The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers - Quality System Regulation

Speaker

Instructor: Edwin L Bills
Product ID: 700921

Location
  • Duration: 90 Min
This program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.
RECORDED TRAINING
Last Recorded Date: Jun-2008

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$500.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

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Why Should You Attend:

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 program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices.

Areas Covered in the seminar:

  • 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.

Who will benefit:

This webinar is especially helpful for new startup companies that are entering the medical device field for the first time. It is also helpful for individuals that have not worked in the medical device field previously.

  • Personnel new to the field should take both Part 1 and Part 2 sessions.
  • Persons responsible for developing medical devices.
  • Persons responsible for manufacturing medical devices.
  • Persons responsible for purchasing components and services for medical device manufacturers.
  • Persons responsible for quality systems, quality assurance and quality control.
  • Persons responsible for servicing medical devices and for complaints.

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.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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