Operations and Regulatory Consulting, Quality, Compliance, Regulatory

Managing Inspections without Stress: Coordinate Responses Flawlessly

November 22, 2021 || Connie Leech
 
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 success and failure. Regulatory Inspections are becoming increasingly complicated, comprehensive, and higher expectations are required based on the restrictions caused by the COVID 19 pandemic.…
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E-Pub: The Importance of Annex 1

May 21, 2018 ||
 
Annex 1 – “Manufacture of Sterile Medicinal Products.” was first published in 1971. However, the first revision since then is currently in process. And this revision will have impact way beyond the EU borders. World Health Organisation (WHO-all United Nations are members) and Pharmaceutical Inspection Co-operation Scheme (PICs) are actively…
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“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”

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