GLEN FEYE
Hauptberater

Erfahrener Berater in Qualitätssicherung, Qualitätskontrolle, und Zulassungs Angelegenheiten, mit eigenhändigen Erfahrungen mit US FDA in Bezug auf Produkt genehmigung und Compliance Angelegenheiten.

Bescheinigter Qualitäts Ingenieur mit 15 jähriger Erfahrung in allen Phasen der Produktentwickung, Herstellung, und Einführung von bioengineering, bio-pharmaceutischen und Medical Device Produkten.

Ausgezeichnete Kommunikationsfähigkeiten, Vorträge bei zahlreichen FDA Industriekonferenzen und Seminaren.

“Best Practices for cGMP Audits, PAI, and Corrective Action Plans”, Instructor for International Quality and Productivity Center-Center for Pharmaceutical Training: Chicago, IL. (Nov 18-19,2002), Princeton, NJ. (Dec 16-17, 2002), San Francisco, CA. (Jan 30 –31, 2003), Philadelphia, PA. (Feb 24 –25, 2003), Philadelphia, PA (April 28-29, 2003), Chicago, IL. (June 23-24, 2003), San Francisco, CA (July 28-29, 2003), Chicago, IL (October 28-29, 2003), and Boston, Mass (November 17-18, 2003)

Laboratory Compliance Seminar Series:“ Pre-Approval Inspections: Before, During, and After”, Institute of Validation Technology –San Diego, CA, October 12, 2001.

PAI 2001- Meeting Chair. “ Executing a Successful Re-Inspection Strategy Following an Unsuccessful PAI-Interactive.” Barnett International -Philadelphia PA, June 11-12, 2001.

Avoiding a Warning Letter, How to effectively prevent a 483. “ Executing a Successful Re-Inspection Strategy Following an Unsuccessful FDA Inspection-Interactive Session.” Institute of International Research- Philadelphia PA, September 18-19, 2000.

PAI 2000.:“ Executing a Successful Re-Inspection Strategy Following an Unsuccessful PAI-Interactive.” Barnett International -Philadelphia PA, June 11-12, 2000.

Avoiding a 483. “ Executing a Successful Re-Inspection Strategy Following an Unsuccessful FDA Inspection-Interactive Session.” Institute of International Research-San Diego, CA, November 4-5, 1999.

Pre-Approval Inspections:“ Executing a Successful Re-Inspection Strategy Following an Unsuccessful PAI.” And “Ask the Experts-Panel Discussion”. Barnett International -Philadelphia PA, June 17-18, 1999.

Haupt Assessor und Leistungssprüfer in allen Bereichen von Medical Devices, Biologischen, und Pharmazeutischen Zulassungsfragen.