Who Should Attend

This two-day course is designed for those who manage, audit or oversee manufacturing of OTC drug products and for cosmetic manufacturers with OTC drug products (no dosage) performing their operation under a drug cGMP environment.  It will also be beneficial for those involved in Quality Systems and/or assigned with quality unit responsibilities at manufacturing facilities.

This includes, but is not limited to, professionals in Research and Development for the Process and Analytical procedures, Quality Control, Quality Assurance, Manufacturing, Engineering and Validation groups. The course will also benefit personnel in other departments who interact with the Manufacturing and Quality functions at the facility.



Learning Objectives

Upon completion of this course attendees will have a clear understanding of regulatory agency expectations for the manufacture of Cosmetic Products in comparison to OTC Drug requirements.  Additionally, participants will gain the background knowledge necessary to effectively implement drug-based good manufacturing practices and controls within their operation including the application of validation requirements.  Attendees will understand how to apply a risk-based approach for planning and implementing drug GMP/Quality systems, as well as, refining procedures within the validation program by addressing areas/systems with the highest impact on product quality.

Attendees will also learn how to apply the family product grouping approach to simplify validation procedures while maintaining compliance and developing a long-term quality program.



Course Description

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.

Additional benefits of this class include:

• All participants receive a Resource CD with Key Guidance Documents, Quality/Validation Procedure templates, a Validation Master Plan template and Protocol templates
  
  
• Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings