Winning Strategies for Successful US FDA Inspections: Conducting an Effective Mock Pre-Approval Inspection & Implementing Robust Remedial Measures

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, Validation, and Training in the global arena with good understanding of cultural differences.

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, Microbiology and Training areas. This not only included Vendor Qualification, strategic cGMP Gap Analysis, Mock PAIs, Due Diligence audits, but also to support pragmatic and robust implementation of remedial measures, Site preparation for US FDA compliance & remedial measures for 483s and warning letters in the global arena. His work involves a variety of dosage forms of drugs, combination products (both sterile and non-sterile), OTC and dietary supplements.

Prior to consulting, Nada served as Executive Director, Global Compliance with Actavis (Formerly Watson and now Allergan). Nada held management positions in quality, compliance, microbiology and technical projects with increasing responsibilities in pharmaceutical industry with hands on experience. During this period, he had conducted numerous strategic quality compliance audits in the lead capacity which included Mock PAI, cGMP gap analysis, corporate internal audits, and project implementation, vendor/supplier audits such as API, cell bank, excipient, contract manufacturing, laboratories, R&D facilities, and distribution centers for small and large molecule drug products around the world. This also included due diligence audits for product and company acquisition.

Nada had delivered several presentations to pharmaceutical industry professionals on QA, Compliance, Auditing & Vendor Qualification, Validation and Microbiology/aseptic topics via professional training organizations such as PDA, ISPE, IVT, CBI, SWE, PSG and other in the US, Canada, Europe and India.

Nada holds a Master of Science degree from University of London, England. He served in the Board of Directors of Pharmaceutical Sciences Group (PSG) of Canada from 1998 to 2000. He was the chair of the Seminar Committee of PSG, Canada in 2000. He also served as a working group member (2011-2012) for defining “Auditor Qualification” for Rx 360, an international pharmaceutical supply consortium.