FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.

$999.00
Introducing
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Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Jul-2020

CD or USB Drive Only

(PPT + Recorded Training File)

$399.00
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
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Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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Why Should You Attend:

FDA's guidance on OOS test results requires failure investigations and other steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results. While most companies are familiar with and have procedures for OOS results, this is not the case for OOT situations. The guide states: "Although the subject of this document is OOS results, much of the guidance may be useful for examining results that are out of trend". Managing OOT results also helps to avoid time consuming OOS results. The industry is unsure how to interpret and implement the FDA guidance.

This session will equip you with the knowledge and comprehensive understanding of FDA requirements for Out-of-Trend Results in pharmaceutical quality control.

Areas Covered in the Webinar:
  • FDA regulations and guidelines.
  • FDA's final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
  • Difference between OOS and OOT results.
  • Developing SOPs for OOT situations and laboratory failures.
  • Investigating OOT results: what and how.
  • Retesting of OOT results.
  • Using historical data for OOT evaluation.
  • Using QC samples and product control charts for evaluation.
  • Developing corrective and preventive action plans.
  • Finding the root cause for OOT results.
  • Strategies to avoid OOS situations BEFORE they occur.
  • FDA compliant documentation of OOS, OOT, failure investigations, root causes and CAPA.
Free Hand-outs:

For easy implementation, attendees will receive

  • SOPs:
    • Handling OOT results
    • Handling OOS results
    • Out-of-Specification Data Trending
  • Checklist: Handling OOT Situations
Who Will Benefit:
  • Analysts
  • Lab Supervisors and Managers
  • QA managers and personnel
  • Pharmaceutical R&D personnel
  • Documentation
  • Consultants
  • Contract laboratories
  • CROs
Instructor Profile:
Kelly Thomas Kelly Thomas

Vice President, Americas Quality Operations at Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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. FDATrainingAlert 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@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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