- Biocompatibility safety assessment.
- Preparing a biological evaluation report.
- What needs to be in the plan and report?
Who Will Benefit:
Anyone with a desire to be up to date with the current state of the art of Biocompatibility assessment.
- R&D
- Regulatory
- Compliance Staff
- Managers
- Quality Personnel
Mike Colvin
Medical Device Technical Adviser/Consultant
Dr. Mike Colvin has over 30 years direct experience in managing Biocompatibility assessment and testing, working in the medical device and combination products field. He has worked on/contributed to many domestic and international Biocompatibility committees, and has been a consultant to the medical device industry on the proper Biocompatibility strategies for success.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
