ERP Proposals for CASP Chemistry Methods

CANNABIS ANALYTICAL SCIENCE PROGRAM  Expert Review Panels for: 

‐ Chemical Contaminants‐ 

PROPOSAL FOR NEW EXPERT REVIEW PANEL  FOR OFFICIAL METHODS BOARD APPROVAL

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I.

PROPOSAL  AOAC has solicited applications for experts to participate on Expert Review Panels for  the Cannabis Analytical Science Program (CASP).  AOAC staff requests that the Official  Methods Board review the included applications for membership to a new Expert  Review Panel focused on Chemical Contaminants in Cannabis and Cannabis Products. II. SUMMARY OF PLANNED ERP ACTIVITIES  The proposed ERP will review methods submitted against an AOAC Call for Methods  . These methods will be reviewed against AOAC SMPR 2019.002, Standard Method  Performance Requirements (SMPRs®) for Identification and Quantitation of Selected  Residual Solvents in Cannabis‐Derived Materials.   As of January 28, 2020, one method  has been submitted for consideration:   Residual Solvents in Cannabis (Suite of Methods for Residual Solvents in Cannabis)   Organization:  Eurofins Food Integrity and Innovation   Submitted by:  Valerie Weiler, Eurofins  Methods are GC‐MS and HS‐GC/MS based.  

III. PROPOSED CASP CHEMICAL CONTAMINANTS ERP ROSTER

First 

Last 

Organization 

ERP Chair  Options  Yes –  OPTION 3  Yes –  OPTION 2 

Recommendation 

Notes to OMB 

Grace  

Bandong 

Eurofins Food Integrity and  Innovation 

Recommend for ERP 

Julia 

Bramante  CDPHE Laboratory Services Division 

Recommend for ERP

Andrew  

Capps 

Capps Consulting LLC 

Yes 

Recommend only if  needed Recommend only if  needed Recommend for ERP

NEEDS OMB  REVIEW  NEEDS OMB  REVIEW 

Nour  Eddine  

ES‐SAFI 

Mohammed V University in Rabat  (Morocco) 

No 

Kate  

Evans 

Longboard Scientific 

Yes  No  Yes  Yes 

Salvatore    Parisi 

Al Balqa Applied University 

Not Sure

NEEDS OMB  REVIEW 

Eric  

Petty  Pham 

Colorado Department of Agriculture 

Recommend for ERP Recommend for ERP Recommend for ERP

Andrew    Melissa  

Alkemist Labs 

Phillips 

NIST 

Yes –  OPTION 1 

Catherine    Rimmer 

NIST 

No 

Recommend for ERP

Richard 

Sams 

KCA Labs 

left blank 

Not at this time

NEEDS OMB  REVIEW 

Marielle  

Weintraub Zilis, LLC 

No  No  No 

Recommend for ERP Recommend for ERP Recommend only if  needed

Walter 

Wilson 

NIST 

SUDHAKAR   Yadlapalli 

FIRST SOURCE LABORATORY  SOLUTIONS LLP 

NEEDS OMB  REVIEW 

IV. PROPOSED 2020 CASP CHEMICAL CONTAMINANTS ERP ROSTER:  PERSPECTIVES

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Broad Perspective

Industry Government

Academia

Specific Perspective

CRO State Government Consulting Research Standards CBD Company

Geography

US ‐ Pacific West US ‐ Plains US ‐ Southeast US ‐ Northeast International

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V.

AOAC CASP CHEMICAL CONTAMINANTS ERP:   MEMBER CVs and STATEMENTS OF EXPERTISE  Book of CVs: https://griegler‐aoac‐org.cld.bz/all‐chem‐cvs/139/#zoom=z BANDONG, GRACE – EUROFINS FOOD INTEGRITY AND INNOVATION  [VIEW CV] I've been in pesticide and contaminant analysis for the last 25 years ‐ as a chemist and as a laboratory  manager. I've worked with industry in reviewing methods/data and approaches for testing for just as  long. In the last 2 to 3 years, I've been active in the Hemp Industry and has served as a resource for  creating contaminant programs and testing of products.  Senior Staff Comments: Expertise in analyzing for contaminant residues and has some work with  hemp – CV states experience. RECOMMEND AS AN ERP MEMBER AND POTENTIAL CHAIR (OPTION #3) BRAMANTE, JULIA – COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT  [VIEW CV] After working in immunology and organic synthesis research, Julia began her career in the  cannabis industry in 2014 at Gobi Labs, one of the first cannabis testing facilities to open in  Colorado. At Gobi, Julia served as supervisory analyst and then laboratory manager, focusing  on method development, validation, and routine analysis on cannabis and cannabis products  for methods including cannabinoid content, residual solvent analysis, Salmonella spp. and STEC  detection, Aspergillus spp. detection, total yeast and mold count, and pesticide residue  analysis. She then transitioned to the Colorado Department of Public Health and Environment’s  Marijuana Reference Laboratory where she currently serves as Lead Scientist, with a focus on  robust method development and validation of cannabis testing methods for best practice and  reference method development. Julia is also the Chair of the Cannabis Chemistry Subdivision of  the American Chemical Society and the Chair of the AOAC CASP Microbiological Contaminants  Working Group.  CAPPS, ANDREW –CAPPS CONSULTING LLC   [VIEW CV]  I am currently working as a consultant primarily in the field of CBD hemp from seed to sale. My interest  in this group stems from assisting two cannabis testing labs seeking ISO 17025 accreditation. Both of  these labs test for cannabinoid content as well as contaminants. Additionally I am currently in the  middle of install and program start‐up for a QC Analytical lab for a large CBD processor in NC. I have  prior experience working on AOAC validations while working at the NC Department of Agriculture: Food  and Drug Division with a Listeria phage tail protein ELFA assay, have familiarity with AFNOR as well as  many levels of validation from FDA pharmaceuticals to sanitary design, and covering Chemistry and  Microbiology analytical approaches. I have experience with mold analysis with a specialized indoor fungi  course at a ASM conference, have lots of PCR and ELISA experience. I also am comfortable using and  interpreting HPLCs, GCs, MALDI‐TOFs, etc.     Lastly, I am interested in this group because of my interest  in FDA related analytical science and see this as a great opportunity to contribute as well as learn.  I apologize for the choppiness of the above but wanted to get everything in on a tight deadline. Senior Staff Comments: Expertise in analyzing contaminants in cannabis – CV states experience RECOMMEND AS AN ERP MEMBER AND POTENTIAL CHAIR (OPTION #2)

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Senior Staff Comments:  Some experience with residual solvent in hemp CBD space Recommend, if needed.

