Live webinar Quality Risk Management By Steven Laurenz

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Description

Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions. In addition they will be able to identify key QRM terminology and recognize the four (4) key components of Quality Risk Management. Finally they will have a strong understanding of the key concepts associated with the risk management risk tools and their application.

Why should you attend :

Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and Controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization. There is much confusion on how to define risk and individuals often think of quality risk management as just a tool like FMEA analysis verses an overall QRM approach. This training will explain the important concepts associated with a QRM approach. 

Areas Covered

•   Recognize the purpose and value of Quality Risk Management (QRM), as well as how it applies to your job.
•   Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions.
•   Identify key QRM terminology.
•   Recognize the four (4) key components of Quality Risk Management
•   Identify examples of QRM tools and their application.

Who will Benefit

•   Senior quality managers
•   Quality professionals
•   Regulatory professionals
•   Compliance professionals
•   Production supervisors
•   Manufacturing engineers
•   Production engineers
•   Process owners
•   Quality engineers
•   Quality auditors
•   Development professionals
•   Senior development managers

Industries who can attend

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


Speaker Profile

Steven Laurenz

Steven Laurenz

Steven Laurenz– Chemical Engineering M.S. – Michigan State University

Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.

Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortiums.

Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics

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