ComplianceOnline

An Overview of Risk Management and Risk Analysis Techniques

Instructor: Robert DiNitto
Product ID: 700703
  • Duration: 60 Min

recorded version

$249.00
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

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Read Frequently Asked Questions

In this beginner seminar, we will review the concept of Risk Management, its various elements, what is required, and its benefits.

Description

The difference between risk analysis, risk evaluation, risk assessment, and risk management will be explained.

How are you meeting the FDA and ISO risk management requirements? Hazard Analysis? FMECA? dFMEA/pFMEA? Is it difficult? Is it even enough? Performing a risk analysis is often a dreaded and seemingly pointless chore for those involved, yet risk management is actually more than just risk analysis.

In this beginner seminar, we will review the concept of Risk Management, its various elements, what is required, and its benefits. The difference between risk analysis, risk evaluation, risk assessment, and risk management will be explained.

The various forms of risk analysis will be described, highlighting their key characteristics and objectives as well as their differences. The relationship between risk analysis methods and which ones should be used will also be covered. We will discuss examples of some of the most commonly used forms of risk analysis, explaining the techniques and terminology used, and will review who should perform them and when they should be performed. We will also discuss the evaluation and acceptability of overall residual risk.

We will also review the Risk Management Plan, the Risk Management Report, and the Risk Management File.

Areas Covered in the seminar:

  • Risk analysis, risk evaluation, risk assessment, and risk management.
  • The benefits of risk analysis and risk management.
  • Description of the different risk analysis methods.
  • Qualitative vs quantitative risk analysis.
  • Hazard Analysis.
  • FMEA & FMECA.
  • dFMEA & pFMEA.
  • Fault Tree Analysis.
  • Comparison of risk analysis methods: their relationships and differences.
  • Residual Risk.
  • Risk acceptability.
  • Risk management planning.

Who Will Benefit:

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

Instructor Profile:

Bob 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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