Biography:

George Bernstein, Ph.D., is a Principal with Double Dragon Consulting, Inc., a consulting firm with a network of Subject Matter Experts located in the US, Europe, and Asia Pacific (China, India). Dr. Bernstein has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, Dr. Bernstein has consulted internationally with major pharmaceutical companies. He has lectured on quality systems and root cause analysis to industry trade groups, quality organizations, and at Interphex. In 1998, Dr. Bernstein led the development, validation, and implementation of an electronic batch record system for a client. This system is still in use today.

Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work which ranges from GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the US FDA.