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To Facilitate a Closed-Loop Problem Resolution System
Date
Jan 18, 2021 - 10:00 AM
Link to Website
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
161 Mission Falls Lane, Suite 216,,
Fremont,
California,
United States,
ZIP: 94539
Phone: 8004479407
Ticket Price: One Dial-in One Attendee Price: $150.00
Overview:
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations.
Why should you Attend:
Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are growing among regulatory agencies world-wide.
Areas Covered in the Session:
Regulatory "Hot Buttons"
The 4 Basic Steps to Problem Solving
A Suggested Investigation Template
ID / Document the Problem - CAPA, et al
Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations.
Why should you Attend:
Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are growing among regulatory agencies world-wide.
Areas Covered in the Session:
Regulatory "Hot Buttons"
The 4 Basic Steps to Problem Solving
A Suggested Investigation Template
ID / Document the Problem - CAPA, et al
Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Event Categories
Keywords: Educationa