Hazard Analysis & Risk Management - New 14971

Attendees will be helped to see how to develop a compliant Hazard Analysis/Risk Management File and Report. 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 the newly revised 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:

• Elements of ISO 14971: Narrative, hazard analysis and the Appendices, risk analysis tools and rankings, the Risk Management File and Report.
• Changes from the previous version.
• 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'?
• Attendees for this 90-minute webinar will also receive a suggested Risk Management File template.

Who Will Benefit:

• Senior Management.
• Project Leaders.
• Regulatory Affairs.
• 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.