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Talent
Description
Meet the Tougher U.S. FDA CGMPs
Speaker: John E. Lincoln 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. Course Description:
Tougher FDA CGMP Compliance Audits and enforcement require more effort from industry. This webinar will examine recent statements by and evidence of the Agency becoming tougher in its expectations for and audits of the regulated medical products industries and their compliance to the cGMPs.
It will examine how these goals of the Agency have translated into action over the past several years: The changing focus of QSIT re: medical devices, and ICH Q8, Q9, and Q10 re: pharmaceuticals; Multi-site company operations, and major changes in supply chain requirements; Increased validation expectations; Trends evident in 483 observations, Warning Letters, and recent major industry failures; Emphasis on proving a company is "in control" to an investigator's satisfaction; the negative role of "entropy", and proactive and reactive Warning Letter avoidance techniques. Course
Objective:
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. Course Outline:
Target Audience:
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To Enroll for This Program today please click hear
Thank you & Regards,
Kevin Roberts,
Training Manager,
kevin.roberts@complianzworld.com
Call us at this Toll Free number: +1-866-978-0800
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Presented By
10:00am to 11:30am
General Admission: $199.00
21+
10 +1-866-978-0800 PAST EVENTS
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Thursday, March 5th
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