AOAC 2018 Preliminary Program

3:00 pm – 4:30 pm Symposium: Qualification of Certified and In-House Botanical Reference Material for Intended Use in Botanical Identification Beyond the proper use of botanical reference materials (BRMs) in the dietary supplement industry, the qualification of in-house BRMs is critical for routine QC practice, especially for the identification of botanical extracts as the standardiza- tion of botanical extracts is a concern. The compendia and commercial BRMs are important and convenient to use for identification of botanical ingredients if they are standard- ized to the definition. The compendia BRMs are created to be robust and reliable. Many techniques for the qualifica- tion of BRMs, such as DNA, HPLC/HPTLC, and NMR been used in processing the qualification of Reference Materials. However, only limited BRMs are available from USP, NIST or commercial sources due to the diversity of botanicals and botanical extracts in this industry. The creation and qualifica- tion of in-house BRM is essential to the industry. Regulations on Reference materials are available, including — ISO Guide 33:2015 Good practice in using reference materials 34:2009 General requirements for the competence of reference material producers, and 35: 2006 General and statistical principles for certification. But the standard procedures for generating certified and in-house BRM are not clear. This session will cover important considerations in the qualification of an in-house BRM to get a defined quality for intended use as well as maintaining the integrity of the reference material. It will include the topic of the selection of reference material candidate material, the authentication of the identity of the selected candidate, the characterization of the reference material in terms of integrity and the stability qualitatively and quantitatively. CO-CHAIR: Yanjun Zhang, Herbalife International of America Inc. CO-CHAIR: Joseph Betz, National Institutes of Health CO-CHAIR: Laura Wood, U.S. National Institute of Standards and Technology • Stephen Wise, National Institutes of Health The World of Reference Materials: Development, Characterization, and Various Uses • Steven Newmaster, University of Guelph The Assemblage of a Vouchered, SBRM DNA Library for Botanicals • Catherine Rimmer, U.S. National Institute of Standards and Technology Qualification of NIST Botanical Reference Materials • Maria Monagas, U.S. Pharmacopeia (USP) USP Botanical Reference Standard Development • Congmei Cao, Herbalife International of America Inc. Qualification of Certified Herbalife In-House Botanical Reference Material

material. This session will provide an overview of different types of reference materials for dietary supplements and natu- ral products, explain principles of their development, as well describe their critical roles quality assurance, research, and accreditation activities. CO-CHAIR: Adam Kuszak, National Institutes of Health CO-CHAIR: Catherine Rimmer, U.S. National Institute of Standards and Technology • Neal Craft, Craft Technologies, Inc. Reference Materials for Nutritional Analysis of Clinical Samples • Bailey Ireland, Eurofins The Role of Reference Materials in Method Validation and Laboratory Accreditation • Quan Can, National Institute of Metrology, People’s Republic of China Development and use of CRM for traditional medicine applications Symposium: ISO 17025:2017 — It’s a Whole New Ballgame... Or is it? The long-awaited revision of ISO 17025 has created a bit of the fear of the unknown. To start with the entire standard has been reorganized leading many to wonder what is hidden in this seemingly-jumbled document. There is fear that one will have a tough time finding things and that others might be missed. While it is understandable that changes can lead to additional stress, there is a lot that has stayed the same. While many of the requirements are the same, though in different places throughout the new standard, some new concepts have been added. One significant difference though is centered around risk. This symposium will provide an intro- duction to the concept of risk and how it is applied under the new standard. Next is decision rules and one application of measurement uncertainty. We will dive deep into the measure- ment uncertainty and how it applies to decision rules. Finally the concept of sampling will be discussed including changes to the approach. Attendees will gain new insight into the revi- sions and get ideas for implementation that can be applied to their own quality systems. CHAIR: Brad Stawick, SGS North America, Inc. • Brad Stawick, SGS North America, Inc. Introduction to ISO 17025:2017 — What Has Changed and What Hasn’t? • Jane Weitzel, Consultant Decision Rules — Don’t Forget the Measurement Uncertainty • Roger Brauninger, A2LA - American Association for Laboratory Accreditation Risk and its Role in the New Standard The Role of Certified and In-House Reference Materials in Laboratory Quality Control System • Roger Brauninger, A2LA - American Association for Laboratory Accreditation

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