Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval 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 also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training.

Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered an expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation

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Jerry Jerry

Speaker: Jerry Dalfors
Duration: 60 Minutes
Product ID: 700176

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CAPA Training and Causes of Warning Letters due to Lack of Comprehension

CAPA (Corrective and Preventative Actions) did not originate in the Pharmaceutical and Medical Device industry or the Automobile Industry as most folks post on the Internet.  The program to ma more...

Jerry Jerry

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700166

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Medical Device Reporting (MDR)

Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also rep more...

Jerry Jerry

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700072

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Mathematics of Terminal Sterilization - Survival vs Overkill Approach.

Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality). Some extreme th more...

Jerry Jerry

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700057

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PRINCIPLES, AND PRACTICAL ASPECTS OF LYOPHILIZATION TECHNOLOGY

Lyophilization, commonly referred to as freeze drying equipment, is the process of removing water from a product by sublimation and desorbtion.  This process is performed in lyophilization equ more...

Jerry Jerry

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700048

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Process Validation in Statistical Process Control

The ultimate goal of FDA Process Validation is to ensure continual assurance that the process once initially validated (PQ now PPQ) and submitted for FDA/EU approval remains in a state of control b more...

Jerry Jerry

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700029

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Generation of Controlled Documents and Related Training

The purpose of this webinar is to provide the topics and basic instructions needed to establish the good documentation practices training needed to meet or exceed compliance expec more...

Jerry Jerry

Speaker: Jerry Dalfors
Duration: 60 Minutes
Product ID: 700006

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CAPA Training and Causes of Warning Letters due to Lack of Comprehension

CAPA (Corrective and Preventative Actions) did not originate in the Pharmaceutical and Medical Device industry or the Automobile Industry as most folks post on the Internet.  The program to ma more...