ComplianceOnline

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

Instructor: Dr. Ludwig Huber
Product ID: 702540
  • Duration: 75 Min

recorded version

$229.00
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

$399.00
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

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Fax: +1-650-963-2556

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Read Frequently Asked Questions

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.

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.

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

Areas Covered in this 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.

Who Will Benefit:

  • Analysts
  • Lab Supervisors and Managers
  • QA managers and personnel
  • Pharmaceutical R&D personnel
  • Documentation
  • Consultants
  • Contract laboratories
  • CROs

Instructor Profile:

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

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