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

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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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.

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