Scheduled On : Tuesday, November 12, 2013 at 10 AM PST | 1 PM EST
Duration : 90 Minutes
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And all personnel involved in verification and/or validation planning, execution and documentation.
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. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
Duration : 90 Minutes
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Description :
Vital elements of a robust, "bullet-proof", "closed-loop" Corrective and Preventive Action (CAPA) program include: "Gatekeeper" capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a "closed-loop" CAPA system will meet / exceed CGMP requirements and U.S. FDA expectations. Robust CAPA requires a specific sequence of activities, each building on the other, to enhance patient safety and improve product quality.
It is also key to many other important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, other Verification and Validation activities, Audit corrective and preventive actions, et al. Simple tools and work flow are not understood, diseminated, and used, consistently. Product failures, liability issues, scrap / waste / fall off, and needless recalls result, as evidenced in recent notorious events.
Avoid a "shoot from the hip" approach. Define, then attack, and resolve root problems / causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of the "closed-loop" CAPA system.
A robust CAPA requires repeatable, systematic Failure Investigation and Root Cause Analysis. The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for reslution of the key underlying problem -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s) -- using a repeatable system.
The most important area audited by the FDA is CAPA -- it assures the FDA that company is in compliance without the Agency constantly auditing it. One of the most cited 483 observation is failure to resolve the key underlying problem and close out CAPA documents in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s). Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.
It is also key to many other important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, other Verification and Validation activities, Audit corrective and preventive actions, et al. Simple tools and work flow are not understood, diseminated, and used, consistently. Product failures, liability issues, scrap / waste / fall off, and needless recalls result, as evidenced in recent notorious events.
Avoid a "shoot from the hip" approach. Define, then attack, and resolve root problems / causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of the "closed-loop" CAPA system.
A robust CAPA requires repeatable, systematic Failure Investigation and Root Cause Analysis. The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for reslution of the key underlying problem -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s) -- using a repeatable system.
The most important area audited by the FDA is CAPA -- it assures the FDA that company is in compliance without the Agency constantly auditing it. One of the most cited 483 observation is failure to resolve the key underlying problem and close out CAPA documents in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s). Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.
Areas Covered in the Session :
- Regulatory "Hot Buttons"
- CAPA Background
- Correction, Corrective Action, Preventive Action Defined
- Impact Analysis and Response - a Key Component
- CAPA System Assessment
- "Bullet-Proof"
- Data Sources / Metrics
- Monitor for Effectiveness
- "Closed-Loop" - Lock In the Change
- Beyond Regulatory Compliance
Who Will Benefit:
This 90 minute in-depth webinar will provide valuable assistance to all regulated companies that need to review and modify their company's CAPA system.
Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
- Senior management
- Middle management
- R&D
- Engineering
- Software
- QA / RA
- Manufacturing
- Operators
- Consultants
- cGMP instructors
And all personnel involved in verification and/or validation planning, execution and documentation.
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