CAPA Investigations - Tools for a Compliant and Effective Investigation Process

Speaker

Instructor: Carlos Rodriguez Garcia
Product ID: 704039

Location
  • Duration: 60 Min
This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.
RECORDED TRAINING
Last Recorded Date: Apr-2016

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$399.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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Why Should You Attend:

A central theme in every CAPA investigation is determination of reoccurrence. Reoccurrence of deviations, non-conformances, or incidents may be indicative of inadequate investigations and/or ineffective identification of CAPAs. Tracking and trending is the process by which reoccurrence is determined and adequacy of the CAPA system as a whole is demonstrated. This webinar has been specifically designed to delineate the essential elements of CAPA investigations.

Areas Covered in the Webinar:

  • International regulatory requirements for CAPA investigations
  • Insight into investigator or auditor expectations from CAPA investigations
  • Essential elements of CAPA investigations
  • Roles and responsibilities for CAPA investigations

Who Will Benefit:

This CAPA investigations webinar will provide professionals from pharmaceutical, biotechnology, medical device and active pharmaceutical ingredient industries with the necessary tools to investigate non-conformances and deviations. It will be of interest to personnel directly involved in completing, reviewing or approving investigations. Expected participation by:

  • Quality Engineers
  • Manufacturing Engineers
  • Quality Systems Managers
  • Operations Managers
  • Regulatory Compliance professionals
  • Consultants

Instructor Profile:

Carlos A. Rodriguez-Garcia, PhD, ASQ CSSGB, CBA is president of BioMed Pharma Consulting, LLC, an independent consulting firm providing services in quality management systems to the pharmaceutical and medical industries. Mr. Rodriguez-Garcia has over 15 years of experience in the regulated industry, the vast majority in quality management, encompassing a wide scope of products and processes: plastics, parenterals and aseptic processes. His experience includes conducting and approving CAPA investigations as well as training investigators in root cause analysis techniques and proper documentation of CAPA investigations to comply with FDA and EU requirements.

Topic Background:

CAPA investigations are a systematic documented process by which product quality is assured and risk to patient safety is mitigated. Investigations may arise from multiple sources, such as deviations from procedures, product non-conformances, component non-conformances, complaints, or incidents identified from the production process. The central element of a CAPA investigation is the root cause analysis. It is from the determination of root cause in a CAPA investigation that corrective and preventive actions are identified to assure product quality and improve process performance. Multiple investigation methods have been developed to identify root cause and establish effective corrective and preventive actions. The model introduced by Ishikawa (also known as fishbone diagram) is considered as one of the most robust methods for conducting root cause analysis. An adaptation, based on the assessment of the 6Ms (Man, Machine, Methods, Materials, Measurement, and Mother Nature- i.e., Environment), will be presented as a methodology for identifying true or most probable root cause to determine corrective and preventive actions.

CAPA investigations are comprised of multiple elements, of which the salient ones are:

  • Description of the Problem (Problem Statement)
  • Product Impact (Criticality and Corrections)
  • Root Cause Investigation
  • Corrective Actions and Preventive Actions
  • Effectiveness Plan
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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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