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We have several forms that help to implement the procedure consistently and effectively.

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them


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 288

FDA Compliant Sampling and Sample Handling in Laboratories

Strategies to Avoid Sampling Errors and Ensure Sample Integrity

Recorded, available with all reference material at any time

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Sampling is an important operation within the entire analytical testing process in which only a small fraction of a product is taken. Even though laboratory staff is usually not directly involved in sample acquisition they should pay attention about FDA compliant sampling. The best analysis can give misleading information if the test portion analyzed does not represent the sample or the lot from which it was taken. Valid conclusions on the whole test can only be based on representative sampling. Thorough handling of samples is important to ensure integrity of samples to prevent deterioration and cross contamination, to maintain sample tracking and the chain of custody, and to ensure safe disposal.  Correct sampling is thus an essential part of a quality system and for FDA compliance. However, there are no official guidelines which raises lots of questions about sampling and sample handling.

Key Questions related sampling and sample handling

  • What are the requirements of FDA and European agencies for sampling?
  • How to ensure and document representative sampling?
  • How to write a sampling plan?
  • How many samples should we take from a batch to be statistically safe?
  • How to define and justify Acceptance Quality Levels (AQL) for sampling
  • How much sample should we take?
  • How much reserve sample should we take?
  • For how long should samples be stored?
  • For how long should reserve samples be stored?
  • Who is responsible for sampling?
  • FDA requires a sampling plan, what exactly should be the content?

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 and international GLP/GMP requirements
  • Examples for Warning letters and how to avoid them
  • Requirements of ISO 17025
  • Sampling and sample handling as Part of the analytical process
  • Objectives of sampling and sample handling
  • Responsibilities for sampling
  • Sampling plan and SOPs for sampling and sample handling
  • Requirements for sampling equipment and tools
  • Requirements for sample containers and labeling
  • Sampling operating and precautions
  • Recommendations for sample handling and transport
  • Storing and retention of samples
  • Reserve samples: sampling, amount, requirements, storage
  •  Documentation for FDA and ISO 17025

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

  • SOPs
    - Sampling for Analytical Testing (531)
    - Handling of Laboratory Test Samples (534)
    - Reserve Samples in Laboratories
  • Checklist:
    - Sampling and Sample Handling
  • Forms
    - Sampling collection form
    - Sample receipt form
    - Sample transfer outside the laboratory
  • Five Warning letters and/or Inspectional observations related sampling and sample handling
  • WHO GMP Guidelines: Sampling of Pharmaceutical Products and Related Materials (24 pages)
  • EURACHEM Guide: Measurement uncertainty arising from sampling (2007)

Who should attend?

  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • Documentation department
  • 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.

Dr. 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 explined FDA'snext 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,