ComplianceOnline

10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance

Instructor: John E Lincoln
Product ID: 700125
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

$249.00
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

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Risk Analysis training will be helped to see how to develop a compliant Hazard Analysis/Risk Management File and Report, as outlined in ISO 14971:2001, a standard recognized by the FDA and rapidly being adopted by industry.

Hence 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 14971:2001, 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:

  • Elements of ISO 14971: Narrative, hazard analysis and the Appendices, risk analysis tools and rankings, the Risk Management File and Report;
  • Locating and using sources of hazards / risks;
  • Parallel approaches to developing the document;
  • When to involve teams;
  • Who to consider for sign-offs / approvals;
  • How to use the completed document;
  • Ways to ensure it remains a "living (and useful) document".

Who Will Benefit:

  • Senior management, project leaders
  • Regulatory affairs
  • Quality systems personnel
  • R&D and engineering staff
  • All charged with new product development, regulatory submissions, initiating / overseeing product hazard analysis and remediation
  • CAPA and P&PC personnel desiring to reduce or redirect investigation and validation costs without sacrificing product safety and/or warranty costs.

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications / validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry.

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