How to do an Effective Hazard Analysis to meet FDA and ISO13485:2003 risk management requirements

This Hazard Analysis training will show you how to make the Hazard Analysis process work for you, what value it has for the entire life cycle of your product and how to use the process to help focus your design and process development efforts.

Are you performing a Hazard Analysis to meet FDA and ISO risk management requirements? Did you realize that if done correctly, a hazard analysis can actually save you time and money? This presentation will show you how to make the Hazard Analysis process work for you, what value it has for the entire life cycle of your product and how to use the process to help focus your design and process development efforts to target the most critical aspects of the product's intended use, helping you deliver a safer, higher quality product to your customers.

Areas Covered in the seminar:

• Why Hazard Analyses are required (and useful)
• How to use a Hazard Analysis to prioritize opportunities to increase safety
• Quantitative vs. Qualitative Approach
• Clarification of the terms Hazard, Hazardous Event and Hazardous Situation
• The common mistakes in determining occurrence and severity rankings
• What you can and cannot affect to reduce your risk to an ALARP (as low as reasonably possible) level
• Determining a risk threshold
• Revising and updating your Hazard Analyses

Who Will Benefit:

• Quality Assurance managers and personnel
• R&D managers & engineers
• Marketing personnel
• Regulatory Affairs personnel
• Quality system auditors