ES‐SAFI, NOUR EDDINE – MOHAMMED V UNIVERSITY IN RABAT [ VIEW CV ]  Chemist with expertise in analytical Chemistry and involved in various AOAc ERPs. 

Senior Staff Comments: Expertise in Analytical Chemistry and Methodology Recommend, if needed 

EVANS, KATE – LONGBOARD SCIENTIFIC  [VIEW CV] Over 20 years analytical testing experience working in both pharmaceutical and clinical regulated  environments, recent cannabis experience included Lab Director position in southern Colorado and  consulting with testing laboratories in Ca. 

Senior Staff Comments:   Some experience although not sure how much Not Sure – OMB, please review and consider

PARISI, SALVATORE – AL BALQA APPLIED UNIVERSITY [ VIEW CV ]  My experience include natural substances such as terpenoids and residuals in other matrices  (for food‐related applications). In the specific ambit of cannabis, I am a member of the  following working groups:   ‐ AOAC SPSFAM Cannabis Working Group  ‐ AOAC CASP Working Group on Microbial Contaminants in Cannabis & Hemp  ‐ AOAC CASP Chemical Contaminants in Cannabis and Hemp Working Group  With reference to AOAC, I am also involved in other AOAC Working Groups and Expert Review  Panels since 2015. I have also obtained the "AOAC ERP of the Year" Award in 2019 with the  ERP for MCPD. Finally, I am a member of the AOAC Official Methods Board at present.  Senior Staff Comments: Has expertise in varied types of analyses for food safety, botanicals and raw  ingredients for nutrients, principle components, and contaminants RECOMMEND AS AN ERP MEMBER PETTY, ERIC – COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT [ VIEW CV ] 30+ years regulatory analytical chemistry experience specific to pesticide residue analysis.  Senior Staff Comments: Has expertise in analysis of contaminants and in hemp and cannabis. CV  states experience. RECOMMEND AS AN ERP MEMBER PHAM, ANDREW – ALKEMIST LABS [ VIEW CV ]  I have worked in the cannabis industry as an analytical chemist in leadership positions since 2012 and  was a regular attendee for the AOAC hemp meetings.  I have developed and validated potency methods  by HPLC for cannabis in flower, extract, and finished goods.  I have developed and validated terpene  methods by GC‐FID.  I have developed and verified pesticide, residual solvent, heavy metal, and  mycotoxin testing for a state regulated testing lab.   I served as chair last year for the American Chemical  Society's Cannabis Chemistry Subdivision.  I have testified as an expert witness in San Diego county for

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over two dozen cases involving cannabis.  I am published in a veterinary nutraceutical textbook from  Springer.  I have personally performed nearly at least 30 USP official methods of analysis for different  botanical products.  Senior Staff Comments: Has experfise in cannabis method development; and analyzing residues in  cannabis and hemp.  CV states exoerience.  RECOMMEND AS AN ERP MEMBER 

PHILLIPS, MELISSA – NIST [ VIEW CV ]  Extensive knowledge of AOAC Official Methods process and method validation.  Developed numerous  methods for active ingredients in dietary supplements and for vitamins in foods.    Senior Staff Comments:   Has e xpertise in evaluating methods for botanicals and cannabis (ERP chair  for Cannabinoids in Cannabis Methods) – CV states experience RECOMMEND AS AN ERP MEMBER AND POTENTIAL CHAIR (OPTION #1)

RIMMER, KATE – NIST [ VIEW CV ]  No statement of expertise provided.   

Senior Staff Comments: Has expertise in evaluating methods for botanicals and dietary  supplements/TDRM – CV states experience RECOMMEND AS AN ERP MEMBER

SAMS, RICHARD– KCA LABS [ VIEW CV ]  I am the Scientific Officer for KCA Labs in Nicholasville, Kentucky. We provide all analytical services for  hemp, consumables, and isolates. Services include LC‐MS analysis for cannabinoids, fungal metabolites,  and pesticides; GC‐MS analysis for terpenes and terpenoids and pesticides, ICP‐MS analysis for heavy  metals, and qPCR analysis for bacteria.  Senior Staff Comments: Has tremendous experience in testing, but CV does not details for relevant  testing.  The statement of expertise seems to describe the organization vs Dr. Sams’ expertise.  NOT AT THIS TIME – OMB PLEASE CONFIRM. WEINTRAUB, MARIELLE – ZILIS, LLC [ VIEW CV ]  I have been working with the hemp industry since 2016. I helped build the testing program at Covance  (now Eurofins) and then left testing to join a vertically integrated hemp company (farming, extraction,  product development). I am a founding board member and the current president of the US Hemp  Authority certification program. I am also on both AHPA and UNPA's hemp/cannabis committees.   Please see attached CV for further details.  Senior Staff Comments:  Has expertise in cannabis and hemp and testing of cannabis and hemp –  CV states expertise.  RECOMMEND AS AN ERP MEMBER

WILSON, WALTER – NIST [ VIEW CV ]  I am leading NIST efforts in developing cannabis reference materials for cannabinoids and contaminants.

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Senior Staff Comments:   Has expertise in developing reference materials for botanicals including  cannabis/hemp using a variety of technologies – CV states expertise. RECOMMEND AS AN ERP MEMBER

YADLAPALLI, SUDHAKAR – FIRST SOURCE LABORATORY SOLUTIONS  [VIEW CV] 

Established First Source laboratory Solutions LLP   (Analytical services) at Hyderabad, India.  First Source is one of the leading CRO in Hyderabad which was inspected by USFDA and also  accredited by NABL for ISO 17025 compliance. First Source support analytical testing  requirements for major Food, Agricultural and Pharmaceuticals industries in accordance to c  GMP requirements.  Expertise in analytical method development, validations  in the  areas FOOD QUALITY ,FOOD  SAFTY  and drug and Pharmaceuticals. Hands on experience on mass spectrometers  ,spectroscopy and chromatographic equipment's.  Senior Staff Comments:   He has expertise in laboratory methodology and evaluating methods. Has  served on AOAC ERPs.  Recommend, if needed

