Conference Description:

Overview:
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:
Engineering
Production
Operations
Consultants,Others Tasked with Product

Speaker Profile:
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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]