Why Should You Attend:
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 before an FDA audit occurs. There are several problems with this approach, however. The auditors may not fully understand the regulations and may not have been trained in audit techniques. Another impediment is that an internal auditor is monitoring his/her friends. It is very difficult to point out errors committed by a friend since by calling attention to a lack of compliance may be interpreted as "telling on" the friend and possibly causing a problem for them.
This program will cover two major topics. First, we will discuss auditing. This portion will show what an auditor does and how an audit is conducted. We will also stress the difficulties faced by an auditor who is from within the organization being audited.
The second portion of this program will present an overview of the various GMP regulations that a manufacturer must work within. Lastly, we will identify the most commonly cited GMP violations and show how they are found and identified. Topics included in this presentation include:
James R. Harris, 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. One of the services that were highly sought by clients was assistance in conducting clinical trials. He has assisted many firms in designing the trials, writing trial protocols, selecting a CRO to perform the project management, and oversee the trial process.
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