Search Results - "Weitzel, Jane"

Improving and Comparing Probiotic Plate Count Methods by Analytical Procedure Lifecycle Management by Weitzel, M. L. Jane, Vegge, Christina S., Pane, Marco, Goldman, Virginia S., Koshy, Binu, Porsby, Cisse Hedegaard, Burguière, Pierre, Schoeni, Jean L.

“…Probiotics are live microorganisms that confer a health benefit to the host when administered in adequate amounts. This definition links probiotic efficacy to…”
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Ongoing Analytical Procedure Performance Verification Using a Risk-Based Approach to Determine Performance Monitoring Requirements by Borman, Phil J., Guiraldelli, Amanda M., Weitzel, Jane, Thompson, Sarah, Ermer, Joachim, Roussel, Jean-Marc, Marach, Jaime, Sproule, Stephanie, Pappa, Horacio N.

“…The analytical procedure life cycle (APLC) provides a holistic framework to ensure analytical procedure fitness for purpose. USP’s general chapter considers…”
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Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group by Weitzel, Jane, Pappa, Horacio, Banik, Gregory M., Barker, Amy R., Bladen, Elizabeth, Chirmule, Narendra, DeFeo, Joseph, Devine, Jennifer, Emrick, Steven, Hout, Taha Kass, Levy, Michael S., Mahlangu, Gugu N., Rellahan, Barbara, Venema, Jaap, Workman, Wesley

“…Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the…”
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TDRM workshop on reference materials at the AOAC annual meeting 2015: How do I set up proper inter-laboratory comparison with testing materials I have prepared myself? by Budin, John, Emteborg, Håkan, Fox, Arlene, Andrews, Karen, Weitzel, Jane, Rettinger, Mitzi, Zink, Donna

“…The aspect about inherent variation in the testing material and the effects of transport (i.e., high temperatures) are sometimes neglected to the detriment of…”
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TDLM/TDRM workshop on reference materials at the AOAC annual meeting 2012: enabling accuracy/trueness control in analytical method validation and verification by Emteborg, Håkan, Weitzel, Jane, Budin, John, Rettinger, Mitzi, Fox, Arlene

“…[...]the climate orbiter was placed too low for orbital insertion in the Martian atmosphere and thereafter crashed or reentered into space. Proficiency testing…”
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AOAC SMPR® 2017.001. Standard Method Performance Requirements (SMPRs) for Quantitation of Cannabinoids in Cannabis Concentrates by Audino, Susan, Angerhofer, Mark, Atkins, Patricia, Brauninger, Roger M, Brown, Paula N, Burdette, Carolyn Quarles, Clifford, Robert, Cook, Jo Marie, Donelson, Jennifer, George, Kevin, Gibson, Peter, Harris, Heather L, Hartlein, Thomas, Hodgin, George, Inerowicz, Dorota, Johnson, Holly E, Joseph, George, Konings, Erik J M, Kowalski, Julie A, Krogull, Mary Kay, Kuzdzal, Scott, Lockerman, Robert, Ludwig, Cynthia, Marrongelli, Christina, Mastovska, Katerina, Mudge, Elizabeth, Niehaus, Gary D, Nishimura, Masayuki, Phillips, Melissa Meaney, Phinney, Curtis S, Reif, Klaus, Rigdon, Amanda, Rimmer, Catherine A, Ruthenburg, Travis, Solyom, Aniko M, Stenerson, Katherine, Sudberg, Sidney, Sutton, Alan, Szpylka, John, Weitzel, Jane, Winkler, Paul, Wong, Seth, Wurzer, Joshua, You, Hong, Coates, Scott G

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AOAC SMPR® 2017.002:Standard Method Performance Requirements (SMPRs) for Quantitation of Cannabinoids in Dried Plant Materials by Audino, Susan, Angerhofer, Mark, Atkins, Patricia, Brauninger, Roger M, Brown, Paula N, Burdette, Carolyn Quarles, Clifford, Robert, Cook, Jo Marie, Donelson, Jennifer, George, Kevin, Gibson, Peter, Harris, Heather L, Hartlein, Thomas, Hodgin, George, Inerowicz, Dorota, Johnson, Holly E, Joseph, George, Konings, Erik J M, Kowalski, Julie A, Krogull, Mary Kay, Kuzdzal, Scott, Lockerman, Robert, Ludwig, Cynthia, Marrongelli, Christina, Mastovska, Katerina, Mudge, Elizabeth, Niehaus, Gary D, Nishimura, Masayuki, Phillips, Melissa Meaney, Phinney, Curtis S, Reif, Klaus, Rigdon, Amanda, Rimmer, Catherine A, Ruthenburg, Travis, Solyom, Aniko M, Stenerson, Katherine, Sudberg, Sidney, Sutton, Alan, Szpylka, John, Weitzel, Jane, Winkler, Paul, Wong, Seth, Wurzer, Joshua, You, Hong, Coates, Scott G

