Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation

Speaker

Instructor: Dennis Moore
Product ID: 700192

Location
  • Duration: 60 Min
Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard. Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.
RECORDED TRAINING
Last Recorded Date: Nov-2007

 

$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

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

This presentaion will review the sections of the QS Reg.design control regulation which have requirements not present in the ISO 13485:2003 standard. Actual design control/FDA data will be discussed, which shows the agencies’ design control compliance directions. FDA investigator techniques will also be discussed.

Areas Covered in the Seminar:

  • What are the key differences between design control rules of the QS Reg. and the ISO 13485:2003 standard
  • QSIT design control audit process
  • How do I counteract a possible FDA 483 cite
  • Where does risk management fit in
  • How do I correct the FDA compliance gaps in my design control process
  • Should I create one quality system which complies to both rules
  • How do I better audit my design control system
  • How do I train my staff in design control compliance

What Attendees will Learn:

  • How do I answer an FDA 483 cite to FDA
  • How do I improve my design control Internal audit process
  • What type of resource commitment is there achieve dual compliance

Who Will Benefit:

This web seminar will provide your firm with key insights on how to identify compliance gaps in ISO 13485:2003 design control quality systems. The webinar will help you avoid FDA 483’s and warning letters The employees who will benefit include:

  • Regulatory Managers
  • QA Managers and employees
  • Government Auditors
  • Quality System Auditors
  • Industry Consultants
  • ISO 13485:2003 auditors

Instructor Profile:

Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts. Mr. Moore has performed hundreds of FDA device and drug inspections, and written many FDA 483 and warning letter citations. He also has industry experience on the manufacturer side of the auditing desk.

Follow us :

 

 

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).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method