Using Risk Analysis to Optimize Product Development and Manufacturing
Instructor:
Robert DiNitto
Product ID: 700166
Training Level: Intermediate
- Duration: 60 Min
Focusing on the wrong product development or manufacturing activities can not only waste your time and money but can affect the quality of your product and leave you unprepared for regulatory audits.
In this presentation, we will show you
- How to target your Design Input activities to focus on those areas that improve safety, minimize risk and improve quality
- How Design Output feeds back to Design Input using the Risk Analysis process
- How to target your Design V&V and Process Validation plans to the most critical aspects of your product and determine the minimum number of samples needed
- How to reduce or eliminate testing and inspections that do not bring value to your product or your business
An adequate testing, inspection and sampling plan will save you time and money while also helping you deliver safer, higher quality products to your customers.
This webinar - which assumes a basic understanding of the methodologies of and distinctions between Hazard Analyses, dFMEAs, and pFMEAs - will take you a step beyond performing Risk Analyses and documenting mitigations to the practical and proactive application of Risk Analysis results to achieve additional benefits.
Areas Covered in the seminar:
- How to use the HA to drive Design Input Requirements
- How to use the dFMEA as an additional link from Design Output back to Design Input
- How to use Risk Analysis as a tool in formulating your Design V&V strategy, including how to develop a risk based sampling plan
- How to use Risk Analysis as a tool in formulating your Process Validation strategy
- How to use the results of your Process Validation Strategy to drive your Inspection and Test Strategy
- How to safely reduce testing and inspections done in Production without compromising quality
Who Will Benefit:
- Quality Assurance managers and personnel
- R&D managers & engineers
- Regulatory Affairs personnel
- Quality system auditors
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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