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

Instructor: Robert DiNitto
Product ID: 700117
Training Level: Advanced
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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

Instructor Profile:

Robert DiNitto, is a principal and one of the founders of AlvaMed, LLC, an innovative medical technology consulting firm. He leads AlvaMed’s QA/RA and Design Control practice, having over 35 years of experience in the medical device industry.

Bob has developed and implemented design control systems that have been well received by both engineering organizations and regulatory auditors, and received a high approval rating from an FDA auditor. His engineering experience, in roles ranging from project engineer to VP of R&D, covers many types of products from small, portable monitors with sterile disposables to large x-ray systems. He has designed electrical and mechanical hardware and software.

Bob has assisted numerous companies with development planning, including providing training and document templates for development, V&V, manufacturing, risk management, and regulatory plans as well as conducting hazard analyses and FMEAs, developing appropriate, easy-to-use risk rating scales and training personnel on risk analysis basics.

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