Speaker Biography
Paul D'Eramo
Paul D'Eramo is Executive Director, Quality and Compliance worldwide for Johnson & Johnson. In that position, he is responsible for regulatory outreach and compliance oversight for the Johnson & Johnson family of companies. His compliance role involves partnering with J&J operating companies to resolve quality and regulatory compliance issues, and supporting initiatives involving new facilities, new products, and regulatory inspections. As part of his outreach duties, D'Eramo works with industry trade associations and regulatory agencies to develop new guidelines and regulations. He is a past Chairman of the ISPE Board of Directors and is currently the Chairman of the Technical Documents Committee, a member of the ISPE Regulatory Affairs Committee and the GAMP® Council. D'Eramo has been a speaker at numerous industry symposia in the US, Europe, and Asia, and has organized several joint industry/FDA training initiatives. Before joining J&J in 1997, D'Eramo worked for the FDA for 20 years as an investigator, compliance officer, regional drug specialist and Director of the Regional Pre-Approval Inspection Program. While at FDA, he was instrumental in forming the partnership between ISPE and the FDA which lead to the creation of the Baseline® Pharmaceutical Engineering Guides and the SUPAC "Similar Equipment" Addendum. For these efforts, he was awarded the ISPE Professional Achievement Award and Vice President Al Gore’s "Hammer Award" in 1997. D'Eramo received his BS in pharmacy from Rutgers College of Pharmacy and is a registered pharmacist in New Jersey