Speaker Profile

Shib Mookherjea

Consultant,Quality Systems, Validation Expert, ValQual International, Inc

Dr. Shib Mookherjea is an internationally acclaimed speaker and consultant. He has extensive experience in R&D, Quality Assurance, and Quality Management. During the past 25 years, he has held both Senior Scientist and management positions within the R&D, QA, and regulatory areas with companies such as Johnson and Johnson, Colgate-Palmolive, BASF, and Troy Corporation/Troy Biosciences, CRO’s and governmental organizations. He is a recognized expert in the fields of validation, QA, and QC in both the pharmaceutical and process industries. In addition to having served on many international scientific task forces, workgroups, and committees; Dr. Mookherjea is a lead auditor of ISO-9000 and has conducted many GLP and GMP audits. Presently, he conducts GMP, GLP, OECD, and global ISO, as well as quality systems-related seminars, workshops, and short courses independently in numerous countries in collaboration with many recognized institutions and organizations in several countries (ACS, AOAC, EAS, AAPS, GDCHe, Sindusfarma, CEDECAN, CPBA, WHO, ISO, etc.)

Dr. Mookherjea has a proven track record in training, complete project management, problem solving and extensive accomplishments in the areas of Pharmaceutical Development, Marketing, Quality Assurance, Quality Control, Process Upgrade, Analytical Support for Stability Studies, Environmental Studies, Worker Exposure (OSHA), and Validation in the Laboratory. He also has been consulted with for academic, corporate, and private industries for his considerable expertise and insight, and relied upon in critical situations for expedient solutions and proactive responses. The unique training activities he offers are largely focused on the development of QA/QC, R&D scientists, managers, and other professionals from several disciplines within an organization. He has assisted countless professionals in the process of understanding and meeting the ongoing challenges of Regulatory Objectives, Quality Systems and Compliance Issues. Many of his unique modalities and concepts have been useful in academic development and in various research institutes as well.

The training modules and short courses personally developed by Dr. Mookherjea have been presented to thousands of attendees and target audiences over the last 20 years in several countries, across the related industries. As they have evolved and changed, so have the innovative and ground-breaking courses created by Dr. Mookherjea. Presently focusing on these activities as Principal of ValQual International Inc., Dr. Mookherjea provides consulting and training services to the Pharmaceutical, Biotech and Process industries globally.

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