Quality Assurance

Medical Device PMA

Medical Device PMA

In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory...

Types of Regulatory Audits

Types of Regulatory Audits

There are many different types of Regulatory audits that can be conducted. These are audits that upon successful...

Certificate of Analysis

Certificate of Analysis

A certificate of analysis (CoA) is a document that manufacturers create that verifies the products they manufacture...

When to Pursue Quality

When to Pursue Quality

Quality is something that should be integrated into an organization. To pursue quality means to drive forward...

Accelerated Stability Testing

Accelerated Stability Testing

Accelerated stability testing increases the rate of chemical degradation and physical change of a drug by using...

EU Technical Files

EU Technical Files

A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to the...

Product Testing of Cosmetics

Product Testing of Cosmetics

Cosmetics are a separate category under the Food and Drug Administration (FDA) different from medical devices or...

Pharmaceutical QMS

Pharmaceutical QMS

A quality management system, QMS,  is a crucial requirement for any organization in the life sciences industry....

Aseptic Technique

Aseptic Technique

Aseptic technique is the practice and procedures utilized to prevent contamination from pathogens. There are four main...

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