Your event should be here ! To publish, manage, promote... To learn or to be formed ... Online registrations

Site language : English - Français
Ref : 30334
Event :Powerful Closed-loop CAPA - Meeting FDA Expectations

Date :Wednesday November 06th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.
 

Objectives

The most important area audited by the FDA is CAPA - it assures the FDA that companies are in compliance without the agency constantly auditing it.

Closed-loop CAPA mandates a repeatable, systematic failure investigation and root cause analysis - define, locate and resolve the basic problem(s) or root cause(s). A full-capture investigation, verification/validation, monitoring, change control methodology, coupled with accurate root cause analysis is crucial to a closed-loop CAPA system, that meets / exceeds CGMP requirements and U.S. FDA expectations.

This webinar will present simple but powerful tools, the systematic and regular use of which, can resolve the key underlying problem and close out CAPA documents in a timely manner. The information and tools presented in this webinar can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.

Program

  • U.S. FDA's CAPA Expectations
  • What is Closed-loop CAPA?
  • Correction, Corrective Action, Preventive Action
  • Failure Investigation Using an FI Template
  • 7 Powerful Tools for Root Cause Analysis
  • Investigation Detail - Root or Probable Cause
  • Impact - Often Neglected but of Major Importance
  • Effectiveness - Determining and Monitoring
  • Institutionalize vs. Entropy

Speakers


John E Lincoln
Principal, J E Lincoln and Associates
 

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

To access the information you need to be connected. Creating an account is easy and free!

Log to your account
Register on Doctorama

Details

Powerful Closed-loop CAPA - Meeting FDA Expectations Management
fda compliant capa, fda expectations for root cause analysis, failure investigation methodology, gmp audit, non-conformance, oos resolution, complaint handling, adverse event reporting and resolution
Professionals, This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology / defined systems, And simple but powerful tools for closed-loop CAPA, Including proper failure investigation / root cause analysis and making the fix permanent. This applies to companies in the medical device, Diagnostic, Pharmaceutical, And biologics fields. The employees who will benefit include: Senior management Regulatory affairs Quality assurance Production R&D and engineering All personnel tasked with problem solving
3 -- --
English

Other

For more information on Powerful Closed-loop CAPA - Meeting FDA Expectations, plsase contactr ComplianceOnline

To display announcer website, obtain a letter of invitation, you must be logged

Log to my account
Register on Doctorama


Recommend this event