ComplianceOnline

Biocompatibility Testing; what you need to know

Instructor: Mike Colvin
Product ID: 705585
  • 25
  • January 2018
    Thursday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 90 Min

Live Online Training
January 25, Thursday 10:00 AM PST | 01:00 PM EST | Duration: 90 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$449.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Webinar is geared toward those who require a working knowledge of biocompatibility.

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.

The objective of the Webinar is to teach participants how to use ISO 10993-1 and FDA standards to establish a biological safety evaluation plan, including how to document and implement their plan. Participants will not only learn how to assess their device for biological risks but also understand when testing is not necessary.

Areas Covered in the Webinar:

  • Risk-based approach to Biocompatibility evaluation strategy
  • Overview of ISO 10993-1
  • Biocompatibility testing guidelines, costs, and turnaround times
  • Leachables and extractables (L&E) testing as an alternative to costly
  • Time-consuming long-term animal testing

Who Will Benefit:

  • Regulatory affairs professionals
  • Compliance Managers
  • Quality Managers
  • Manufacturing Engineers
  • Research and Development
Instructor Profile:
Mike Colvin

Mike Colvin
Consultant, Syntilla Medical LLC

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.

Follow us :
Seminars by Ex-FDA Officials
Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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