United Natural Products Alliance/NSF-DBA April 2012 training courses
April 17-19, 2012
Salt Lake City Marriott City Center
Salt Lake City, Utah
Corrective Action and Management (CAPA)
Tuesday, April 17
Every system has things that do not go according to plan and results that do not meet expectations. A cGMP system will have many sources of such issues: customer complaints, product non compliances, internal deviations from specified practices, supplier problems, and results from internal, second-party, or third-party audits. This course will focus on factors and techniques to enable you to turn these initially negative events into positive outcomes that will not only avoid recurrences of these problems, but strengthen your overall quality system.
FDA Inspection Readiness
Wednesday, April 18
This course provides attendees the tools necessary to successfully manage an inspection by the FDA. The implementation deadlines for 21 CFR 111 have passed, and the FDA is actively auditing dietary all sizes of companies involved in the manufacturing, packaging, labeling, holding and distributing of dietary supplements. Real-world examples will be provided and classroom exercises will be utilized that will take each participant through the different phases of an FDA audit, demonstrating tools and techniques for successfully managing an inspection.
Stability Program Development
Thursday, April 19
Although federal regulations do not require the use of dietary supplement product expiration dates, according to the Federal Register GMP Preamble, June 25, 2007, Volume 72 Page 34856, “when such dates are assigned they should be supported by data that qualifies the stability of the product.” A working group was established in 2009 to develop a “guideline” for industry that would provide them with tools for conducting stability studies and implementing stability program in their operations. The guideline is intended to provide practical guidance on what should be considered when developing voluntary written shelf-life study protocols to establish or confirm expiration dating of dietary supplements.