Applying Quality Risk Management (QRM) in Manufacturing – A Proactive Approach (RECORDED VERSION)



Applying Quality Risk Management (QRM) in Manufacturing – A Proactive Approach

Time: 1:00pm-2:30pm, EDT US
Duration: 90-Minutes
Price: $299 – Includes Bonus Handouts!

Course Description:

Quality Risk Management (QRM) has been a standard practice in many industries for a long time. However, the life sciences industry had been slow to adopt, and this continues with the latest trends and best practices in QRM.

This interactive session is intended to help you better understand and get familiar with best practices for the FDA approval process for quality risk management (QRM) as it applies to the pharmaceutical, biotech, and related life sciences industries. Content will further outline how risk management plans can be effectively integrated into an existing quality system. This webinar will help attendees understand risk management principles, risk management tools, methods, and processes applicable to a manufacturing environment. Finally you will learn how to develop and implement a systematic, holistic risk management strategy.

By attending this interactive, 90-minute webinar, you will be able to:

*Understand the basic tenets of risk management and how it applies to your environment

*Outline the requirements for applying risk management to the quality system
*Discuss how to conduct and implement risk management practices at your firm

*Review communication techniques to highlight the benefits of risk management

*Develop and all-encompassing risk management strategy that fits seamlessly with your quality ecosystem

General Course Outline:

-What is “Risk Management?”
-Regulatory requirements
-Key definitions
-Exploring the risk management process – systematic and integrated
-Reviewing RM principles
-Risk Management Implementation
-Using risk management tools and methods (PHA, HAZOP, HACCP, FTA, FMEA, FMECA)
-How to perform “risk ranking”
-How to facilitate Quality Risk Management
-Common mistakes and how to prevent common pitfalls
-Implementing risk control measures
-Risk Management Application and Integration
-Risk communication – How, When, & Why
-RM Applications for Operations, R&D, Materials, Facilities, Utilities, Equipment, Manufacturing, Labeling and Packaging, Laboratory Testing, and Quality Control
Relationship with other quality systems
-Implementing RM in an efficient and effective manner

Who Should Attend

This online training will benefit professionals in the following industries:

Medical Device
Human Tissue
Those who work in QA/QC, Regulatory Affairs, Manufacturing/Operations, Research and Development, and Legal roles will find this course highly beneficial.

Ad Reference ID: 95757d6fbb32fbfc

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