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Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 169

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control

Comply with the most recent FDA guidance


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FDA's new 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". The industry is unsure how to interpret and implement the new guidance.

Key Questions related to OOT and related failure investigations are:

  • What is an OOT results?
  • What is the difference between OOS and OOT result?
  • What does it mean: The guide 'may' also be useful for OOT results?
  • 'How much' and 'what' of the guidance is useful for OOT results?
  • What exactly are the expectations of inspectors?
  • Can an OOT result trigger full investigations?
  • Who has overall responsibility for evaluating OOT results?
  • How to handle OOT results vs. OOS investigation?
  • Can we release a batch even if the OOT result can not be resolved?
  • How should we document OOT investigations?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present the requirements of the new FDA OOS guidance and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, worksheets, templates and examples will help immediate and cost effective implementation. The SOPs have been updated according to the new FDA OOS guidance.

During the interactive presentation you learn about:

  • 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
  • Examples: different types of case studies

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs:
    - Handling OOT results
    - Handling OOS results
    - Laboratory Failure Investigations
    - Corrective and Preventive Actions
    - Investigating Manufacturing Incidents
  • Templates/Checklist:
    - OOT Situations
  • Reference Articles
    - Preventing Out-of-Specification (OOS)
    Situations Caused by Laboratory Errors
    - CAPA: A fundamental quality subsystem
    - How to avoid warning letters
  • Five Warning letters and/or Inspectional observations related to OOS/OOT and CAPA
  • FDA Guidance for Industry:
    Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (October 2006)

Who should attend?

  • Laboratory managers and supervisors
  • GLP/GMP auditors
  • QA/QC managers and personnel
  • Responsible persons (for EU compliance)
  • Analysts and other laboratory staff
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Consultants

How to order

Replaced by the more recent seminar

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control

Comply with the FDA and international guidances

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About audio seminars


Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and 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, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.