Embark on a comprehensive journey into pharmaceutical production with our course, “Active Pharmaceutical Ingredients & Excipients for Local Manufacturing.” Over four days, delve into topics like API synthesis, drug stability, regulatory frameworks, and GMP compliance. Explore the intricate world of API plants’ design, synthesis, and quality assurance. Uncover the vital role of excipients in drug development, understanding their manufacturing processes, quality control, and the nuances of patents and intellectual property. This course equips you with knowledge essential for achieving medicine and drug supply security in Africa, fostering sustainable API manufacturing practices, and ensuring compliance with international standards in pharmaceutical development.
COURSE INSTRUCTORS
Prof. Mojisol Christianah Adeyeye PhD, FAAPS, FAS, FNAPharm
Director-General, National Agency for Food & Drug Administration and Control (NAFDAC)
David R. Schoneker
President/Owner of Black Diamond Regulatory Consulting, LLC
Prof. Joseph Fortunak
Professor of Chemistry and Pharmaceutical Science at Howard University, USA,
co-developed a post graduate and Msc .in Regulatory Science.
Prof. Adeboye Adejare
Professor of Pharmaceutical Science at the Philadelphia college of Pharmacy
Dr. Christian Moreton Ph.D
Consultant and adviser of services in formulation and process design, development and
scale up in excipients for over 20 years and Partner, FinnBrit Consulting, Waltham, MA, USA
Dr. Patrick Lukulay
Founder and President of Technology Solutions for Global Health,
a consultancy firm based in Ghana
Hong Shen, Ph.D.
Senior Vice President and Head of China Innovation Center of Roche (CICoR)
Dr. Nkere K. Ebube, Ph.D., FPSN, FNAPharm, FNAPPSA
Senior Director, Technical and Analytical Operations at TerSera Therapeutics, Illinois, USA
Jared R. Auclair, Ph.D.
Vice Provost, Research Economic Development and Director of Bio-innovation
in the Office of the Provost at Northeastern University
Dr Trevor Laird
Managing Director: Trevor Laird Associates Ltd (UK)
Curriculum
- 4 Sections
- 32 Lessons
- Lifetime
- Day One9
- 1.11. Understanding Active Pharmaceutical Ingredients
- 1.12. What you need to know about API Manufacturing
- 1.13. Achieving Medicine Security in Africa
- 1.14. Achieving Drug Supply Security
- 1.15. Overview of Active Pharmaceutical Ingredients
- 1.16. Overview of API
- 1.17. Characterization of APIs and Excipients
- 1.18. Introduction to Stability Testing
- 1.1123
- Day TwoKindly click here to view day two pictures: https://wordvisionpictures.pixieset.com/nafdacworkshopday2/7
- 2.11. Regulatory Framework of APIs Manufacturing and Development
- 2.12. Introduction to GMP for APIs ICH Q7
- 2.13. Quality Risk Management ICH Q9_R2
- 2.14. Reference Standard for New Chemical Entities
- 2.15. Analytical Methods for Quantitative and Qualitative Determination of API
- 2.16. Design of API Plants
- 2.17. Design of API Plants Pt. 2
- Day ThreeKindly click here to view day three pictures: https://wordvisionpictures.pixieset.com/nafdacworkshopday3/7
- 3.11. Synthesis and Chemical Characterization of API
- 3.12. Physicochemical Properties of Drug
- 3.13. Design and Development of API Syntheses
- 3.14. Design and Development of API Synthesis_Impurities
- 3.15. Quality Assurance and Control of APIs
- 3.16. Drug Masterfiles
- 3.17. Green and Sustainable API Manufacturing
- Day Four9
- 4.11. Understanding Excipients and the Supply Chain
- 4.12. Excipient Manufacture
- 4.13. Effective Quality Control of Pharmaceutical Excipients
- 4.14. Manufacturing Process and Development Report
- 4.15. Qualification and Validation for Excipient Manufacturing Processes and Systems
- 4.16. Characterization of Pharmaceutical Excipients
- 4.17. Polymorphs Crystalization Bioequivalence
- 4.18. Change Controls in Excipient Manufacturing
- 4.19. Patents and Intellectual Property
