What are best practices for creating a Risk Management File?

Instructor: Dennis Moore
Product ID: 701233
  • 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
Last Recorded Date: Apr-2009

Training CD / USB Drive

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

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Read Frequently Asked Questions

This Quality management training will review processes for integrating a reasonable level of risk management into the quality management system.

Many companies are confident that their risk management process is compliant “enough” to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 cites are written and Warning Letters, seizures or worse ensue. Internal audits show the firm meets FDA risk analysis requirements, yet FDA writes the firm up. This presentation will review processes for integrating a reasonable level of risk management into the quality management system. Much emphasis will be placed during the talk on the risk management elements of the design control regulation, along with CAPA risk management concepts.

Areas Covered in the seminar:

  • What are best practices for creating a Risk Management File?
  • QSIT audit processes regarding risk management.
  • How do I counteract a possible FDA 483 cite?
  • What should be in my Risk Management File?
  • How do I correct the FDA compliance gaps in my risk management process?
  • How do I better audit my design control processes ?

Who will Students Learn:

  • How do I answer an FDA 483 cite?
  • Key mistakes in auditing practices.
  • What type of resource commitment is there to achieve risk management compliance?

Who will benefit:

This webinar will provide your firm with key insights on how to identify compliance gaps in your risk management processes. 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.

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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.

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