UNPA to Host Industry Training Courses

The United Natural Products Association (UNPA; Salt Lake City) and NSF-DBA (Ann Arbor, MI) are co-presenting three industry training courses next week at the Salt Lake City Marriott City Center:

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 noncompliance, 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 all sizes of dietary 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 t0 develop a ‘guideline’ for industry that would provide them with tools for conducting stability studies and implementing stability programs 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.”

UNPA members are eligible for 10% discounts. To register, contact Ashley Sanchez or Jennifer Bell by e-mail or phone: asanchez@nsf.org or 734/214-6201; jbell@nsf.org or 734/827-5675.