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Shib Mookherjea has a proven track record in analytical problem solving, R&D and extensive
accomplishments in the areas of Pharmaceutical Development, (ICH Q6, Q7A, Q8), Management
of QA/QC, Process Upgrade, CpK monitoring, PAT applications, Validation in the Laboratory
(Methods, Systems, Equipment Qualification), and support for dosage forms, in process materials,
excipients, DS, DP, medical devices, etc. He has held Management and supervisory positions within
Pharma, Biotech and other companies including Colgate Palmolive, Johnson & Johnson, Troy
Corporation, BASF & CRO/CMO Laboratories. Dr. Mookherjea is a highly-recognized speaker and is
the Principal of VQI.
Time tested coordination and leadership ability paved ways to build and develop functional groups
from the ground up, while ushering in systems, procedures, documentation and implementation of
quality systems (GLP, cGMP, ISO 17025) and other international standards for regulatory compliance.
Such challenges have been successfully met in various corporate settings by providing the needed
training and guidance, utilizing the world-wide network of scientific professionals that remain an
excellent source of reference and assistance in problem solving.
Dr. Mookherjea provides global training and consulting in areas of Validation, Methods & Audits for GMP, GLP (FDA/OECD)
ISO 17025, TQM, ISO 9000, Laboratory QA, and Accreditation. He is part of the continuing education faculty of the
American Chemical Society, EAS, CFPA and other international training organizations.