Presenting Documents During Regulatory Inspections In Pharma

Pharma regulatory inspections by USFDA & other regulatory agencies are a common scenario in the pharma manufacturing units. The documents presented during these inspections are a very important assets & proper preparation is required for that specially the person who is going to present the documents to the audit inspector should be the best prepared. In this mini course learn what all should to be taken care of during these inspections. The various regulatory agencies which carry these regulatory audits / inspections are USA – Food and Drug Administration (FDA), UK – Medicines and Healthcare Products Regulatory Agency (MHRA), Australia – Therapeutic Goods Administration (TGA), India – Central Drug Standard Control Organization (CDSCO), Canada – Health Canada, Europe – European Medicines Agency (EMEA) etc.

What will you learn

• How to present the documents during pharma regulatory audits
• How to speak & what to speak
• How to be prepared with documents

Language: English

How to download course certificate: Watch Video