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CANNABIS ANALYTICAL SCIENCE PROGRAM  Expert Review Panels for: 

‐ Cannabinoid Content‐ 

PROPOSAL FOR NEW EXPERT REVIEW PANEL  FOR OFFICIAL METHODS BOARD APPROVAL

1 

I. PROPOSAL  AOAC has solicited applications for experts to participate on Expert Review Panels for  the Cannabis Analytical Science Program (CASP).  AOAC staff requests that the Official  Methods Board review the included applications for possible inclusion on the existing  AOAC Cannabis Expert Review Panel chaired by Melissa Phillips of NIST.   II. SUMMARY OF PLANNED ERP ACTIVITIES  The ERP will review methods submitted against an AOAC Call for Methods . These methods will be reviewed against AOAC SMPR 2019.003, Standard Method  Performance Requirements (SMPRs®) for Identification and Quantitation of Selected  Residual Solvents in Cannabis‐Derived Materials.   As of January 28, 2020, one method  has been submitted for consideration:   CNB‐001: A (U)HPLC‐UV method Development and Validation for Determining  Cannabinoids in Plant Materials of Hemp (low THC Varieties of Cannabis sp.)  o Submitted by Yijn Tang, Applied Food Science  o Technology:  UPHLC‐UV   CNB‐002:   Quantitation of Cannabinoids in Cannabis Dried Plant Materials,  Concentrates and Oils Using Liquid Chromatography‐Diode Array Detection  Technique with Optional Mass Spectrometric Detection o Submitted by Katerina Mastovska, Eurofins Food Integrity & Innovation o Technology:  Liquid Chromatography Diode Array Detection  CNB‐003:  Single‐labotaroty validation of HPLC‐UV identification and  quantification of cannabinoids in low‐THC varieties of Cannabis sativa o Submitted by:  Reginald Rabb o Technology:  HPLV‐UV  CNB‐004:  Determination of Cannabinoids in Hemp by Liquid Chromatography  with UV Absorbance Detection o Submitted by:  Luke Ward, Juniper Analytics o Technology:  LC with UV Detection   CNB‐005:  Quantitative Analysis of Major Cannabinoids in Hemp Fower and Leaf by  LC‐PDA  o Submitted by:  Aihua Liu, Dyad Labs  o Technology:  LC‐PDA 

III.

EXISTING MEMBERS OF THE CANNABINOID CONTENT ERP 

First Name 

Last Name  Audino  Es Safi  Harris  Hudalla  Johnson  Phillips    Phinney  Reibach  Rimmer  Tuzimski  Yadlapalli  Mastovska 

Affiliation 

ERP Status  MEMBER 

Susan 

SA Audino & Associates  Mohammad V University 

Nour Eddine 

MEMBER MEMBER MEMBER MEMBER MEMBER MEMBER MEMBER MEMBER MEMBER MEMBER CHAIR

Heather  

Forensic Chemistry Consultant 

Christopher 

Proverde Labs 

Holly 

AHPA 

Katerina   Melissa  

Eurofins Food Integrity and Innovation 

US NIST 

Curtis  

Curtis Phinney CNS  Smithers Viscient 

Paul   Kate  

US NIST 

Tomasz   Sudhakar 

Medical University of Lublin  First Source Laboratory Solutions 

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The original ERP proposal can be found here: https://cld.bz/DYVN3ye

IV.

NEW APPLICANTS FOR THE CANNABINOID CONTENT ERP First Name  Last Name Affiliation 

Recommendation 

Grace  

Bandong 

Eurofins Food Integrity and Innovation Not at this time 

Julia 

Bramante  CDPHE Laboratory Services Division 

Recommend as Member 

Andrew   Candice  Christian 

Capps 

Capps Consulting LLC 

Not at this time 

Cashman  Krueger 

CEM 

Recommend as Alternate Member  Recommend as Alternate Member  Recommend as Alternate Member  Recommend as Alternate Member 

Complete Phytochemical Solutions 

Aihua 

Liu 

Dyad Laboratories 

Salvatore   

Parisi  Petty  Pham 

Al Balqa Applied University 

Eric  

Colorado Department of Agriculture 

Not at this time 

Andrew   

Alkemist Labs  GAAS Analytical  Caliper Foods 

Recommend as Member   Recommend as Member 

Aniko  Daniel 

Solyom  Watson 

Recommend as Alternate Member 

Marielle  

Weintraub Zilis, LLC 

Recommend as Member 

Walter  Hong 

Wilson 

NIST 

Recommend as Alternate Member  Recommend as Alternate Member 

You 

Eurofins 

V.

PROPOSED ERP   NAME 

AFFILIATION 

ERP POSITION  New Member  New Member  New Member  New Member 

1. 2. 3. 4. 5. 6. 7. 8. 9.

Julia Bramante  Andrew Pham  Aniko Solyom 

CDPHE Laboratory Services Division 

Alkemist Labs  GAAS Analytical 

Marielle Weintraub 

Zilis, LLC 

Susan Audino 

Audino & Associates  Mohammad V University  Forensic Chemistry Consultant 

Member  Member  Member  Member  Member  Member  Member  Member  Member  Member 

Nour Eddine Es‐Safi 

Heather Harris 

Christopher Hudalla 

Proverde Labs 

Holly Johnson 

AHPA 

10. 11. 12. 13. 14. 15. 16.

Katerina Mastovska 

Eurofins Food Integrity and Innovation  Member 

Curtis Phinney  Paul Reibach 

Curtis Phinney CNS  Smithers Viscient 

Catherine Rimmer  Tomasz Tuzimski  Sudhakar Yadlapalli  Melissa Phillips  Candice Cashman  Christian Krueger 

US NIST 

Medical University of Lublin  First Source Laboratory Solutions 

US NIST 

Chair 

CEM 

Alternate Member  Alternate Member  Alternate Member  Alternate Member  Alternate Member  Alternate Member  Alternate Member 

Complete Phytochemical Solutions 

Aihua Liu 

Dyad Laboratories 

Salvatore Parisi  Daniel Watson  Walter Wilson 

Al Balqa Applied University 

Caliper Foods 

US NIST  Eurofins 

Hong You 

VI.

