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

Instructor: Michelle Sceppa
Product ID: 701187
  • 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: Feb-2009

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

The FDA Audit inspection training defines the laboratory environment; points out problem areas and common pitfalls; and details solutions and also details how to prepare the Laboratory staff for an Inspection as well.

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.

Follow us :
Seminars by Ex-FDA Officials
Latin America: Regulatory Compliance Requirements for Life Science Products

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).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed