This Event has Passed
Tuesday, November 17, 2015
1:00 PM - 2:00 PM
1:00 PM - 2:00 PM See all dates and Times
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1547
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.
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:
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.
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.
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:
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.