NEW APPLICANT PERSPECTIVES

3 

Broad Perspectives

Industry Government

Academia

Specific Perspectives

CRO

State Government Consulting

Research

Standards

CBD Company

Tech Provider

Geography

US ‐ Pacific West US ‐ Plains

US ‐ Southeast International

US ‐ Northeast

US ‐ Midwest

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VII. AOAC CASP CHEMICAL CONTAMINANTS ERP:  STATEMENTS OF EXPERTISE BANDONG, GRACE – EUROFINS FOOD INTEGRITY AND INNOVATION  [VIEW CV]

I've been in pesticide and contaminant analysis for the last 25 years ‐ as a chemist and as a laboratory  manager. I've worked with industry in reviewing methods/data and approaches for testing for just as  long. In the last 2 to 3 years, I've been active in the Hemp Industry and has served as a resource for  creating contaminant programs and testing of products. 

Senior Staff Comments: Has experience in analyzing hemp for residues and contaminants Not at this time – OMB, please confirm 

BRAMANTE, JULIA – COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT  [VIEW CV] After working in immunology and organic synthesis research, Julia began her career in the  cannabis industry in 2014 at Gobi Labs, one of the first cannabis testing facilities to open in  Colorado. At Gobi, Julia served as supervisory analyst and then laboratory manager, focusing  on method development, validation, and routine analysis on cannabis and cannabis products  for methods including cannabinoid content, residual solvent analysis, Salmonella spp. and STEC  detection, Aspergillus spp. detection, total yeast and mold count, and pesticide residue  analysis. She then transitioned to the Colorado Department of Public Health and Environment’s  Marijuana Reference Laboratory where she currently serves as Lead Scientist, with a focus on  robust method development and validation of cannabis testing methods for best practice and  reference method development. Julia is also the Chair of the Cannabis Chemistry Subdivision of  the American Chemical Society and the Chair of the AOAC CASP Microbiological Contaminants  Working Group.  CAPPS, ANDREW –CAPPS CONSULTING LLC   [VIEW CV]  I am currently working as a consultant primarily in the field of CBD hemp from seed to sale. My interest  in this group stems from assisting two cannabis testing labs seeking ISO 17025 accreditation. Both of  these labs test for cannabinoid content as well as contaminants. Additionally I am currently in the  middle of install and program start‐up for a QC Analytical lab for a large CBD processor in NC. I have  prior experience working on AOAC validations while working at the NC Department of Agriculture: Food  and Drug Division with a Listeria phage tail protein ELFA assay, have familiarity with AFNOR as well as  many levels of validation from FDA pharmaceuticals to sanitary design, and covering Chemistry and  Microbiology analytical approaches. I have experience with mold analysis with a specialized indoor fungi  course at a ASM conference, have lots of PCR and ELISA experience. I also am comfortable using and  interpreting HPLCs, GCs, MALDI‐TOFs, etc.     Lastly, I am interested in this group because of my interest  in FDA related analytical science and see this as a great opportunity to contribute as well as learn.  I apologize for the choppiness of the above but wanted to get everything in on a tight deadline.  Senior Staff Comments: Has experience with analyzing cannabinoids in hemp/cannabis RECOMMEND AS AN ERP MEMBER 

Senior Staff Comments: No direct expertise seen.

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NOT AT THIS TIME – OMB TO CONFIRM

CASHMAN, CANDICE – CEM CORPORATION [ VIEW CV ]  I have spent the past 2.5 years submerged in the sample prep industry, with an extensive focus  on cannabinoids. I have focused on both using consumables and automated extraction  machinery to isolate cannabinoids from a variety of matrices, including plant material. I have  developed successful sample prep methods for the measurement of cannabinoids. I also have  experience extracting plant material in general.  Senior Staff Comments: Has experience with sample prep and analysis of cannabis with cannabinoids  RECOMMEND AS AN ALTERNATE ERP MEMBER   KRUEGER, CHRISTIAN – COMPLETE PHYTOCHEMICAL SOLUTIONS [ VIEW CV ]  My interest is in serving on the ERP for Quantitation of Cannabinoids in Plant Materials of Hemp (Low  THC Varieties of Cannabis sp). I am currently involved with the development of analytic methods to  quantify cannabinoids of Hemp in both the public (University of Wisconsin‐Madison) and private  (Complete Phytochemical Solutions, LLC) sectors. I have over 25 years of expertise in separation  chemistry and method development (HPLC, LC/MS, MALDI‐TOF MS, colorimertric) for identification and  quantification of individual monomeric phytochemicals (i.e. cannabanoids and anthocyanins) and  oligomeric polyphenols (proanthocyanidins and hydrolyzable tannins).  Senior Staff Comments: Has expertise in analyzing botanicals and ingredients for extracts,  concentrates, and phytochemicals.  RECOMMEND AS AN ALTERNATE ERP MEMBER  LIU, AIHUA – DYAD LABORATORIES [CV IN BOOK]  I have more than 15 years experience on analytical method development/validation/sample  analysis under GLP and cGMP regulations with using most advanced analytical instruments like  UPLC/HPLC, MS/MS, MSn, PDA, QE‐HR‐MS, FLD, GC/MS/MS and GC‐FID instruments. I also  have established more than 10 years experience on lab management. I enjoy and keep on  publishing papers in international scientific conferences and peer‐reviewed journals.  Senior Staff Comments: Has expertise in analytical method development and validation across a  broad range of instrument platforms  RECOMMEND AS AN ALTERNATE ERP MEMBER  PARISI, SALVATORE – AL BALQA APPLIED UNIVERSITY [ VIEW CV ]  My experience include natural substances such as terpenoids and residuals in other matrices  (for food‐related applications). In the specific ambit of cannabis, I am a member of the  following working groups:   ‐ AOAC SPSFAM Cannabis Working Group  ‐ AOAC CASP Working Group on Microbial Contaminants in Cannabis & Hemp  ‐ AOAC CASP Chemical Contaminants in Cannabis and Hemp Working Group

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With reference to AOAC, I am also involved in other AOAC Working Groups and Expert Review  Panels since 2015. I have also obtained the "AOAC ERP of the Year" Award in 2019 with the  ERP for MCPD. Finally, I am a member of the AOAC Official Methods Board at present.  Senior Staff Comments:   Has expertise in varied types of analyses for food safety, botanicals and raw  ingredients for nutrients, principle components, and contaminants RECOMMEND AS AN ALTERNATE ERP MEMBER

PETTY, ERIC – COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT [ VIEW CV ] 30+ years regulatory analytical chemistry experience specific to pesticide residue analysis. 

