Deviations and Process Failures within a CAPA program
Instructor:
Michelle Sceppa
Product ID: 701096
- Duration: 60 Min
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
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.
More Training By Experts
- Investigating Out of Specification Guidance (OOS) in the Laboratory
- Auditing Failure or Process Deviation Investigations
- cGMP 'Pitfalls' in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection
- Maintenance and Calibration of Equipment
- Qualification and Audit of Suppliers and Vendors - A Risk Based Approach
Refund Policy
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