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Top 2 FDA Citations to Avoid

The consequences of FDA citations can be costly. In this blog article, we discuss the top two FDA citations for pharmaceuticals and how to avoid or prevent them. In the United States of America, pharmaceutical drugs and medical devices are controlled according to The...

Reviewing Documents 101

When it comes to reviewing documents such as batch records, qualifications, validations, and other important documents, there are certain items that should be reviewed carefully. The reviewing of documents is a very important task within a company.  Let’s take a...

Quality 101 for Cannabis Products

Quality is the driving factor that keeps our food system safe. In the United States, there is an unspoken trust put into our food system to keep it safe. How does this safety happen? There are systems and procedures that maintain the integrity of the products consumed...

Wrapping Up the Inspection

This series on inspection success has stressed the importance of making a good first impression,  preparing your inspection management team, using inspection management software, who to have available during an inspection, and how to fulfill the inspector’s requests....

A Deviation has Occurred. What’s Next?

Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are...

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