courses
• Good Manufacturing Practice {Schedule-M}
• Good Laboratory Practice {Schedule-L-1}
• Documentation Management System
• Quality Program Preparation & Audit.
• Industrial Microbiology & Sterilization
• Clean Room Concept : HVAC
• Validation & Stabilities Studies. Client –Site Programmer
• In-house training
• Internal audit
• Human resource development
• Facility assessment for cGMP
Guidance –
• New Manufacturing set-up ,
• Existing premises: Extension, Modification.
• Documentation –
• Dossiers in CTD format & Drug Master File (DMF).
• Validation & stability studies, Vendor selection.
• Utility system: HVAC, Water system, compressed air. Certifications-
WHO-GMP,
National Agency of Food Drug Administration & Control NAFDAC-Nigeria. HSA-Health Science Authority-Canada. Mexico- FDA
US-FDA-United State-Food & Drug Administration. MHRA-Medicines & Healthcare products Regulatory Agency-UK. TGA-Therapeutic Goods Administration-Australia. EDQM-European Directorate for Quality of Medicines-Europe. MCC-Medicinal Control Council –South Africa. ANVISA-Brazil. CE-Pharma & Medical Device. NIHS-National Institute of Health Science-Japan (Ministry of Health & Family Welfare-Japan). Solutions-
• Manufacturing Problem,
• Personal Problem,
• Contamination Problem,
• Sterilization Problem
Educational Activity-
• Advance Diploma in Pharmaceutical Management (ADPM).
• Master of Pharmaceutical Management (MPM).
• Advance Diploma in Good Manufacturing Practice (ADGMP).
• Advance Diploma in Pharmaceutical Engineering (ADPE). Pharmaceutical Formulations- Manufacturing, Marketing in domestic & International Markets.
