GLOBAL REGULATORY REQUIREMENTS
Validation of Pharmaceutical Processes, Equipments/Apparatus, Basic concept in analytical method development for dosage forms, Computer System validation, ERP and SAP systems
Basics in drug approval process with ref. to: Orange Book, FOI, IIG, DMF, Historical aspects with various phases of drug development and approval, CMC
IND, NDA, ANDA, CONCEPT OF PARA I TO IV, EXCLUSIVITY:CONTENT, FORMAT & APPLICATION
U.S. Food and Drug Administration
Medical Control Council
COMMON TECHNICAL DOCUMENT (CTD) & EUROPEAN MEDICINESAGENCY (EMEA)
Medicines and Healthcare products Regulatory Agency
Therapeutic Goods Administration
ICH, WHO AND SUPAC GUIDELINES