PROGRAM 1 - QUALITY ASSURANCE AND rEGULATORY AFFAIRS

We are concerned with ensuring that the products comply with government regulations, while quality assurance professionals are focused on delivering high-quality products to consumers.

We are having 15 to 20 years work experienced faculty worked in top Indian Pharmaceutical companies

Featured Training Modules

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Quality Management System overview (QMS) & GMP

Elements of Quality Management System

Requirements for registration and approval of generic products for USFDA (ANDA), EU/AU/SA (Dossier), and TPD (ANDS)

Scale-up post approval changes (SUPAC) and variations

Qualification and Validation

 Vendor Management

In-process checks during Manufacturing

Case Studies

Program Details

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