Senior Staff Comments:   Has expertise in pesticide residue analysis.  NOT AT THIS TIME – OMB, PLEASE CONFIRM. 

PHAM, ANDREW – ALKEMIST LABS [ VIEW CV ]  I have worked in the cannabis industry as an analytical chemist in leadership positions since 2012, and  was a regular attendee for the AOAC hemp meetings.  I have developed and validated potency methods  by HPLC for cannabis in flower, extract, and finished goods.  I have developed and validated terpene  methods by GC‐FID.  I have developed and verified pesticide, residual solvent, heavy metal, and  mycotoxin testing for a state regulated testing lab.   I served as chair last year for the American Chemical  Society's Cannabis Chemistry Subdivision.  I have testified as an expert witness in San Diego county for  over two dozen cases involving cannabis.  I am published in a veterinary nutraceutical textbook from  Springer.  I have personally performed nearly at least 30 USP official methods of analysis for different  botanical products.  Senior Staff Comments:   Has expertise in cannabis testing and cannabis methods for flower and  extracts  RECOMMEND AS AN ERP MEMBER  SOLYOM, ANIKO – GAAS Analytical [ VIEW CV ]  I have more than 30 years of comprehensive experience in analytical method development and  validation, using a wide variety of analytical techniques. My expertise is in the development and  validation of analytical methods with a particular emphasis on HPLC, LC‐MS applications and bioactivity  guided preparative separation of complex mixtures and analysis of biological samples and dietary  supplements. In addition to HPLC technique I have significant experience with atomic absorption  spectroscopy (AA), inductively coupled plasma emission spectroscopy (ICP), photoacoustic spectroscopy  (PA), UV‐Vis spectroscopy, elemental analysis, mass spectrometry (MS), gas chromatography (GC), GC‐ MS, LC‐MS, NMR and wet techniques.  Before founding GAAS Analytical, I served as director of the  Analytical Core at an NIH funded Botanical Center (Arizona Center for Phytomedicine Research). The  Facility focused on quantitation and identification of natural products and dietary supplements,  particularly anti‐inflammatory compounds derived from turmeric, ginger and boswellia. I developed  methods to analyze these compounds in plant materials, extracts, commercially available dietary  supplements and in different biological matrices. I also developed and validated new assay methods  according to cGLP regulations, to quantify novel cancer drugs in plasma and urine using QQQ LC/MS  technique; identifying metabolites of new cancer drugs in plasma and urine using TOF LC/MS technique  and calculating pharmacokinetic parameters.  I am an active member of AOAC International; I joined the  organization in 2002. For years I’ve been serving as member of AOAC’s Stakeholder Panel on Dietary  Supplements and the Presidential Task Force on Dietary Supplements of AOAC. I was one of the AOAC  Horwitz advisors until the restructuring of the Official Methods of Analysis (OMA) process in January

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2008, when the role of method advisors and Horwitz advisors was retired. Currently I am member of the  Dietary Supplement Subcommittee of ALACC and a liaison on the AOAC Technical Programming  Committee. In 2019 I was selected as one of the nine voting members of the inaugural Analytical  Solutions Forum Steering Committee.   Since I joined AOAC, I participated in the preparation of multiple  SMPR‐s as a member of various working groups, including Aloe Vera, Anthocyanins, Ashwagandha,  Cannabis, Cannabinoids in Consumables. Chondroitin, Cinnamon, Folin‐C, Free Amino Acids, Ginger,  Lutein, Kratom, Protein, Turmeric (as chair of the group) and Vitamins B12, K1 and K2. Most recently I  was member of the “Cannabinoids in Consumables” working group and currently I am a member of the  “CASP Cannabinoids” working group.  During the last 10 years I served on the panel of multiple ERP‐s,  including Aloin, Anthocyanins, Ashwagandha, Chrondoitin, Ginger, Folin‐C, Lutein, SAMe, Tea, Turmeric,  Yohimbe and Vitamin B12.  In addition to my volunteer work at AOAC, I also volunteer at USP.  I was  selected in 2015 to serve a 5‐year term as a member of USP’s Non‐botanical Dietary Supplements Expert  Committee.  Senior Staff Comments:    Has expertise in botanicals and dietary supplements and analysis thereof.  RECOMMEND AS AN ERP MEMBER  WATSON, DANIEL – CALIPER FOODS [ VIEW CV ]  I've worked at a MED testing lab testing potency of cannabinoids in flower, concentrates and infused  products. I am currently employed with Caliper Foods as their Process Chemist running our R&D potency  testing and other tests as they become available. I am responsible for method development and method  validation for our internal methodology and review of external methodology.  Senior Staff Comments:   Has experience with hemp and cannabis testing, method development and  analysis of cannabinoids.  RECOMMEND AS AN ALTERNATE ERP MEMBER 

WEINTRAUB, MARIELLE – ZILIS, LLC [ VIEW CV ]  I have been working with the hemp industry since 2016. I helped build the testing program at Covance  (now Eurofins) and then left testing to join a vertically integrated hemp company (farming, extraction,  product development). I am a founding board member and the current president of the US Hemp  Authority certification program. I am also on both AHPA and UNPA's hemp/cannabis committees.   Please see attached CV for further details. 

Senior Staff Comments:   Has expertise in hemp and analysis of hemp. RECOMMEND AS AN ERP MEMBER 

WILSON, WALTER – NIST [ VIEW CV ]  I am leading NIST efforts in developing cannabis reference materials for cannabinoids and contaminants.  Senior Staff Comments:   Has expertise in developing reference materials for botanicals including  cannabis/hemp using a variety of technologies – CV states expertise. RECOMMEND AS AN ALTERNATE ERP MEMBER  YOU, HONG – EUROFINS [ VIEW CV ]  I am currently the Director of R&D at Eurofins Dietary Supplement Analysis Center. With a  Ph.D. degree in Nutrition Sciences and a Masters degree in Food Science, I have more than 10

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years experience in analytical method development and validation for food and dietary  supplements, which include, but are not limited to carotenoids, xanthrophylls, isothiocyanates,  flavonoids, amino acids and vitamins. I am familiar with multiple analytical techniques  including HPLC‐DAD, HPLC‐MS/MS, HPLC‐ELSD, HPLC‐FLD, GC‐FID, GC‐MS, CE‐DAD, HPTLC, and  UV/VIS/FL spectrophotometers. Moreover, I was the Primary/Secondary reviewers of 10 AOAC  Expert Review Panels for evaluating food and dietary supplements Official Methods of Analysis  (OMA). I have also reviewed 46 journal manuscripts for Food Chemistry, Food Research  International, J of AOAC Int, J Food Biochemistry, and 61 conference abstracts for Experimental  Biology Annual Conferences. I have published 24 peer‐reviewed papers as corresponding  author, first author, or coauthor. I am the method developer of AOAC OMA first action  2018.04.  Eurofins has over 1000 validated analytical methods and conducts routine analysis for food,  dietary supplements, pharmaceuticals, and botanicals on a daily bases. AOAC plays a crucial  role in the food/dietary supplement industry.  As a Eurofins representative and a working  group member for drafting the Cannabis Potency SMPR, I look forward to the opportunity to  serve as an ERP member for reviewing the new cannabionoid method. 

