Location: Attend Live Webinar
Date:25-Mar-2015: 10:00 AM PST
Duration : 90 Mins

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: 
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.

Course Outline:

• U.S FDA Changes in Emphasis and Coming Trends Regarding CGMP Compliance
• Core Expectations
• QSIT and Q10 Focus;  and Q8 and Q9 "Lessons"   
• High Risk Areas
• The Supply Chain
• Validation -- New Directions
• The Multi-Site Challenge 
• What Constitutes "Proof"
• Addressing the On-site Audit, the 483s, the Remediation / Responses

 Target Audience:

•  Management staff
• operators in Pharma, Devices, 
• Dietary Supplements
• Biologics -- Life Science Industries

Please Click hear for More  Information

To Enroll for This Program today  please click hear

Thank you & Regards,

Sean Sharpe,

Training Manager,

sean@complianzworld.com

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