Managing Inspections without Stress: Coordinate Responses Flawlessly
Blog Post

Managing Inspections without Stress: Coordinate Responses Flawlessly

When it comes to being prepared for an inspection from a regulatory authority, the combination of preparation and practice will often make the difference between...

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FDA Approves Emergency IND in Less Than Three Hours
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FDA Approves Emergency IND in Less Than Three Hours

How a CAI agent helped make a difference (more…)

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Visit us at Table 9 at PDA EU Annual Meeting
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Visit us at Table 9 at PDA EU Annual Meeting

  (more…)

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E-Pub: The Importance of Annex 1
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E-Pub: The Importance of Annex 1

Annex 1 - "Manufacture of Sterile Medicinal Products." was first published in 1971. However, the first revision since then is currently in process. And this...

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Implementing USP Visual Inspection Requirements
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Implementing USP Visual Inspection Requirements

The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified.  (more…)

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