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Biography

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.

Abstract

Key Topics:
An overview of global compliance issues, global harmonization initiatives, role of ICH, relevance of Validation activities & the Paradigm Shift
Quality Control and Quality Assurance in analytical, R&D, QC, PD laboratories: General considerations, quality systems, QC procedures, QA oversight, process control measure.
•Perspectives of ICH ISO integration: ICH Q1 (stability studies), Q2 (Analytical Methods), Q3 (Impurities), Q7 (Pharma Process), Q9 (Risk Assessment), Q10 (Quality Systems), etc.
•Measurement, measurement uncertainty, measurement resolution, total error, and bias
•Analytical measurement: Process Model & Risk Assessment (REMS)
•A generic, science based outline of Methods Development & Validation [ab initio]
•Perspectives of QbD, PAT Directives: On-Line Measurements vs. Off-Line
•Validation parameters, their generic definitions, and their practical applications to various methods
•Highlights of the guidelines derived from International standards – ISO 17025, AOAC, WHO, GLP, GMP, EMEA, USP/EP/JP, etc.
•Standardization/qualification/verification/validation: The implicit continuum
•A generic approach to analytical method optimization during development
•Some case histories and applications for improvement of validation characteristics
•Data integrity and statistical evaluation of analytical data: SQC, control charts
•Methods development and optimization in HPLC, UV-VIS including assessment of peak purity, as examples of the most recent techniques widely used in analytical laboratories
•Methods validation & regulatory submissions: IND/ ANDA/ NDA/ CMC
•Method development and validation by examples (group exercise): How to systematically develop and validate an assay for a trace component in a very complex sample matrix, develop the schematic template of a validation protocol
•Perspectives of qualification of various analytical systems (IQ, OQ, PQ) GAMP, USP

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