Nada Kuganathan

Nada Kuganathan

Nada Kuganathan is a seasoned Quality and Compliance professional with extensive experience, knowledge and proven track record for more than 30 years in the pharmaceutical industry. This experience included branded, generic, contract and consulting business environment in QA, QC, Compliance, Vendor Qualification, Training, and in the global arena. Nada is currently the president & principal consultant of Enkay Consulting Services Inc., CA, USA. In this capacity, Nada has successfully completed several consulting activities with large, medium and start-up pharmaceutical companies related to Quality, Compliance, Vendor Qualification & Supplier Audits, Training and US FDA Inspection Readiness. His work involves a variety of dosage forms of drugs, combination products (both sterile and non-sterile), biologics, and OTC.

Prior to consulting, Nada served as Executive Director, Global Compliance with Actavis (Formerly Watson and now Allergan). During his career in management positions in QA and Compliance areas, he had conducted numerous strategic quality compliance audits in the lead capacity which included numerous supplier/contractor audits such as API, cell banks, excipient, contract manufacturing, laboratories, R&D facilities, and distribution centers for small and large molecule pharmaceutical products around the world. This also included due diligence audits for product and company acquisition. Nada has actively participated in leadership roles in successful strategic vendor qualification projects at a global level.

He was a member of the board of directors & chair of the evening seminar committee of Pharmaceutical Sciences Group of Canada (1999-2001) and also a working group member of the auditor qualification team for Rx 360, an international pharmaceutical supply chain consortium (2011-2012). Nada has delivered numerous presentations to pharmaceutical and API industry professionals on QA, Compliance, Auditing, Validation and Microbiology/Aseptic topics via leading professional organizations such as PDA, ISPE, IVT, CBI, SWE, PSG in the US, Canada, Europe, and India.