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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...

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Top 2 FDA Citations to Avoid

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...

Innovations in Validation: Advancing Cell and Gene Therapies

Innovations in Validation: Advancing Cell and Gene Therapies

With the ever-changing mechanics of innovation in the manufacturing environment, work from home and federal regulation validation strategies need to evolve to accommodate the new space. This white paper provides the background, rationale, and strategy for innovating...

Inspections and Audits: What You Need to Know

Inspections and Audits: What You Need to Know

Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and learn about inspection and audit best practices in our series of blogs on inspection management. The Importance of First Impressions on Inspection Day Did...