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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 227

Handling OOS Test Results and Failure Investigations

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


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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. Companies have procedures but either they are not in line with FDA's expectations or are not followed. Despite of the fact that the FDA has developed a guidance for investigating OOS results, the industry is unsure on what to do.

Key Questions related to OOS and failure investigations are:

  • What are the most critical OOS requirements?
  • What exactly are the expectations of inspectors?
  • Does the guidance apply to APIs and what are requirements of ICH Q7A?
  • Is there an equivalent guidance for Europe?
  • When should a full investigation be initiated?
  • Who has overall responsibility for evaluating investigation results?
  • How many times can/should we retest?
  • How to conduct a batch failure investigation?
  • When can we AVERAGE test results?
  • Who is responsible for OOS at contract laboratories?
  • Can we release a batch even if an OOS test is not invalidated?
  • How to deal with out-of-trend (OOT) results?
  • How to develop FDA compliant corrective and preventive action plans?
  • How can I avoid OOS situations BEFORE they occur?
  • What if the result meets compendial specs but not our internal specs?
  • How to 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 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.

During the interactive presentation you learn about:

  • FDA and international regulations and guidelines
  • FDA's Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
  • Learning from most recent OOS related FDA 483's and warning letters
  • Requirements of ICH Q7A for APIs
  • Developing an effective SOP for OOS situations and laboratory failure investigations
  • Managing formal and informal investigations in laboratories and manufacturing
  • Efficient use of checklists and forms
  • Compliant handling of retests
  • Retesting: what, when and and how many times
  • 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 root causes
  • Case Studies on How to Avoid and Respond to FDA 483's and Warning Letters

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

  • SOPs:
    - Handling OOS results (updated according to FDA's final OOS guidance)
    - Laboratory Failure Investigations
    - Corrective and Preventive Actions
    - Investigating Manufacturing Incidents
  • Templates/Checklist:
    - OOS Results (updated according to FDA's final OOS guidance)
  • Case Studies
    - How to Avoid 483s and Warning Letters Related to OOS and Failure Investigations

    - How to Respond to 483s and Warning Letters Related to OOS and Failure Investigations
  • Reference Articles
    - Preventing Out-of-Specification (OOS) Situations Caused by Laboratory Errors
    - 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 (October 2006)
  • FDA Presentation: Investigating OOS Test Results for Pharmaceutical Products
  • DOE: Root Cause Analysis Guidance (69 pages)

Who should attend?

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

Date, time and duration

Order at any time, replay at any time.

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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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.