- Reasons for FDA violations….
- EU and US agree to share API and drug plant inspection data…!!!
- Regulatory Definitions for “Ambient”, “Room Temperature” and “Cold Chain”
- Quality by design approach: Regulatory Aspect………..!!!
- Bioavailability and Bioequivalance the Basic Approach…..
- BIOWAIVER….The Way Forward..
- DMF (Drug Master File)
- Drug Regulatory Agencies across the world
- Regulatory Affairs & its Role in Pharmaceutical
- Effective Dossier Management in Regulatory Affairs
May 24, 2017
- Annual Product Quality Review (APQR)
- Wet Granulation Techniques….!!!!
- Advanced Granulation Techniques….Prospective approach.!!!
- Granulation Particle Bonding Mechanism Process….An overview
- Data Integrity Guidance for Industry
- Corrective and Preventive Actions…Basic approach
- Installation Qualification For Sampling Booth
- Site Master File (SMF)