Preparing for Foreign FDA Inspections

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. Saxon has personally attended 90 FDA inspections of foreign facilities and another 15 inspections by other regulatory agencies (TGA, WHO, EDQM). His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks.

About the Presenter

Peter Saxon has extensive experience in assisting pharmaceutical companies to prepare for FDA inspections of API and finished dosage plants for the U.S. market. He brings 45 years of experience in technical operations, materials management, and business development background in the pharmaceutical industry. His expertise includes pre-inspection audits, Drug Master File (DMF) preparation, equipment, cleaning, computer and process validations as well as QA training. A consultant since 1993, he has assisted major US pharmaceutical companies through FDA consent decrees and guided foreign API and finished dosage manufacturers through FDA inspections. Prior to consulting Saxon served in management roles with Ciba-Geigy Corporation, including stints in Cairo, Egypt, and Basel, Switzerland. Mr. Saxon holds an MBA from Rutgers University, and a BS in chemical engineering from Manhattan College, Riverdale, NY. He is fluent in German and has a working knowledge of Spanish, French, Arabic, and Chinese

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