An NSF International Company Mr Rocco R. Duran
Executive Director
- [email protected]
- + 1 857 277 0060
Rocco R. Duran is a pharmacist by education who has worked in the pharmaceutical industry for the last 32 years. Rocco has been employed by four major and global pharmaceutical companies and has held roles of increasing responsibility in the areas of pharmaceutical development, production, production engineering, quality assurance, quality control and regulatory compliance.
He has experience at a senior leadership level for the development and implementation of global operations quality strategies. He has experience with multiple pharmaceutical dosage forms, has lead quality teams through lean and six sigma efforts and has been responsible for quality assurance and quality control improvement initiatives.
Rocco has been responsible for the successful preparation and handling of multinational regulatory inspections from regulatory agencies such as FDA, MHRA, MPA, Health Canada, ANVISA, Japan and other second and third world countries as well as the management of 483’s, Warning Letters and the involvement with a whistle-blower lawsuit.
He has lead and been involved with efforts related to development of a Latin America Regional Quality Network and global efforts related to continuous quality improvement, quality system management, quality risk management and culture of quality. He has also been a champion for efforts to improve performance and control within the pharmaceutical supply chain including initiatives related to good storage and distribution practices.
A member of ISPE and other pharmaceutical and quality organizations, Rocco has been a guest speaker at ISPE conferences on the topic of quality risk management and at an ISPE Sponsored FDA CDER chemist training.
