Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

What is a Fishbone Diagram?

What is a Fishbone Diagram?

A Fishbone diagram is a risk management tool used to visualize cause and effect to analyze the root cause of a ...
When To Write A CAPA

When To Write A CAPA

A Corrective and Preventative Action (CAPA) is a tool utilized in order to address an issue or a potential issue ...
Decorative Contact Lenses

Decorative Contact Lenses

Decorative contact lenses are a known medical device and are treated with the same standards as corrective contact ...
Water for Pharmaceutical Use

Water for Pharmaceutical Use

When determining which type of water system is needed for pharmaceutical manufacturing it is important to keep in ...
How to Submit a 510K

How to Submit a 510K

Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, ...

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