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.

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

INDUSTRY CUSTOMER

Medical Devices

Biopharmaceuticals, Tissue, and Biologics