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"Nalini brings with her an educated and informed perspective as well as a refreshing attitude, which makes the class interesting and lively."
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S.W., Documentation Specialist, Alkermes, Inc.
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Nalini D. Lebzelter served as a Consumer Safety Officer for the Chicago District of the Food and Drug Administration from 1990 to 1997. In that capacity, she conducted cGMP, Pre-Approval, 510(k), Application Integrity Program, and Bioresearch Monitoring inspections. She also co-chaired Chicago District Drug Team and served on the training committee that coordinated technical exchanges between Chicago District investigation personnel and Abbott Laboratories, as well as other companies in the district. From 1998 to 2003, Nalini served as Project Training Officer for the Office of Regulatory Affairs in Rockville, Md. In this capacity, she developed and delivered training programs for FDA personnel. This experience helped create critical connections with most of the FDA National Expert cadre, various Regional Experts, and various headquarter personnel. The courses included mainly pharmaceutical subjects in addition to industrial sterilization of drugs and devices, orientation to international inspections, and quality auditing.
From 2003 to 2005, Nalini served as Director of Internal Audits for the Corporate Regulatory and Quality Science Division of Abbott Laboratories, managing and training corporate auditors on how to audit from the FDA point of view. She contributed her perspective in response to various FD-483s, Warning Letters, CAPAs, and investigations across all product lines. She also trained groups within the company with regard to the FDA perspective on various internal auditing strategies.
Pharmaceutical Training Institute contracts Nalini to present a number of courses, including Conducting Internal Audits, Implementing Good Documentation Practices, Pharmaceutical Water Systems and Annual Product Review.
Nalini holds a bachelor of science from Purdue University with a degree in food science. Nalini's broad governmental and industry contacts allow her to tap into a wealth of expertise. CCL works closely with select independent consultants with FDA experience to handle larger projects efficiently and cost-effectively.
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