Senior Staff Comments:   Has expertise in developing and evaluating botanical methods with various  instrument platforms; has familiarity as an ERP member  RECOMMEND AS AN ALTERNATE ERP MEMBER

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Grace Bandong Address 10 N. Livingston St., Madison, WI 53703 Phone 925 519 4953 E-mail gracebandong@gmail.com

Director with over 25 years experience in developing, managing and implementing supplier monitoring programs in the food and dietary supplement industry with a focus on contaminants. Extensive experience in assisting companies and their suppliers including growers and ingredient providers with interpreting regulations and providing solutions that comply with regulations. An expert, with more than 25 years experience, in contaminant testing particularly pesticides and heavy metals. Experience 03-2016 - present Associate Director, Global Scientific Strategy Leader, Contaminants Eurofins FII (formerly Covance Food Solutions) Responsibilities:

Achievements: Develop residue testing programs • Assist companies in interpreting regulations and create solutions to meet regulations • Maintain industry relations through presentations and active membership/leadership roles in scientific organizations • Subject matter expert for contaminants and work with commercial (sales) team in delivering relevant, practical and sustainable programs for clients. • Provide chemical risk assessments to clients and develop supplier programs. • Developed a contaminant testing program, including developing a pesticide residue list, for the hemp industry that's been utilized by many of the leading hemp retailers/distributors and lead to successful monitoring programs to ensure quality for consumers. The program has brought in an increase in revenue of greater than $1.5M to date. • Trained senior laboratory staff in practical approaches to pesticide residue testing that lead to an increase in meeting turn around times from 60% to 94% and a savings in operational cost of about 10%. • Mentored technical leaders in developing a 480+ compound screen for hemp. Method was accepted as a poster presentation at the European Pesticide Residue Workshop in 2018 and is currently available to the hemp industry. • Completed chemical risk assessments for several clients that brought in supplier programs that generate revenue of about $500,000 annually. •

Division Manager, Contaminants The National Food Laboratory Responsibilities

01-2008 - 02-2016

Manage operations of Contaminant division (largely pesticides and heavy metals) • Meet revenue targets for Division •

Achievements

My team grew the contaminant division from a $1.5M business in 2008 to almost $6M in 2016 • Under my leadership, The NFL was recognized as the "gold standard" for pesticide residue testing by industry • Developed Chemical Risk Assessment process that is currently used by Fortune 500 food companies as a basis for thei supplier verification systems. • Achieved ISO 17025 accreditation for the laboratory. •

Project Manager, Pesticides The National Food Laboratory Responsibilities

07-1998 - 12-2007

Manage pesticide testing laboratory • Develop analytical programs for residue testing • Train staff in pesticide residue analysis •

Achievements

Developed pesticide lists that is used by the food industry for pesticide monitoring •

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Developed a training laboratory for residue analysis • Adapted QuECheRS, then a novel approach and became the standard in 2007, in the laboratory •

Chemist The National Food Laboratory Responsibilities:

07-1994 - 12-1997

Analyzed pesticides using Luke Method and GC -FPD/NPD/ECD • Analyzed pesticdes using HPLC and post column derivatization with fluorescence detection • Maintain instruments in the laboratory •

Achievement:

Developed process that allowed the laboratory to increase production from 8 samples to 25 samples a day •

Chemist Del Monte Foods Operate HPLC for Carbamates analysis Extract samples for pesticide residue analysis

01-1991 - 05-1994

Education

University of Houston, Houston, TX M.S. in Chemistry, 1988 University of the Philippines, Diliman, Quezon City, Philippines B.S. Chemistry 1986

Organizations/Conferences 01-2000 - present

AOAC International Currently on the Executive Board of the PSW AOAC section

FIACC (Food Industry Analytical Chemist Committee) Chairperson for committee - 2014 to 2016 Responsible for Pesticide residue round robin testing - preparing samples for testing

01-1997 - 12-2017

European Pesticide Residue Workshop Participant

05-2000 - present

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Julia Bramante 5280 W. 17 th Ave, #113, Lakewood, CO 80214

216-659-3899

jmbramante@gmail.com

PROFESSIONAL/RESEARCH EXPERIENCE

Marijuana Reference Laboratory, Colorado Department of Public Health and Environment Laboratory Services Division; Denver, CO (September 2017-present) Laboratory Lead Scientist (March 2019-present) Quality Assurance Officer (September 2017-February 2019)  The Marijuana Reference Laboratory exists to provide a technical resource for private cannabis testing facilities and cannabis product manufacturers. Acting as the source for analytical method development for cannabis potency, pesticide residues, heavy metals, residual solvents and microbiological contaminant analyses, the laboratory provides technical laboratory information and training to the private laboratory industry, as well as testing methodologies to increase the effectiveness of the state cannabis testing reference library.  Plans, implements, and directs method development and method validation activities and experimentation for cannabis potency, pesticide residues, heavy metals, residual solvents and microbiological contaminant analyses utilizing, but not limited to, LC-MS QTOF, GC-FID, GC-MS, ICP-MS, qPCR, MALDI-TOF, and cultural methodology.  Applies knowledge of quality assurance, accreditation requirements, scientific principles, and analytical skills to continually develop and improve quality and efficiency of the laboratory.  Plans, implements, and directs QA/QC activities to ensure lab testing provides the highest quality analytical results while ensuring compliance with laboratory protocols and accreditation requirements, including ISO 17025. Gobi Analytical is a state certified cannabis testing laboratory that focuses on the analysis and research of cannabis and cannabis related products through regulatory testing and method development.  Responsible for the overall operation, leadership, and administration of the testing facility in accordance with state regulations governing retail and medical cannabis testing facilities.  Directly assisted the Laboratory Director to conduct new method development and implementation, validations, laboratory certifications, and standard operating procedure writing, tracking, updating, and review.  High Performance Liquid Chromatography (HPLC), Gas Chromatography-Flame Ionization Detection (GC-FID), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Tandem Mass Spectrometry (LC-MSMS), qPCR, and cultural methodology were used to analyze an array of cannabis matrices for cannabinoid potency, terpene content, residual solvents, pesticide residues, and microbiological contaminants. Gobi Analytical; Wheat Ridge, CO (August 2014-September 2017) Laboratory Manager (January 2017-September 2017) Supervisory Analyst (August 2015-December 2016) Chemistry and Microbiology Laboratory Analyst (August 2014-August 2015) 

