An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version. 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.
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
Course Provider
John E Lincoln,
