ComplianceOnline

Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers

Instructor: Edwin L Bills
Product ID: 700957
  • Duration: 3 Hrs

Training CD / USB Drive

$499.00
$1,000.00 (50%)
Save $501.00
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: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This pack of 2 courses contains the essentials of FDA Medical Device regulations.

In the United States, the US Food and Drug Administrates Medical Devices through several different regulations, the principle one is the Quality System Regulation 21 CFR 820 (QSR). Other regulations include Registration and Listing, Labeling, Medical Device Reporting, and Corrections and Removals (Recalls). This 3-hour course pack will give an overview of all the major responsibilities for those who design, manufacture and distribute medical devices.

All Modules:

Module 1: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Part 1- Quality System Regulation
Module 2: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Part 2- Registration, Medical Device Reporting, Corrections and Removals (Recalls)

Module 1 : The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Part 1- Quality System Regulation
1 CD Price: $500
Instructor: Edwin L. Bills

Area Covered:

  • This session will identify who is responsible under the Quality System Regulation.
  • Identify the responsibilities of Suppliers to Medical Device Manufacturers.
  • Limits of the Design Control Regulation.
  • What is Validation? Includes Process, Design and Software Validation.
  • Preparing for Inspection.

Module 2 : The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Part 2- Registration, Medical Device Reporting, Corrections and Removals (Recalls)
1 CD Price: $500
Instructor: Edwin L. Bills

Area Covered:

  • This session will cover the responsibilities of the manufacturer for the regulations not covered in Part 1, Registration and Listing, Labeling, Medical Device Reports and Corrections and Removals (Recalls).
  • What are the additional responsibilities of the Medical Device Manufacturer?
  • What is Labeling-what about websites and videos?
  • Do I really have to report adverse events in multiple countries?
  • What field actions require reporting to the FDA?

Instructor Profile:

Edwin L. Bills , was a Quality and Regulatory Affairs Director at an international medical device manufacturer for 5 years after serving in a variety of positions with increasing responsibility in the medical device industry, including Supplier Quality Engineer and Manager, Quality Systems and Regulatory Affairs Manager, Product Risk Manager, and Director of North American Service Quality. He is Regulatory Affairs Certified by RAPS, and also a Certified Quality Engineer, Certified Quality Auditor, and Certified Manager of Quality/ Organizational Excellence by ASQ and is an ASQ Senior Member.

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

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