Investigating Out of Specification Guidance (OOS) in the Laboratory

Speaker

Instructor: Michelle Sceppa
Product ID: 701127

Location
  • Duration: 60 Min
This Pharmaceutical training provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits.
RECORDED TRAINING
Last Recorded Date: Jan-2009

 

$249.00
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)

$450.00
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

In October 2006, the FDA released the OOS final guidance document entitled Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. This document provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits. Due to controversies and much discussion, this new guidance replaced the draft guidance from September 1998.

Areas Covered in the seminar:

  • Requirements for investigating OOS results in the laboratory area.
  • Responsibilities of the analyst and supervisor.
  • Extension of the investigation to manufacturing processes and raw materials.
  • Discuss the interpretation of investigational results.
  • Quality Control Unit responsibilities when concluding the investigation process.

Who will benefit:

This webinar will provide direction to all regulated companies that need to comply with FDA’s OOS final guidance document entitled Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
  • 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.

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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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