We are a GMP consultancy that supports manufacturing, product design, regulatory compliance and Quality management in:
- The Pharmaceutical Industry
- The Bio-pharmaceutical industry
- The Medical Device Industry
- Water purification
- Beverage industry
Starting in January 2013, the U.S. Food and Drug Administration (FDA) expect generic drug manufacturers to implement Quality by Design (QbD) into their Abbreviated New Drug Applications (ANDA).
What you will learn:
1. CAPA life cycle: From discovery to CAPA closure.
2. QSR requirements for a CAPA system.
3. How to initiate Corrective Action and preventive Action.