Tutorials

Labcompliance tutorials should help to to get a good understanding on specific topics that are important for compliance with FDA and equivalent international regulations and guidelines. Typically they include

• A primer with basic information and recommendations for implementation
• Expert advice on selected topics
• Examples for warning letters, 483's and/or establishment inspection reports
• Literature references
• Links to other websites

Initially tutorials are accessible to all visitors of labcompliance at no charge. However over time they are moved to the Usersclub section and hence accessible to Club Members. Revenues from club membership fees will help to fund the development and maintenance of additional tutorials.  

Primer

The primer is the main part of the tutorial and should give good understanding of specific topics that are important to comply with FDA and equivalent international regulations and guidelines. Typically it includes an introduction to the topic, followed sections on regulatory requirements, approaches and detailed steps for compliance and recommendations and tools for implementation.

Examples for warning letters letters

Each tutorial includes a selection of at least five excerpts of FDA warning letters, 483 form inspectional observations and/or establishment inspectional reports. They should help to learn what inspectors are looking, what mistakes other companies make and how deviations are brought into compliance. Copies of full warning letters and inspectional reports can be downloaded from the usersclub section.

Expert advice on selected issues

These are relatively short articles on hot issues that come up over time. Expert advice will help readers to get a better understanding of some frequently discussed details. They start with a short description of the issue, followed by questions raised related to the issue and advice from Labcompliance.

Literature References

Each tutorial includes a literature reference list. Such references will help to get more detailed information and to back up decisions if necessary.

Links to other websites

Many times regulations and guidelines are published on the Internet. Sometimes regulatory information related to specific topics is not easy to find. The section has direct links related to the tutorial not only to official regulations and guidelines but also to websites published by private organizations and authors.