CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations - Webinar By GlobalCompliancePanel

Event Details

Time: May 8, 2013 from 10am to 11am
Location: Online Training
Street: 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
City/Town: Fremont
Website or Map: http://bit.ly/108uZ9v
Phone: 8004479407
Event Type: webinar, healthcare, medical, device, pharmaceutical, clinical
Organized By: GlobalCompliancePanel
Latest Activity: Apr 29, 2013

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Event Description

Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/or preventive actions (CAPA), and do proper impact analysis / actions. Such failure investigation and root cause analysis is a major element of cGMP compliance. If inadequately performed it is also a key source of regulatory problems.

Why you should 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. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT (devices) and ICH Q9 (drugs), underscore this increased emphasis. A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution.

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
Failure Investigation / Analysis Methodology - And One Possible Template
Use the 7 Tools to Find the Solution(s)
Monitor for Effectiveness
Lock In the Change - Close the Loop
Take It to the Next Level

Who Will Benefit:

Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants; others tasked with product, process, CAPA resolution, failure investigation responsibilities

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.

Price: $245.00

GlobalCompliancePanel

NetZealous LLC,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

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