Sales and Marketing Lead (November 2015-December 2016) 

Developed the website copy for Gobi’s new website, implemented in June of 2016.  Responsible for weekly status meetings and direct communication with the company’s advertising agency to develop all marketing and sales materials such as print-ads, brochures, direct mail posters, and social media content.

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Julia Bramante 5280 W. 17 th Ave, #113, Lakewood, CO 80214

216-659-3899

jmbramante@gmail.com

Research Assistant, Divisions of Infectious Diseases and Clinical Immunology, Anschutz Medical Campus; Aurora, CO (Summer 2011 and 2012)  Identified the blood Natural Killer (NK) cell responses to commensal bacteria in HIV-1 infection compared to healthy donors. Investigated Dendritic cell responses and specific markers on these cell subsets in chronic HIV-1 infected individuals and HIV-1 suppressed individuals.  Performed flow cytometry, ELISA assays, cell culture, blood processing, blood draws, immunohistology fluorescent imaging, and data analysis. Undergraduate Research Assistant, Department of Chemistry and Biochemistry, University of Denver; Denver, CO (January 2013-June 2014)  Synthesized hydroxyquinoline carboxylic acid analogs for application to new tuberculosis vaccination and antibiotics.  Performed organic synthesis, proton nuclear magnetic resonance ( 1 H-NMR) spectroscopy operation and data analysis, liquid chromatography-mass spectrometry (LC-MS) operation and analysis, and general chemistry laboratory techniques. Undergraduate Research Assistant, Department of Biological Sciences, University of Denver; Denver, CO (September 2010- September 2012)  Performed cell tissue culture, microscopic imaging, and electron microscope operation and imaging to successfully capture and develop film of microtubule movement and chromosome transformation in mammalian cells during cell division and replication. Student Research Assistant, Department of Infectious Diseases, Case Western Reserve University; Cleveland, OH (Summer 2009 and 2010)  Studied autoimmune disease effects on immune responses from CD56 NK cell subsets in healthy donor blood, as well as rheumatoid factor infected blood.  Performed blood processing (the peripheral blood mononuclear cell isolation and staining) and blood draw, ELISPOT assay analysis, ELISA assay analysis, and isolation of CD56 positive cells by Miltenyi CD56 microbead isolation kit. Assistant to the Coordinator, American Indian Services Coordination, Center for Multicultural Excellence, University of Denver; Denver, CO (September 2012-June 2014)  Worked with the American Indian Services Coordinator to organize university sponsored events relating to American Indian culture and education.  Oversaw and promoted American Indian events at DU and in the greater Denver area.  Led the planning and promotion of the Russell Means Legacy Art Exhibition, an event commemorating Russell Means’ life.

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Julia Bramante 5280 W. 17 th Ave, #113, Lakewood, CO 80214

216-659-3899

jmbramante@gmail.com

ADDITIONAL LEADERSHIP/VOLUNTEER EXPERIENCE Cannabis Chemistry Subdivision of the American Chemical Society  Chair (January 2019-present)  Secretary (March 2018-December 2018)  Membership and Social Chair (September 2017-March 2018)  Events Chair (November 2016-September 2017)

AOAC Cannabis Analytical Science Program (CASP) Microbial Contaminants Working Group  Chair (April 2019-present)

Chemical Contaminants in Cannabis and Hemp Working Group  Contributing Member (April 2019-present)

Cannabinoids in Consumables Working Group 

Contributing Member (April 2019-present)

Colorado Marijuana Science and Policy Work Group  Contributing Member (2018-present)

Colorado Pesticide Method Detection Limit Work Group  Contributing Member (2016-2017)

Colorado Sampling Protocol Work Group  Contributing Member Group (2016-2017)

Colorado Laboratory Council 

Contributing Member (2015-2017)

Native Student Alliance 

Co-President (August 2012-June 2014)

Black Mesa Colorado Caravan 

Contributing Member (September 2012-September 2016)

PUBLICATIONS Dillon SM, Lee EJ, Bramante JM, Barker E, Wilson CC. The Natural Killer Cell Interferon-gamma Response to Bacteria is Diminished in Untreated HIV-1 Infection and Defects Persist Despite Viral Suppression. Journal of Acquired Immune Deficiency Syndromes (1999) . 2014;65(3):259-267.

Page 3 of 4

Julia Bramante 5280 W. 17 th Ave, #113, Lakewood, CO 80214

216-659-3899

jmbramante@gmail.com

EDUCATION University of Denver; Denver, CO B.S. Chemistry, ACS (American Chemical Society Accredited); Minors: Chinese, Biology, Mathematics (2010-2014)

East China Normal University; Shanghai, China (Summer 2009) Participated in a three month immersion program in China to study Chinese language and culture.

