Agenda eProgram
Discussion Summary and Speaker Presentation - Day 1 Discussion Summary and Speaker Presentation - Day 2
August 21, 2018: 8:00 am–5:00 pm EDT
August 22, 2018: 8:00 am–Noon EDT
Workshop Overview
Join USP and the U.S. Food and Drug Administration (FDA) for this co-sponsored event on DNA Standards for Botanical Identification.
The objective of this workshop is to provide a forum for discussion of recent developments in DNA technologies for botanical identification and to discuss stakeholder needs to implement DNA methods as a routine QA tool. The expected outcomes from the workshop are (a) to understand the regulatory approaches and experiences from the industry in starting to implement the new methodologies for botanical identification, (b) to gain an understanding of the strengths and limitations of the new technologies to produce suitable identification methods and ways to compare results, (c) to identify the potential solutions to the challenges
associated with voucher specimens and public databases, and (d) to identify stakeholder needs for validated DNA methods and the potential role for USP in providing testing methods and reference standards for the identification of botanical articles.
Keynote speakers include Damon Little, Ph.D., with the New York Botanical Gardens and Caroline Howard, Ph.D., with the British Pharmacopeia – National Institute for Biological Standards and Control.
In addition, Dr. Sara Handy with the FDA, will discuss genomic approaches to botanical identification and RT-PCR based detection of food allergens.
Topics
- Taxonomy, DNA analysis methods, Reference Databases
- Botanical supplements and the industry perspective
- Reference Materials and Validation
- Regulatory approaches and comparability testing
- Pharmacopeial perspectives for characterization
Who Should Participate
- Dietary supplements and food manufacturers
- QA/QC managers
- R&D scientists/managers
- Regulatory affairs specialists
- Contract labs
- Academic institutions
USP Education Course: Botanical ID Methodology Tests
August 22, 2018, 1:00–5:00 pm EDT
Register
Course Overview
This course offers an overview of the botanical identification methodologies codified in the USP General Chapters <563> Identification of Articles of Botanical Origin, <202> Identification of Fixed Oils by Thin Layer Chromatography and <203> HPTLC Procedure for Identification of Articles of Botanical Origin, and in USP monographs for botanical articles. The content of these chapters and their application to botanical identification will be discussed, and the USP philosophy of comprehensive evaluation of the botanical article quality, stemming from orthogonality of different identification methodologies, will be presented. Importance of macroscopic and microscopic assessments will be highlighted. Numerous USP monograph examples and case studies in which incomplete compendial evaluation could invite adulteration will be examined.
Who should Participate
Quality control personnel (manufacturers of botanical ingredients and dietary supplements), contract labs (testing services) technicians, chemists, quality assurance personnel, laboratory supervisors, QC and QA managers.
Learning Objectives
- Upon completion of this course, you will be able to
- Recognize the importance of implementing the procedures exactly as specified in the monographs to guarantee reliable identification of botanical articles
- Describe the requirements for testing botanical articles, such as HPTLC and HPLC
- Ensure that the system suitability tests satisfy the Acceptance Criteria
- Ensure proper use of USP Reference Standards for botanical identification
- Appropriately judge the results of the ID tests
- Identify the critical variables that may affect the test outcome
- Determine whether the outcomes meet the Acceptance Criteria
Pricing Information
Pricing Registration is payable by credit card only. Registration fee for the workshop includes one and ½ days of meeting materials, coffee breaks and lunches.
Advance registration will be available through Friday, August 17, 2018. After that date, registration will be
available on site for the Workshop Only at the USP Meetings Center starting at 8am, Tuesday August 21, 2018.
Cancellation and Substitution Policy
Cancellation must be received on or before July 31, 2018 (21 days prior to the event) via email to conferences@usp.org. Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to conferences@usp.org
Invitation Letters for Visas
USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.
Registration Questions
Please contact conferences@usp.org or +1 301-816-8130
USP Headquarters
12601 Twinbrook Parkway Rockville, MD 20852 United States
Phone: +1-301-816-8136
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