ComplianceOnline

Complaint Handling, MDR's & Recalls

Instructor: John Chapman
Product ID: 700830

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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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: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

Description

Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms.

Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters. FDA warning letters and recalls are posted on FDA’s website and published in trade magazines, newspapers available to firm’s competitors, and has even driven the firm’s stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

Areas Covered in the seminar:

  • FDA’s Complaint Definition 820.3 (b).
  • Complaint Documentation.
  • Part 803 – Medical Device Reporting.
  • Part 806 – Reports of Corrections & Removals.
  • Warning letters and other FDA Remedies.
  • Complaint Handling Pitfalls.

Who will benefit:
Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. This Webinar will explain the regulatory process and in understandable terms. Some employees who wish to gain a better understanding include:

  • Quality & Regulatory Professionals
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Corporate & Operations Executives

Instructor Profile:
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. RAB Accredited Lead Auditor Course Certificate1996. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.
John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented seminars on various regulatory subjects.

Follow us :
ComplianceOnline Medical Device Summit 2017
Radiation Sterilization of Medical Products

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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