Audio Seminars

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

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 123

Managing OOS Deviations and Corrective/Preventive Actions

Regulatory Requirements and Strategies for Implementation


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No or inadequate procedures for handling out of specification (OOS) situations, failure investigations and corrective and preventive actions (CAPA) 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 OOS and CAPA are:

  • What do FDA and other regulations say about OOS/CAPA
  • What exactly are the expectations of inspectors
  • How to develop an efficient and compliant procedures for failure investigations?
  • When and what to retest?
  • How to identify and document root causes
  • How to develop FDA compliant corrective&preventive action plans?
  • How can I avoid OOS situations BEFORE they occur
  • How should I document failure investigations and CAPA

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 on SOP for OOS situations

  • Managing formal and informal investigations

  • Retesting: when and what

  • Developing corrective and preventive action plans

  • Root cause analysis

  • Strategies to avoid OOS situations BEFORE they occur
    FDA compliant documentation of OOS, failures investigations and CAPA

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

  • SOPs:
    - Handling OOS results
    - Laboratory Failure Investigations
    - Corrective and Preventive Actions
  • Templates/Checklist:
    - OOS Results
  • 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 and CAPA
  • FDA Guidance for Industry:
  • Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
  • DOE: Root Cause Analysis Guidance (69 pages)

Who should attend?

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

How to order

Replaced by the more recent seminar

Managing OOS, Failure Investigations, and CAPA

Understanding and Implementing FDA Requirements

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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.