ComplianceOnline

Post-Marketing Strategies for Medical Devices - how to keep your device on the market

Instructor: Jeffrey Gibbs
Product ID: 700873

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
Last Recorded Date: Apr-2008

Training CD / USB Drive

$500.00
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

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This presentation will describe the principal regulation violations that trigger FDA enforcement action and the sanctions can invoke.

Description

This webinar will be of value to device companies that are marketing devices in the United States.

Device companies face many regulatory challenges with marketed devices. Devices are subject to a range of regulatory requirements, such as the Quality System Regulation and Medical Device Reports. The failure to comply can result in significant FDA sanctions, including warning letters, seizure, injunctions, prosecution, and civil penalties. This presentation will describe the principal regulation violations that trigger FDA enforcement action and the sanctions can invoke.

Areas Covered in the seminar:

  • What are the primary triggers for FDA enforcement.
  • The importance of effective compliance policies.
  • How do companies minimize the risk of FDA compliance actions.
  • What to do when regulatory violations occur.
  • How to respond to FDA if violations are found.

Who will benefit:

This webinar will be of value to device companies that are marketing devices in the United States. The employees who will benefit from this program are:

  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • In-House Counsel
  • Compliance Officers

Instructor Profile:
Jeffrey Gibbs, is a Director at Hyman, Phelps & McNamara, P.C., a law firm that focuses on FDA regulatory issues. Jeff previously worked at the FDA Office of Chief Counsel. He advises device companies on a wide range of issues, including post-marketing compliance. Jeff has written and lectured extensively on device issues.

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
Medical Device Summit 2018

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).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading