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

Training CD

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

Customer Care

Fax: +1-650-963-2556


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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