This webinar will help you understand the critical ingredients for conducting an effective root cause analysis, also you will learn how to Analyze and document the root cause of the problem.
Why should you Attend:
The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop failure investigation / root cause analysis as an integral part of CAPA, Validation and Quality Management Systems / cGMP planning, implementation and execution.
Areas Covered in the Session:
Regulatory “Hot Buttons”
The 4 Basic Steps to Problem Solving
A Suggested Investigation Template
Monitor for Effectiveness
Lock In the Change – Close the Loop
Take It to the Next Level
Who Will Benefit:
Consultants,Others Tasked with Product
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
Event Fee: One Dial-in One Attendee Price: US$150.00
Compliance4All DBA NetZealous,