David muchemu's bio
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cGMP PROFESSIONAL,SPEAKER,TRAINER,AND CONSULTANT FOR: 1.Quality system design 2.Process validation 3.CAPA 4.Change control INDUSTRIES:Pharma,Biomed,Med device
David muchemu's bio
- 1. An experienced Quality system professional knowledgeable in all facets of current Good Manufacturing Practices(CGMP) for biopharmaceutical drugs ,and Medical Devices, including assay development; preclinical product development and assessment; cGMP manufacturing of clinical materials, APIs, and final products; regulatory submissions; and quality system design and management. A proven leader for resolving CGMP problems and troubleshooting complex system problems related to product development, manufacturing, regulatory affairs, quality assurance, and quality control of biopharmaceuticals, Pharmaceuticals and Medical devices. EDUCATION University of New Mexico, Albuquerque, NM, BS., (ChE) Warren Wilson College, Swannanoa, NC, BA., (Biochemistry) Univ, Ithaca, New York B.S., (Biochemistry) HONORS Award of Merit, Knights of Columbus, 2010 National Institutes of Health Special Research Fellowship, National Institute of General Medical Sciences, 1971 to 1973. Best CAPA Instructor Peer Review, CGMP University Inc,2008 Consultant of the year, Peer Review, CGMP University Inc, 2011.
- 2. PROFESSIONAL ACTIVITIES Lecturer and author in the areas of Quality Control and Assurance of Biologics, Pharmaceuticals and Devices. Co-founder and CEO of CGMP University Inc. Instructor in Principles of Process Validation, Canadian Pharmaceutical Institute, Ontario, Canada. Instructor in Principles of Process validation, Center for Applied Training, London, UK. PROFESSIONAL SOCIETIES Regulatory Affairs Professionals Society IPA American Society for Quality PUBLICATIONS 1. How to write Standard Operating Procedures and work Instructions. David N.Muchemu, Creatspace, October 2010. 2. How to perform process Validation, David N.Muchemu, creatspace, May 2010 3. Principles of process validation. David N.Muchemu, Creatspace, January 2011. 4. Design Control for Medical Device, David N.Muchemu, Creatspace, May 2011 5. Change control for FDA regulated Industries, David N.Muchemu,Authorhouse,2007 6. How to design a CAPA system David N.Muchemu, Authorhouse, 2008. 7. How to design a Quality system David N.Muchemu,Authorhouse,2008 PAST CUSTOMERS
- 3. INDUSTRY CUSTOMER Medical Devices