Microsoft Word - SPDS_0918_ERP-Proposal-07-11-2018DMC

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Statement of Expertise  I have extensive experience in nutrients and bio‐active method development, validation for the last  20 Years  Sr. Staff Review  Dr. Joseph has been very active with nutrient and vitamin analysis, most notably within SPIFAN.  He  has been a method author, and was chair of the SPIFAN Biotin Working Group.  He is active on SPDS  working groups and is a member of ERPs for SPDS as well as for dietary starch and fiber.  He has only  applied for the SPDS Vitamin B 12 ERP.  Staff Recommendation  Recommend for the SPDS Vitamin B 12 ERP.  Statement of Expertise  I am an analytical chemist with over 29 years of experience, particularly in HPLC, GC and SPE. I have  extensive experience in the application of liquid chromatography in the fields of food safety and  quality, clinical toxicology, pharmaceuticals, and environmental. I have served on two previous ERPs  (Set 1 and Set 3 for SPDS) and believe I bring the skill set required for the critical evaluation of the  suitability of analytical methods to meet the requirements outlined in the SMPRs.  Sr. Staff Review  Dr. Koerner has been very active in SPDS.  He has been active on SPDS working groups and is a  member of ERPs for SPDS.  He has only applied for the SPDS Vitamin B 12 ERP.  Staff Recommendation  Recommend for the SPDS Vitamin B 12 ERP.  Philip Koerner  Phenomenex  Technology  Industry  USA 

Charles Metcalfe 

Custom Analytics 

CRO 

Industry 

USA 

Statement of Expertise  We are using a UHPLC method to quantitate the lactones and flavokavains  Sr. Staff Review 

Mr. Metcalfe has been very active in SPDS.  While no specifics mentioning kavalactones, he has been  active on SPDS working groups, including the Kavalactones Working Group.  Also, he is a member of 

ERPs for SPDS.  He has only applied for the SPDS Kavalactones ERP.  Staff Recommendation  Recommend for the SPDS Kavalactones ERP. 

Mimi Park 

The Nature’s Bounty  Company 

Supplements 

Industry 

USA 

Statement of Expertise  I currently hold a position as a senior manager of Analytical R&D and Stability for the Nature's Bounty  Co.  We are responsible for evaluating, troubleshooting and improving analytical methods for use in  the QC laboratory for product release.  As a leading dietary supplement company, we have a huge  stake in the AOAC methods.  We run these methods on a daily basis and have vast interest and  knowledge in regard to the performance and challenges with proposed methods.