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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
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On-line Audio Seminar 318

FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

Recorded, available with all reference material at any time

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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. The industry is unsure how to interpret and implement the FDA 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 and checklist have been updated according to the 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
    - Out-of-Specification Data Trending
    - Laboratory Failure Investigations
    - Corrective and Preventive Actions
    - Investigating Manufacturing Incidents
  • Templates/Checklist:
    - Handling OOT Situations
  • 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/OOT and CAPA
  • FDA Guidance for Industry:
    Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production

Out-of-Trend Chart
s can clearly indicate the reason for the OOT result: e.g., Lab-error vs. manufacturing error. Attend the seminar to learn how.

Who should attend?

  • Laboratory managers and supervisors
  • GMP auditors
  • QA/QC 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

Recorded seminar, available at any time with all reference material

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.

Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explained FDA's next steps for Part 11

Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,