Howard Cooper


H. Cooper

Howard Cooper, CQM, CBA, CQA

Senior Regulatory Consultant


Mr. Cooper has over 30 years of Quality and Regulatory Affairs experience in the Pharmaceutical, Biological, & Medical Device industries. His expertise includes directing quality activities, implementing Quality Systems “from scratch” for incubator, startup, and larger corporate clients, and auditing manufacturing operations to achieve compliance and effectiveness. His successful application of quality principles has resulted in a very unique and comprehensive approach to organizing, remediating, and improving quality systems to assure compliance with GMP and QSR regulations. This has resulted in the ability to assess situations quickly and to identify cost-effective plans to address any potential issues. Key features of the SRC approach is to assure company personnel are trained, and that Standard Operating Procedures are in place to assure Quality implementation in a cost-effective and ongoing manner.

Mr. Cooper has a B.S. in Biology/Chemistry. He is a Certified Biomedical Auditor (CBA), Quality Manager (CQM), and Certified Quality Auditor (CQA). He is a member of AAMI, ASQ, MWSQ, and PDA & SQA, and is well known for his corporate training and presentations at professional organizations.