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
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.
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.
More Training By Experts
- Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
- Change Control - Implementation and Management
- Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
- Medical Device QSR (21 CFR Part 820), Design Control, Hazard Analysis Under ISO 14971 and ICH Q9: Pack of 3 Courses
- Documenting a Risk-Based Quality System - for Compliance and Cost-Savings
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