Deviations and Process Failures within a CAPA program

Instructor: Michelle Sceppa
Product ID: 701096
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Dec-2008

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements.


Many regulated companies still do not have a robust Failure Investigation and/or CAPA programs. Failure investigations and Corrective and Preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters. Companies have procedures but either they are not adequate or are not followed. This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements.

Areas Covered in the seminar:

  • Determining when a CAPA is necessary.
  • Integration of Root Cause Analysis.
  • Writing CAPA’s that are both appropriate and measurable.
  • Avoiding common pitfalls.
  • What is the Best Solution?
  • Recommending and Implementing Corrective Actions.
  • Tracking progress and re-evaluating corrective action effectiveness.
  • Documenting close-out and validating appropriateness of corrective action.
  • Challenges and solutions for improving the review and approval process.

Who will benefit:

This webinar will provide direction to all regulated companies that need to comply with CAPA requirements; including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields include:

  • Managers
  • Supervisors and Associates in the Pharamceutical and Device Industry that have daily responsibilities in Quality Assurance
  • Quality Control
  • Compliance and Manufacturing

Instructor Profile:

Michelle Sceppa, is the Principal at MSceppa Consulting, an establish Consulting firm and is in its 12thth year in the Industry that specializes in quality systems for Pharmaceutical and Biotechnology interests. MSceppa Consulting has implemented and managed Preclinical, Clinical, and Manufacturing Quality Assurance Programs for numerous clients. As the lead auditor, MSceppa Consulting has conducted and managed more than 400 internal and external vendor audits for Drug and Biologic firms in the US and Europe. MSceppa Consulting is knowledgeable in the details of compliance with all U.S. Federal Regulations-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) for Drugs, Biologics and Medical Devices.

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Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 call +1-888-717-2436 (Toll Free).

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