Webinar Getting R&D on Board with Risk Analysis

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , Certificate , Q/A and 60 Min Live Webinar

"Listen From Tom Kramer, president and CEO of Kablooe Design, has been a product innovator for over 26 years."

ISO 14971 & risk management


R&D activities are varied and many across the development process. When done correctly, these activities can be harnessed to provide valuable input to the risk analysis process, creating a seamless and robust risk analysis that is coherent with development and leads to stronger innovation.

You will understand how to conduct research activities and harness useful data from these activities to mitigate risk and create good design requirements. You will learn how to use this information to drive the development activities to be more efficient and result in a higher level of innovation. You will be able to create a group of colleagues and assign specific roles to execute these activities. You will also get worksheets and other tools to guide you as you undertake these research activities to support risk analysis.

Areas Covered

•        The role engineering plays in risk management 
•        ISO 14971 definitions of risk management items 
•        How to identify, estimate, evaluate and control risk 
•        Where risk activities fit into the development process 
•        How design development tasks lead to risk mitigation 
•        A short case study on risk mitigation

Who will Benefit

•        Program managers 
•        Project managers 
•        Engineering Directors 
•        VP of R&D 
•        Lead Engineer 
•        Senior Engineer 
•        Senior Designer

Industries who can attend

This 60-minute online course is intended for professionals in the Medical device, Design & Engineering Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Tom Kramer

Tom Kramer, president and CEO of Kablooe Design, has been a product innovator for over 26 years, and holds a Certificate in Master of Product Development from Northwestern University and a Bachelor’s in Industrial Design degree from MCAD. He also holds a certificate from Stanford University in Cardiovascular System in Health and Disease. He creates revenue for his customers by delivering innovative product solutions to their portfolios. Mr. KraMer spearheaded the D3 Process™ (Design Driven Development), a vehicle to provide these results to customers, and he teaches this process by traveling as a lecturer and speaking about innovation, creativity, and development processes.

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