One-Day Virtual Seminar

Biocompatibility Testing: What You Need to Know

BY: Mike Colvin Ph.D, Medical Device Technical Adviser/Consultant

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

Simu Live
(On-demand Streaming - Virtual Training Through WebEx)
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

The objective of the Seminar is to teach participants how to use the current 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. We will also cover how to properly document these findings and fill out a Biological evaluation report.

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 emphasize the use of risk-based approaches to assess Biocompatibility.

Who will Benefit:
  • Anyone with a desire to be up to date with the current state of the art of Biocompatibility assessment.
  • Medical device, pharmaceutical, and combination product start up and established companies.
Day 01(9:00 AM - 1:00 PM PDT)
  • Risk-based approach to Biocompatibility evaluation strategy ·
  • Overview of current ISO 10993-1 and collateral standards Biocompatibility testing guidelines, costs, and turnaround times.
  • Chemical characterization, leachables and extractables (L&E) testing, and toxicology assessments.
  • Alternative testing to costly and time-consuming long-term animal testing.
Mike Colvin
Mike Colvin Ph.D, Medical Device Technical Adviser/Consultant

Mike has over 30 years’ experience developing medical devices and systems. Over his career he has been in charge of safety & efficacy testing and Regulatory & Clinical strategies. He has also served as a technical advisor/consultant in the medical device industry for over 25 years, giving him exposure to both large medical device companies and startups.

Mike has taught college for over 25 years and has contributed/participated on many domestic and international technical committees. He holds a Ph.D. in Physical Chemistry from the University of Southern California/California Institute of Technology.

Register Now

Online using Credit card

$799.00

(One Dial-in One Attendee)

(After registration, we will video stream the training
on your convenient dates)

$4,999.00

Group-Max. 10 Attendees

(After registration, we will video stream the training
on your convenient dates)


For discounts on multiple registrations, contact customer care at +1-888-771-6965.

Other Registration Options

By order form / PO#

Payment Modes

By Check -

To pay by check please contact customercare@fdatrainingalert.com

By Wire -

Register / Pay by Wire TransferPlease contact us at +1-888-771-6965 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event »

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future FDATrainingAlert event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event FDATrainingAlert cancels the seminar, FDATrainingAlert is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending FDATrainingAlert conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by FDATrainingAlert for marketing, archiving or any other conference related activities. You agree to release FDATrainingAlert for any kind of claims arising out of copyright or privacy violations.

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