Biography:

Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical, and managerial experience in developing and manufacturing 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 many major pharmaceutical and biotechnology companies in the US, Central America, Mexico, and Europe. He has worked with or assisted way more than dozens of companies with the establishment of controlled document/quality systems, FDA/EPA briefing and submittal documents, and project management of several multi-million dollar projects, including design, start-up, and validation to ensure fast-track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning, and verification, 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. The FDA and other regulatory agencies have received and accepted each of his projects. Jerry is considered an expert in almost all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on various topics. His work has yet to receive a 483 but has corrected and prevented many, along with Warning Letter remediation.