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

Speaker

Instructor: Michelle Sceppa
Product ID: 701187

Location
  • Duration: 60 Min
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.
RECORDED TRAINING
Last Recorded Date: Feb-2009

 

$299.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$500.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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