The last few years have seen several major "names" in drugs and devices stumble over cGMP issues, resulting in multi-million dollar fines, recalls, lawsuits, and even possible criminal prosecution beyond the corporate "veil". This indicates an on-going, major shift in the emphasis of the U.S. FDA cGMP compliance expectations and resulting audits, also affecting clinical trial expectations, product submissions and company response requirements.
This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. The major failures of key industry "players" in pharmaceuticals, devices, as well as events in unrelated industries have caused the Agency to "get tougher on compliance / enforcement". The cGMP compliance audit, validations, 510(k) submissions / data, "better science", lifecycles, closed-loop CAPA, outsourcing / globalization and supply chain / control issues, and senior management, are all under more intense scrutiny.
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Recorded video session
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA