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Howard T Cooper
has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. After leaving the brewing industry, he joined a medical device contractor when the Medical Device Amendments were being finalized. His first challenge was to establish a GMP system that met the needs of the large medical device clients that contracted with the company to produced finished medical devices. This very successful challenge led him to focus on startup quality systems and to mitigate failing quality systems.
This experience includes:
Designing and implementing Quality Systems from scratch in several startup operations.
Managing both single and multiple site quality operations
Assisted in revamping failing quality systems under warning letters and consent decrees
Advised large FDA regulated companies to improve their quality operations.
21 CFR Part 11
Drug Master File
Good Manufacturing Practice
Clinical Data Management
Active Pharmaceutical Ingredient
Good Clinical Practice
Corrective and Preventive Action
Medical Devices Recalls
Medical Devices Directive
Medical Device Listing
Medical Device Safety
Medical Device Reporting (MRD)
Design History File
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