ComplianceOnline

ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products

Instructor: John E Lincoln
Product ID: 700708
  • Duration: 60 Min

recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Dec-2007

Training CD

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An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version.

Description

Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry.

The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach This eliminates the current SOP-defined “one size fits all” approach, to a flexible, resource adjusted approach, less arbitrarily defined in an SOP, but yielding results targeted to real needs. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. Then how to use this document to accomplish the above goals.

Areas Covered in the seminar:

  • An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version.
  • The Hazard Analysis and its source material.
  • Use of the Appendices.
  • Concept of risk evaluation, control, reduction.
  • Risk management tools -- FTA, FMECA.
  • Residual risk.
  • Risk / benefit analysis.
  • The Risk Management Plan, File and Report.

Who Will Benefit:

This webinar will provide valuable information to all regulated companies that are developing, maintaining and updating their products' Risk Management Files / Reports. All regulatory activities have as risk-base approach, and compliance with risk management standards form the basis for using this approach. A risk based approach can best utilize limited resources for maximum impact in key activities such as CAPA, validation and verification, root cause / failure investigations, and similar. It offers an alternative to a "one size fits all" approach, most often used to ill effect in many companies.

  • For employees and management in the Medical Device, Pharmaceutical, Diagnostic, and Biologics industries
  • R&D
  • Engineering
  • Sales and Marketing
  • Consultants
  • QA/ RA/ QAE

Instructor Profile:

John E Lincoln, consultant, has successfully designed and implemented complete 21 CFR 210, 211, 820 and ISO 13485 quality management systems, which have passed FDA audits, and described in peer-reviewed technical articles and workshops, world wide. John has managed pilot production, regulatory affairs, product development, and quality audits. He has over 25 years of experience, primarily with medical devices – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine, the Journal of cGMP Compliance, Intermountain Biomed- ical Association, and publishes a newsletter. He is a graduate of UCLA.

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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.

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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