---

Recorded James Harris 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 suppliers, vendor audits, all analytical results run to establish raw material acceptability, in-process labeling and status identification for every container within the facility, master records, batch production records including what lots of raw material were used, detailed records of manufacture, in-process quality records, etc. Recorded View Anytime  Duration:60 Minutes $295.00 James Harris 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. Recorded View Anytime  Duration:60 Minutes $295.00 James Harris 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. Recorded View Anytime  Duration:60 Minutes $295.00 James Harris 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 regulations. Recorded View Anytime  Duration:60 Minutes $295.00 << >>