PPT-Assessment of the legal, policy and operational environment of pharmaceutical manufacturing

Denis Kibira PhD National Coordinator MeTA Uganda CEO DUMAIC Global Health About MeTA amp DUMAIC MeTA is a multistakeholder platform to improve access to health commodities We are a catalystdriver for change. in Ethiopia. Prague,. . August 2016. . Ethiopia at a glance. 2. 3. Ethiopia is one of the largest countries in the world and it is fourteen fold of Czech. 4. Addis Ababa, Ethiopia: Africa’s Diplomatic Capital, and third biggest center of diplomatic hub in the world. & Quality Assurance :. GMP&QA. The GMP is enforced through Quality Management System (Q.M.S.) . The QMS starts with the concept of Quality Policy & Quality Manual. 1. 3.. QMS (Quality Management System). Neil . Corman. & Pat Sullivan. ISPE-. CaSa. Technology Conference. 31MAR16. Avid Solutions, a US-based systems integrator, and bioMérieux, . the leading global . medical diagnostics manufacturer. The Brookings Institution • . Washington, DC. Monday, October 19. th. , 2015. Promoting the Adoption of . Advanced . Manufacturing in the Pharmaceutical Industry: the FDA . Perspective. . Promoting Continuous Manufacturing in the Pharmaceutical Sector. Human Capital Outlook Implications for Skills Development in the Pharmaceutical Sector. Johannesburg. May 27 2015. Disclaimer . Any views or opinions expressed herein are solely those of the author and do not necessarily represent those of any company. March, 2018. “On-Demand Manufacturing . of Pharmaceuticals” . Technology Innovation Award. Finalist 2013. Perspectives and Learnings in Life Sciences Innovation: Opportunities for Growth. 2. 3/1/2018. the . dti’s. involvement in the State’s procurement of ARV’s . Directorate: Pharmaceuticals and Medical Devices. NATIONAL DEPARTMENT OF TRADE AND . INDUSTRY. 28 June 2017. 1. Overview of the South African Pharmaceuticals Industry . March, 2018. “On-Demand Manufacturing . of Pharmaceuticals” . Technology Innovation Award. Finalist 2013. Perspectives and Learnings in Life Sciences Innovation: Opportunities for Growth. 2. 3/1/2018. Sarah Verschaeve Sarah van den Brande. Counsel, Curia CVOA Counsel, Curia CVOA. 10 November 2017. UIA Round Table . Brussels. Topics. Changing legislative framework for (international) associations. the . dti’s. involvement in the State’s procurement of ARV’s . Directorate: Pharmaceuticals and Medical Devices. NATIONAL DEPARTMENT OF TRADE AND . INDUSTRY. 28 June 2017. 1. Overview of the South African Pharmaceuticals Industry . Pharmaceutical manufacturers are under continuous pressure to remain competitive while meeting the stringent regulatory manufacturing requirements. These manufacturing requirements range from simple electronic record keeping to complex data assuring consistently the reliability of the manufacturing processes, equipment and people’s training, raw material quality, sampling plans, root-cause-analysis, product’s deviations, etc. Atachi Systems’ experience in deploying MES for pharmaceutical manufacturing companies for several years in a row is a testimonial on its own. Put simply, Atachi Systems understands the importance of deploying an MES system that is strategic to its core manufacturing requirements, yet cost effective to maintain and run for years to come! Our clients call it the Atachi Advantage. Manufacturer of Pharmaceutical Pellets. Al . Wajer. . Pharmaceuticals LLC. is a professionally managed company, part of Pharmaceutical Group Company in Oman, involved in manufacturing and marketing of quality pharmaceuticals range of products (Pharmaceutical Pellets). The company has a state-of-the-art factory in Sohar Industrial Area in Oman. . September 8. , . 2017. Washington, D.C. . Customers.. #. MadeInUSA. Business.. Community.. $250B. Trends Driving Growth. of U.S. Manufacturing. U.S. INCREASINGLY COST COMPETITIVE. Leading energy input costs. & MRL Assessments. Executive Overview. What are MRLs?. Common language and standard for: . Assessing the manufacturing maturity of a technology or product and the plans for its future maturation.