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Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Healthcare Consulting: Strategic Planning, Product Development, and Product Launch
Expert has been providing expert strategic and operational advisory services to healthcare investors and development stage healthcare companies for nearly 10 years. He has been involved in direct healthcare management for over 15 years, and has been practicing medicine since…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Oxygen Therapy & Conservation, Biofeedback, Clinical Management Design, Electronics, & Prototyping
Expert L. Expert has extensive clinical experience in asthma management and served on the ATS Standards Committee for COPD (Chronic Obstructive Pulmonary Disease). He developed an asthma clinical guidance system, developed three biofeedback systems particularly for asthma. He also developed…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…