February 8-10, 2011: Section 111 GMP Training Seminars. Salt Lake City Marriott City Center, Salt Lake City, UT, USA. These 2 seminars, conducted by NSF-DBA, provide state-of-the-art understanding and the required tools to meet your GMP compliance responsibilities.

Course 1: 21 CFR 111 Dietary Supplement GMP Overview on February 8-9. These guidelines are intended to be applicable to dietary supplements as defined and covered by the FDA's Code of Federal Regulations Title 21, Part 111 [Current Good Manufacturing Practices in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements] also known as 21 CFR Part 111, but may also be applied to dietary ingredients and other components. This course provides an in-depth review of the guidelines and provides case-studies involving the review of recent Warning Letters initiated to Dietary Supplement companies for non-compliance to 21 CFR 111 GMPs.

Course 2: SOP and Record Keeping for Compliance to 21 CFR 111 on February 10. Through the Current Good Manufacturing Practices for Dietary Supplements Regulations that were enacted in June of 2007, the FDA has established industry-wide standards to ensure identity, purity, strength, and composition of manufactured dietary supplements. The regulations are specific with respect to the procedures that must be in place, and the records that must be maintained in support of those procedures; however, they are somewhat vague and don’t offer clear guidelines for achieving compliance. In addition, companies are left to determine the level of compliance that they need to put in place, and the frequencies for tasks that must be performed in order to continue to comply with the regulations.

More information is available at: www.nsf-dba.com/eu-pharma/usa_res_course_diary.