Speaker Profile

James Harris
President, James Harris Associates Inc.

Dr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During his tenure in the pharmaceutical industry, he was very active in industry groups. He served on the PMA's Validation Advisory Committee and was chairman of the Computerized Systems Advisory committee where he wrote the original guideline on computer validation and negotiated its acceptance with FDA. While consulting, he and his consulting teams have assisted numerous clients around the world with validation of their manufacturing processes.

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GMP Auditor Training for Pharmaceutical Companies

Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal GMP audits in order to find and correct areas where the firm is not in full compliance with the GMP regul

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Project Management for Phase l & ll Clinical Trials

Before a pharmaceutical product can be approved for marketing in the United States, it must be tested clinically on human patients. Three levels of testing are defined with each level having different goals and number of patients.

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Process Validation for Drugs and Biologics

Every pharmaceutical manufacturing process is a batch process that consists of discrete steps. Each of these steps involves the use of specific equipment and its operation in a specific manner for a specific length of time.

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FDA Inspections: What to Expect and How to Prepare

When an FDA agent arrives at the front door of your manufacturing site, he fully expects to be greeted promptly and be given full access to any part of the facility and all records covering manufacturing including raw material specifications, approved su

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