Jerry Dalfors

Speaker Profile :

Mr. Dalfors has had extensive (40+ years) consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. Prior to his current position as Principal, JD Technologies, he held management positions with major pharmaceutical and biotechnology companies as Div. Dir., Pharmaceutical Operations; Dir., Technical Services; Validation Manager; Marketing Manager; Project and Process Engineer, and Quality Assurance Testing Manager. Since then he has assisted more than a two dozen clients with the establishment of controlled document/quality systems, FDA briefing and submittal documents, managed several multimillion dollar validation projects, led facility and process design teams to assure fast track license by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which have been received and accepted by the FDA and other regulatory agencies. Is considered and expert in most all aspects of the biopharmaceutical industry.

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Medical Device Reporting (MDR)
Description of the topic: Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or con..

Live Session By Jerry Dalfors On Friday 4th of October 2019 10:00 AM PDT | 01:00 PM EDT
CAPA Training and Causes of Warning Letters due to Lack of Comprehension
A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also..

Live Session By Jerry Dalfors On Friday 20th of September 2019 10:00 AM PDT | 01:00 PM EDT