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All documents shown here are included in the seminar for instant download

Investigating OOS Test Results. Presentation from FDA's Edwin Rivera, presented at the 31st International GMP conference, March 2007

The seminar includes 5 FDA Warning Letters related to the topic.


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 130

Managing Failure Investigations and OOS Situations

Regulatory Requirements and Strategies for Implementation


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No or inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters. Most companies have procedures but either they are not adequate or are not followed.

Key Questions related to Failure Investigations and OOS are:

  • What do FDA and other regulations say about Failure Investigations and OOS
  • What exactly are the expectations of inspectors
  • How to develop an efficient and compliant procedure for failure investigations?
  • When and what to retest?
  • How to manage batch investigations
  • How can I avoid OOS situations BEFORE they occur
  • How should I document failure investigations and OOS?
  • How to use risk assessment in determining the need for failure 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 strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA regulations and guidelines
  • Learnings from recent FDA 483's and warning letters
  • Developing an SOP for OOS situations
  • Responsibilities
  • Managing formal and informal laboratory investigations
  • Retesting: when and what to test
  • Managing batch investigations
  • Risk based failure investigations
  • Strategies to avoid OOS situations BEFORE they occur
    FDA compliant documentation of failures investigations and OOS

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

  • SOPs:
    - Handling OOS results
    - Laboratory Failure Investigations
    - Corrective and Preventive Actions
    - FDA Inspections - Preparation, conduct, follow-up
  • Templates/Checklist:
    - OOS Results
  • Reference Articles
    - Preventing Out-of-Specification (OOS) Situations Caused by Laboratory Errors
    - How to avoid warning letters
    - CAPA - A Fundamental Quality Subsystem
  • Five Warning letters and/or Inspectional observations related to OOS and CAPA
  • FDA Guidance for Industry:
    Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production

Who should attend?

  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • CAPA management
  • Documentation department
  • Consultants

How to order

Replaced by the more recent seminar

Handling OOS Test Results and Failure Investigations

With Case Studies on how to Avoid and Respond to Recent 483s/Warning Letters

Click here

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.