April 17-19, 2012: UNPA / NSF-DBA Training Courses. Salt Lake City Marriott City Center, Salt Lake City, UT, USA.

Corrective Action and Management (CAPA)
Tuesday, April 17, 2012

What You Will Learn:

• Scope and sources / inputs to an effective CAPA system within the FDA-regulated dietary supplement context
• Factors to help move your CAPA system toward being less reactive and more proactive               
• Common problems (and solutions) associated with implementing and maintaining effective CAPA systems               
• How the FDA concept and tools of risk management relate to effective CAPA               

FDA Inspection Readiness
Wednesday, April 18, 2012

What You Will Learn:

• The FDA inspection process in the context of producing and selling dietary supplements (or other FDA-regulated products)
  - Critical factors to consider and steps to accomplish well before any inspection ever takes place
  - How to effectively manage the process and issues that arise during the inspection to optimize the outcome
  - Essential elements of follow-up activities after an inspection to ensure a positive ending to this inspection and position your company for the next one

Stability Program Development
Thursday, April 19, 2012

What You Will Learn:

This training program will dissect the industry guideline while also providing real-world scenarios and exercises in designing the appropriate specifications for a stability study. Some other highlights include:             

• How to identify issues related to the physical, chemical, and microbiological characteristics of the components under long-term storage               
• Understand the impact that manufacturing, packaging, labeling, and holding/warehouse processes may have on the stability profile of products               
• How to ensure that the finished products have initial release specifications that help ensure compliance with long-term stability specifications and suitable overages               
• How to determine the stability of the finished product in the container-closure system that will be marketed               
• Review of any historical data related to the formulation or the container-closure system that may be relevant to the stability of the product               
• How to review applicable label claims related to stability aspects of the finished product to ensure that stability studies are designed to support these claims, as necessary               
• Understand the distribution (including transportation) and storage conditions that the dietary supplement will be subjected to over its shelf life and factor these conditions into the stability study as necessary               
• How to consider the suitability of accelerated stability studies on new product forms, as some components may react differently at increased temperatures or humidity levels than at ambient conditions               
• How to consider the potential for the formation of degradation products and set corresponding stability indicating specifications as necessary

More information is available at: http://nsf-dba.com/courses/schedule/2/dietary?topic=dietary.