cGMP 'Pitfalls' in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection

Quality Control Laboratories continue to be a focal point of US FDA inspections and Compliance Audits. This program will focus on the principles and application of the FDA GMP regulations as they apply to the operation and management of today's pharmaceutical QC laboratory. The program defines the laboratory environment; points out problem areas and common pitfalls; and details solutions. The program also details how to prepare the Laboratory staff for an Inspection as well.

Areas Covered in the seminar:

• Regulatory requirements applicable to the QC Laboratory.
• Areas to Troubleshoot.
• Preparing for the Inspection-Facility & Staff.
• Hosting the Inspection.
• Inspection Do's & Don’t's.
• Concluding the Inspection.

Who will benefit:
This webinar will provide direction to all regulated companies that need to utilize the principles of GMP compliance for improved laboratory performance and overall compliance

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

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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