AWARDS 

Distinguished Senior Student 2014, University of Denver  Pioneer Award 2014 Nominee, University of Denver

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ANDREW CAPPS 953 NC HWY 9• Black Mountain, NC 28711 919.606.8746 • info@capps-consulting.com _______________________________________________________________________________________________________________________

EDUCATION

NORTH CAROLINA STATE UNIVERSITY B.S.: Microbiology  Minors: Biotechnology, Genetics 

RELEVANT EXPERIENCE  www.linkedin.com/in/andrew-capps 04/19 - Present  PRINCIPAL/ CONSULTANT Capps Consulting LLC

◊ ​ consultant, auditor, writer, and trainer in FDA regulated industries: ​ ​ Food, Beverage, Natural products  (including Dietary Supplements and Hemp CBD), Pharmaceuticals, laboratories and quality systems expertise.  ◊ ​ Work primarily in hemp CBD space with cGMP compliance, education, and analytical testing consulting. Currently  setting up a cannabinoid content, residual solvent, terpene, mycotoxin, pesticide, and microbial contaminant in-house  QC laboratory for CBD processor.  ◊ ​ Additionally work with two cannabis testing laboratories in pre-audit ISO 17025 consulting and policy/ procedure  writing.  09/14 – 04/19  TEST KITCHEN COORDINATOR / INDUSTRY TRAINER BioNetwork (North Carolina Community College System) ◊ ​ Developed courses and training programs in product safety, defense, regulatory compliance, documentation, auditing,   and advanced laboratory methodology ◊ ​ Conducted on-site and off-site training for food, natural product, biomanufacturing, and pharmaceutical industries   (worked with over 65 companies) ◊ Subject matter expert in food, regulatory compliance, microbiology, and molecular biology  ◊ Oversaw operations of ​ rentable test kitchen laboratory, including ​ equipment acquisitions and ​ client consultation ◊ ​ Represented BioNetwork at external meetings, conferences and in committees; promoted resources, capabilities and   programs to internal and external customers ◊ Served on internal laboratory coordinator working group  ◊ ​ Assisted in identifying subject matter experts, adjuncts, and other resources associated with FDA regulated industries ◊ ​ Maintained currency in field of expertise, in training and instructional development, and in course delivery to ensure   best practices  ◊ A-B Tech Community College Staff Association Vice President: FY 2017-18   11/12 – 09/14  CHIEF MICROBIOLOGIST North Carolina Department of Agriculture, Food and Drug Protection Division  ◊ Managed microbiology laboratory unit, including food and dairy, meat and poultry, disinfectant, QC, and media   preparation microbiology sections   ◊ Principal Investigator for FDA FERN, FDA BSE, USDA FSIS FERN, and CDC/APHL   Cooperative agreement projects  ◊ Oversaw hospital sterilant and disinfectant antimicrobial efficacy testing per EPA GLP (40 CFR Part 160) requirements  ◊ Assured conformance to ISO/IEC 17025:2005 policies and procedures in the laboratory to maintain accreditation   ◊ ISO/IEC 17025:2005 and Quality Management System (QMS) mentor to State ISO CAP and FERN laboratories  ◊ Member of Quality Management Board  ◊ Conducted customer meetings to discuss microbial limits in food, methodology, testing needs,   and timelines 

◊ Collaborated with local, state, and federal partner agencies to provide surge testing capacity   ◊ Led laboratory activities during food outbreak and emergency situations, including targeted 

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Andrew Capps CV

inspection visits   ◊ Researched and implemented new technologies for pathogen and QI organism detection   ◊ Oversaw laboratory operating budget and equipment acquisitions   ◊ Evaluated the performance of employees through performance metrics, appraisals and development  plans  ◊ Facilitated participation in training opportunities to ensure technical competence of laboratory staff   ◊ Oversaw laboratory section biosafety, risk/hazard assessments, biohazardous waste sterilization   ◊ Shipped laboratory’s infectious substances for PFGE analysis and partner agency sharing 

09/12 – 11/12  AGRICULTURAL ​ ​ MICROBIOLOGY SUPERVISOR North Carolina Department of Agriculture, Food and Drug Protection Division

◊ Managed food and dairy and meat & poultry microbiology sections consisting of 8 direct reports  ◊ Maintained administrative and cooperative agreement duties of vacant Chief Microbiologist position  ◊ Conducted customer meetings to discuss methodology, testing needs, and timelines  ◊ Principal Investigator for FDA FERN and FSIS FERN Cooperative agreement projects  ◊ Assured conformance to ISO/IEC 17025:2005 policies and procedures in the laboratory to maintain   accreditation   ◊ Collaborated with local, state, and federal partner agencies to provide surge capacity   ◊ Oversaw laboratory operating budget and equipment acquisitions   ◊ Facilitated participation in training opportunities, vendor training, and ensured competency of   laboratory staff   04/10 – 09/12 QA MICROBIOLOGY SPECIALIST North Carolina Department of Agriculture: Food and Drug Protection Division  ◊ Maintained QMS per ISO/IEC 17025:2005 ALACC requirements  ◊ Ensured compliance with EPA GLP (40 CFR Part 160) requirements in disinfectant testing  ◊ Attended annual meetings of professional organizations (AOAC, ASM, IAFP)  ◊ Auditor for Microbiology and Chemistry Labs  ◊ Trained laboratory staff on QMS and technical procedures  ◊ Assisted staff in determining measurement traceability, statistical process controls, and validation plans  ◊ Assisted with and directed database development to support QMS  ◊ Created GLP Auditing procedure for EPA antimicrobial efficacy testing  ◊ Developed a tablet PC based audit procedure ​ / ​ process that enabled paperless auditing  08/08 – 02/10 TEACHING ASSISTANT Department of Biology and Marine Biology, ​ ​ University of ​ ​ North Carolina: Wilmington  ◊ Instructor of laboratory course “BIO 425: Microbiology with a Biomedical Emphasis”  ◊ Served as Microbiology technical expert for laboratory ​ / ​ QMS  ◊ Reviewed and gave final approval on Microbiology SOPs  ◊ Reviewed/co-authored/ authored QMS SOPs  ◊ Created all course materials (PowerPoints, virtual labs) from scratch  ◊ Supervised/Instructed 2 teaching assistants in how to conduct the course   ◊ Supervised 6 work-study students in media preparation and culturing techniques  ◊ Maintained stock cultures of clinically relevant microorganisms  08/08 - 02/10  GRADUATE RESEARCHER Department of Biology and Marine Biology, University of North Carolina: ​ Research Mentor: Dr. Ann Stapleton  ◊ Examined Quantitative Trait Loci (Association Mapping) of maize plants   ◊ Grew 7,000 plants from seed, overlooking controlled growth and day to day maintenance  ◊ Measured multiple plant traits, took pictures, used NextEngine 3D Scanner on select plants  ◊ Supervised Undergraduate in aforementioned duties  ◊ Analyzed data using statistical software program R and mapping software QTLNetwork  ​ Wilmington 

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Andrew Capps CV