Auditing Failure or Process Deviation Investigations
Instructor:
Michelle Sceppa
Product ID: 701128
- Duration: 60 Min
Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause U.S. Food and Drug Administration (FDA) inspections.
Areas Covered in the seminar:
- Key elements of the audit process.
- How to correct audit observations for incomplete reports.
- Examine the steps necessary to ensure completion of various types of investigations.
- Various tracking systems to ensure proper follow-up.
- Ensure that SOPs and work instructions are updated to reflect any changes.
- Obtain timely approval of the investigation report.
- Anticipating and avoiding common barriers and obstacles.
Who will benefit:
This webinar will provide direction to perform audits of the Process Deviation and/or Failure Investigation System.- Managers
- Supervisors
- Associates
- 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.
More Training By Experts
- Deviations and Process Failures within a CAPA program
- Investigating Out of Specification Guidance (OOS) in the Laboratory
- 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
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