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August 23, 2011
PHOENIXVIRGO announced the official GMP (good manufacturing practice) training program for SupplySide West, Oct. 10 to 14 at the Venetian & Sands Expo in Las Vegas, will be developed and presented by NSF-DBA.
The first course, 21 CFR 111 - Dietary Supplement GMP Overview," is scheduled for Monday, Oct. 10 from 8 a.m. to 5 p.m. and Tuesday, Oct. 11 from 8 a.m. to noon. This training 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. This course includes a comprehensive review of the regulations and an interpretation of each subpart to provide a thorough understanding of how to apply the principles to a companys specific situation. Registration for this course is $1,095.
The second course, GMP Vendor Qualification & Auditor Training," will be held on Monday, Oct. 10 from 8 a.m. to 5 p.m. and on Tuesday, Oct. 11 from 8 a.m. to noon. Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. This course will offer guidance on how to achieve the critical requirements in qualification in ways that will enable compliance with GMPs and make the most efficient use of resources. Other topics include requirements under the GMP regulation, testing for identity and other appropriate chemical, physical, and microbiological properties, qualifying a third-party laboratory to conduct testing, supplier/vendor qualification, auditor training and much more. Registration for this course is $1,095.
The third course, Stability Program Development," is scheduled on Monday, Oct. 10 from 8 a.m. to 5 p.m. The training program will dissect the industry guideline for conducting stability studies and implementing stability programs in your company. Real-world scenarios will be discussed and exercises in designing the appropriate specifications for a stability study will be conducted. Registration for this course is $895.
The fourth course, Batch Production Records Dos and Donts" will be held on Tuesday, Oct. 11 from 8 a.m. to noon. Formal Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) have long been required in the pharmaceutical world, but the dietary supplement GMPs bring these requirements to this industry as well. Deficiencies in MMRs and BPRs are among the most frequently cited during audits or inspections, including those from FDA. This course will examine common issues and pitfalls with MMRs and BPRs and provide specific guidance on how to avoid these problems. Best practices will be highlighted to enable your batch records to withstand audits and inspections, and also streamline and improve your internal operations. Registration for this specialty course is $599.
The content for the four courses is based on the results from initial FDA GMP inspections. The courses are geared to professionals involved in dietary supplement manufacturing, labeling, management, auditing, quality control/assurance, laboratory operations and regulatory affairs.
Registration includes training and presentation materials, lunch and a Certificate of Attendance (to be provided upon course completion). Course attendance applies toward the requirements for receiving the Dietary Supplement Quality Professional (DSQP) Certification through the NCNPR of the University of Mississippi. Click here to see training course descriptions, outlines, trainer bios and registration.
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