Post Market Surveillance in Today's Regulatory Environment

Instructor: Judy M Andrews
Product ID: 701398
Training Level: Intermediate
  • Duration: 60 Min

recorded version

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

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


Read Frequently Asked Questions

This Post Market Surveillance training/webinar will discuss how the Postmarket initiative of FDA impact your company and how to keep ahead of potential problems by knowing common , but avoidable mistakes and examination of some recent warning letters to know how the FDA views complaint handling, reporting and recalls.

Since announcing its Postmarket Initiative in late 2006 the FDA is taking active steps to monitor pharmaceutical and medical device product problems is the field. FDA is no longer waiting until an inspection to discover potential problems with marketed devices but has established partnerships for data gathering from public and government sources. This means that medical device companies must increase their vigilance in gathering, analyzing and addressing problems with their devices in distribution. The way you receive, investigate, analyze and act on information from users, patients and professionals can mean the difference between a safe and effective device and a costly product recall. Join this webinar to know :

  • What sources is the FDA currently using to identify product problems?
  • How will this new emphasis on postmarket surveillance impact your company?
  • A review of warning letters, 483 items and recalls with specific examples of FDA actions.
  • What sources should you be monitoring to keep ahead of potential problems?

Areas Covered in the seminar:

  • What is the FDA doing in postmarket serviellance.
  • Top 5 mistakes in postmarket surviellanceHow might my company be affected and what can we do.
  • How will the FDA Postmarket Transition Initiative affect how you receive and analyze complaints.
  • MDRs and Adverse Events - to report or not to report.
  • Four steps to better complaint follow-up.
  • Three sources new and emerging sources of customer feedback.
  • How to assess your recall risks.

Who will benefit:

This webinar would be valuable to all companies with products in the US market
  • Quality Systems Mangers
  • Sales Managers
  • Regulatory Managers
  • Quality System Auditors

Instructor Profile:
Judy M Andrews, Ph.D is Director of Quality and Compliance Services at Medical Device Consultants in North Attleboro Massachusetts. She has over twenty years of hands-on experience in the FDA regulation of medical devices. She has demonstrated expertise in developing, implementing, and auditing quality systems, together with a “value-added” approach, is a strong fit for medical device manufacturers seeking to comply with QSR, EN ISO 13485:2003, MDD, IVDD, or Canadian Medical Device She assists clients with recalls, U.S. and EU medical device reporting and FDA 483s and warning letters.

She holds a Ph.D. in Chemistry from Case Western Reserve University and an M.B.A. from Simmons Graduate School of Management. She is an American Society for Quality Certified Biomedical Auditor and Regulatory Affairs Certified. She serves on the board of the New England Chapter of the ASQ Biomedical Division.

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Product Reviews Write review

Nice presentation by Judith Andrews. Excellent reporting summary.
- Malcolm Card

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