Dr. Shib Mookherjea

Dr. Shib Mookherjea

Dr. Shib Mookherjea, is the Principal of ValQual International, Inc. (www.valqlaintl.com) and is a globally acclaimed Speaker and Consultant. He has extensive experience in R&D, Validation and Compliance Issues for Pharma, Biotech and Medical Device Industries; Quality Assurance, Quality Management and Quality Control in Pharma and Medical Device.

He is an SME in the areas of Methods Development and Validation of Analytical Methods, QA / Conformity Assessment in the Analytical Laboratory, as well as Analytical Development; Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ); Laboratory (Methods, Systems, Equipment Qualification), and Drug / Devices Development. He offers Consulting / Advisory on various aspects of cGMP /GLP/ISO 13485, ISO 9001, CAPA. He also conducts various audits for GMP & GLP (FDA/OECD); ISO 17025; Pharmaceutical Development (ICH Q6, Q7A, Q8). He has conducted GLP Studies (FDA/FIFRA) and has conducted hundreds of training sessions, workshops and short courses in diversified forums (for both public and in-house companies) covering various aspects of Quality / QA / Validation for Compliance to cGMP/GLP/WHO/EMEA/ICH etc. over the last 30 plus years, both in the continental U.S. and abroad.

He is an SME in the areas of Methods Development and Validation of Analytical Methods, QA / Conformity Assessment in the Analytical Laboratory, as well as Analytical Development; Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ); Laboratory (Methods, Systems, Equipment Qualification), and Drug / Devices Development. He offers Consulting / Advisory on various aspects of cGMP /GLP/ISO 13485, ISO 9001, CAPA. He also conducts various audits for GMP & GLP (FDA/OECD); ISO 17025; Pharmaceutical Development (ICH Q6, Q7A, Q8). He has conducted GLP Studies (FDA/FIFRA) and has conducted hundreds of training sessions, workshops and short courses in diversified forums (for both public and in-house companies) covering various aspects of Quality / QA / Validation for Compliance to cGMP/GLP/WHO/EMEA/ICH etc. over the last 30 plus years, both in the continental U.S. and abroad.