cGMP PROFESSIONAL,SPEAKER,TRAINER,AND CONSULTANT FOR: 1.Quality system design 2.Process validation 3.CAPA 4.Change control INDUSTRIES:Pharma,Biomed,Med device

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

4. Biopharmaceuticals,
Tissue, and
Biologics