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