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: +1-650-565-8542

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 Due to controversies and much discussion, this new guidance replaced the draft guidance from September 1998.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

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

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 customercare@complianceonline.com 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
    Loading