Pharmaceutical Consultant – Quality & Compliance
Dr. Richard Poser has been both receiving and conducting audits in drug, laboratory, device, software and manufacturing environments for over 25 years and teaches from personal experience. He has been Director of Laboratories in both R&D, clinical phase and commercial operations in drugs and medical devices, and has been a consulting quality systems advisor or auditor to dozens of diagnostic, biologics, pharmaceutical and medical device manufacturers including many of the Fortune 500. Following many inspections he has been retained to design remediation and corrective actions to attain regulatory compliance. Dr. Poser is President and Lead Auditor for First Quality Inc., a consulting firm which has conducted hundreds of 3 rd -Party audits for laboratories, data systems and manufacturing operations. He has special expertise in data systems and 21CFR Part 11 compliance, and has worked with dozens of companies to validate systems used in regulated laboratories.
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