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AOAC SMPR® 2017.002 by Audino, Susan, Angerhofer, Mark, Atkins, Patricia, Brauninger, Roger M, Brown, Paula N, Burdette, Carolyn Quarles, Clifford, Robert, Cook, Jo Marie, Donelson, Jennifer, George, Kevin, Gibson, Peter, Harris, Heather L, Hartlein, Thomas, Hodgin, George, Inerowicz, Dorota, Johnson, Holly E, Joseph, George, Konings, Erik J M, Kowalski, Julie A, Krogull, Mary Kay, Kuzdzal, Scott, Lockerman, Robert, Ludwig, Cynthia, Marrongelli, Christina, Mastovska, Katerina, Mudge, Elizabeth, Niehaus, Gary D, Nishimura, Masayuki, Phillips, Melissa Meaney, Phinney, Curtis S, Reif, Klaus, Rigdon, Amanda, Rimmer, Catherine A, Ruthenburg, Travis, Solyom, Aniko M, Stenerson, Katherine, Sudberg, Sidney, Sutton, Alan, Szpylka, John, Weitzel, Jane, Winkler, Paul, Wong, Seth, Wurzer, Joshua, You, Hong, Coates, Scott G

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TDRM/TDLM Workshop at the AOAC INTERNATIONAL Annual Meeting 2013 by Emons, Hendrik, Weitzel, Jane, Budin, John, Cappozzo, Jack, Jaudzem, Greg, Quilliam, Michael, Rettinger, Mitzi, Sen, Sumit, Tholen, Dan, Zink, Donna

“…The Technical Divisions on Reference Materials (TDRM) and Laboratory Management (TDLM) offered the workshop “Building the use of certified reference materials…”
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TDRM/TDLM workshop on reference materials and laboratory accreditation at the AOAC annual meeting 2011 by Emons, Hendrik, Weitzel, Jane, Budin, John, Phillips, Melissa, Rimmer, Catherine, Zink, Donna

“…[...]groups such as the Analytical Laboratory Accreditation Criteria Committee of AOAC International have developed guides to aid in the interpretation of…”
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The estimation and use of measurement uncertainty for a drug substance test procedure validated according to USP by Weitzel, M. L. Jane

“…The vision for metrology at the United States Pharmacopeia (USP) is for international recognition, harmonization, and official acceptance of all USP reference…”
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Using target measurement uncertainty to determine fitness for purpose by Weitzel, M. L. Jane, Johnson, Wesley M.

“…The methods an analytical laboratory uses must be validated to be fit for purpose. The fitness for purpose of a quantitative method used to determine the…”
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The Value of Pharmacopeial Reference Standards by Zeine, Christian, Podolsky, Doug, Weitzel, Jane, Reddy, Jane, Walfish, Steven L

“…The US Pharmacopeia and other major pharmacopoeias have established that only the combination of documentary standards and pharmacopeial reference standards…”
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Ongoing Analytical Procedure Performance Verification--Stage 3 of USP1220: Analytical procedure performance can be continually verified by risk-based monitoring of performance related data by Borman, Phil, Mahr, Amanda Guiraldelli, Weitzel, Jane, Thompson, Sarah, Ermer, Joachim, Sproule, Stephanie, Roussel, Jean-Marc, Marach, Jaime, Pappa, Horacio

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Ongoing Analytical Procedure Performance Verification-Stage 3 of USP by Borman, Phil, Mahr, Amanda Guiraldelli, Weitzel, Jane, Thompson, Sarah, Ermer, Joachim, Sproule, Stephanie, Roussel, Jean-Marc, Marach, Jaime, Pappa, Horacio

“…For high-risk analytical procedures (see later section for how risk is determined), control-chart monitoring of selected performance data, generated during…”
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