Out-of-Specification Investigations, Identifying the Attributable cause or Laboratory Error

Instructor: John G Lanese
Product ID: 701411
Training Level: Basic to Intermediate
  • 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: Aug-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

This Out-of-Specification Investigations (OOS) training/webinar will guide you through initial laboratory investigation which follows the FDA guidance; Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.

Why should you attend :
It is important that the Quality Control Laboratory and the entire organization understand the impact of an Out-of-Specification result and what is required for an investigation that will survive the scrutiny of the regulatory investigators. This seminar will help the organization complete timely, compliant investigations that identify the root cause and appropriate corrective and preventive actions.

This seminar discusses what should be done when an analyst obtains a test result that is not within defined limits or one that is out of the historical trend for the test. The discussion begins with the initial laboratory investigation which follows the FDA guidance; Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. The seminar then considers what must be done if there is not an attributable laboratory error to include retesting and the involvement of the entire organization in the event that the original result is confirmed.

Areas Covered in the seminar:

  • Brief history on the emphasis of Out-of-specification results. - Why is the FDA interested, the Barr trial.
  • OOS investigations, an overview.
  • Laboratory Investigations - OOS Guidance - Phase I, Phase II.
  • Retesting - guidance, protocol, establishing that the original is an outlier.
  • Investigations beyond the laboratory - The deviation system, working with QA, production, facilities and materials management.
  • The investigation process.
  • Integrating with other quality system components - Investigations, CAPA, Change, Validation.

Who will benefit:

  • Laboratory supervisors
  • Analysts
  • QA personnel responsible for reviewing laboratory records
  • QA personnel responsible for investigations
  • QA management

Instructor Profile:
John G. (Jerry) Lanese, PH.D. CMC is the President of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small component manufacturer. He has lectured throughout the world to clients and for major seminar providers. He was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.

Follow us :
Latin America: Regulatory Compliance Requirements for Life Science Products
Upcoming In-person Seminars by EX-FDA OFFICIALS

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