ComplianceOnline

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control

Instructor: Dr. Ludwig Huber
Product ID: 701666
Training Level: Advanced
  • Duration: 75 Min

recorded version

$399.00
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

$700.00
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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Read Frequently Asked Questions

In this training you will learn difference between Out-of-Specification (OOS) and Out-of-trend (OOT), requirements for OOT and how to manage OOT results for FDA compliance.

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. This seminar will demonstrate how to manage OOT results for FDA compliance.

Areas Covered in the Seminar:

  • Understand FDA regulations and guidelines.
  • FDA's final OOS Guidance for Industry: Requirements for OOT.
  • Difference between OOS and OOT result.
  • 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.
  • Examples: Going different types of case studies.

Hand-outs:

For easy implementation, attendees will receive
  • SOP: Handling OOT results
  • SOP: Out-of-Specification Data Trending
  • Checklist: Handling OOT Situations

Who Will Benifit:

  • Pharmaceutical industry
  • Contract Laboratories
  • Laboratory managers and supervisors
  • GMP auditors
  • QA/QC managers and personnel
  • Qualified persons (for EU compliance)
  • Analysts and other laboratory staff Regulatory affairs
  • Consultants

Instructor Profile:
Ludwig Huber Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com , the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .

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