About Howard T. Cooper
As
a consultant, Mr. Cooper shares his 30 years of quality assurance
experience in the pharmaceutical and medical device industries by
helping smaller companies and startups to understand, develop, and
implement GXP quality systems. He has successfully designed,
staffed, and implemented several startup quality systems that
resulted in successful product launches. His leadership style
motivates personnel to understand the beneficial effect of the GXPs
for the company and its employees. He has the ability to assess
situations quickly and objectively by finding and focusing on
systemic failures.
Mr. Cooper has confidence in quality assurance’s role in shaping successful operations. Most importantly, he knows how to use his leadership abilities to build organizational relationships that make these systems operate effectively and efficiently in your organization.
Quality systems are preventative in nature, resulting in greater efficiency and effectiveness. He believes that compliance must be achieved through the quality system. Compliance outlines the requirements; quality systems make them happen.
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B.S. in Biology/Chem.
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Certified Biomedical Auditor
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Quality Manager and Quality Auditor
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Working toward Regulatory Affairs Certification (RAC)
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Member of ASQ, PDA, AAMI, MWSQA, and SQA
His technical education is further complemented by his Political Science degree, which helps him understand the regulatory process; his work toward an MBA helps him understand the business side.