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.
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'.
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.
Course Provider
John E Lincoln,
