ComplianceOnline

Investigating Out of Specification Guidance (OOS) in the Laboratory

Instructor: Michelle Sceppa
Product ID: 701127
  • Duration: 60 Min

recorded version

$249.00
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

Training CD

$450.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Pharmaceutical training provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits.

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 Due to controversies and much discussion, this new guidance replaced the draft guidance from September 1998.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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