Effective Risk-Based Applications of Drug cGMPs and Validation Requirements of Cosmetics and OTC Drug Products

This course provides the tools for risk-based implementation and continuous compliance with drug cGMPs for OTC drug product manufacturers, including cosmetic manufacturers that also produce OTC drug products.  The course also covers regulatory expectations as contained in U.S. and International guidelines.  This training prepares attendees to assess their current compliance status, develop strategies and plans for remediation of identified gaps and execute a plan to achieve compliance by initially addressing higher risk items within a reasonable time frame. 

Attendees are given the opportunity to apply what they have learned during two workshops.  In addition, ample time will be provided to address specific problems and questions of individual participants.  Individuals will also have the opportunity for one-on-one consulting with the Course Director during course breaks and in the evenings.