is being presented by Dr. Ruth Ann Lee, Director and Executive Consultant, Scientific Consulting, with Beckloff Associates, Inc. and airs on Tuesday, April 20, 2010. For more details or to register, please visit our site at www.fxconferences.com
Compliance is not passive! The regulatory agencies expect you to continuously evaluate and monitor your state of compliance, maintain compliance, and ensure sustained compliance. By understanding the interplay of regulations as the drug substance and drug product transition from lead compound through final commercialization, a drug development program can be optimized to prevent delays that can result in lost time, delayed return on investment and a shorter market life cycle.
This audio conference provides an overview of the regulatory compliance requirements through the various phases of product development. The speaker discusses the take-away message from current FDA compliance activities and present options to prevent, respond, and remediate compliance issues as necessary.