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Throughout 21 CFR and guidance documents for the pharmaceutical\, biopharmaceutical\, and medical device industries\, the application of statistical methods ar e specified for: setting validation criteria and specifications\, performi ng measurement systems analysis (MSA)\, conducting stability analysis\, us ing design of experiment (DOE) for process development and validation\, de veloping process control charts\, and determining process capability indic es.
\n\nDifferent statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools us ed for setting acceptance criteria and specifications. Simple linear regre ssion and analysis-of-covariance (ANCOVA) are used for setting expiries an d conducting stability analysis studies. Two-sample hypothesis tests\, ana lysis-of-variance (ANOVA)\, regression\, and ANCOVA are methods used for a nalyzing designed experiment for process development and validation studie s. Descriptive statistics (distribution\, summary statistics)\, run charts \, and probability (distributions) are used for developing process control charts and developing process capability indices.
\n\nThis course p rovides instruction on how to apply the appropriate statistical approaches : descriptive statistics\, data intervals\, hypothesis testing\, ANOVA\, r egression\, ANCOVA\, and model building. Once competence in each of these areas is established\, industry-specific applications are presented for th e participants.
\n\n21 CF R and guidance documents for the pharmaceutical\, biopharmaceutical\, and medical device industries specify the application of statistical methods a cross the product quality lifecycle.
\n\nAccording to the Quality Sy stem Regulation (QSR) for medical devices\, "\;Where appropriate\, eac h manufacturer shall establish and maintain procedures for identifying val id statistical techniques required for establishing\, controlling\, verify ing the acceptability of process capability and product characteristics.&q uot\; Although there are many statistical method that may be applied to sa tisfy this portion of the QSR\, there are some commonly accepted methods t hat all companies can and should be using to develop acceptance criteria\, to ensure accurate and precise measurement systems\, to fully characteriz e manufacturing processes\, to monitor and control process results and to select an appropriate number of samples.
\n\nAccording to both 21 CF R and guidance documents\, the need for statistical methods is well establ ished from discovery through product discontinuation. 21 CFR specifies the "\;the application of suitable statistical procedures"\; to estab lish both in-process and final specifications. The guidance documents nece ssitate the application of statistical methods for development and validat ion of measurement systems\, process understanding using Quality by Design (QbD) principles\, process validation\, as well as ensuring the manufactu ring process is in control and is capable.
\n\nThis course provides instruction statistical methods for data analysis of applications related to the pharmaceutical\, biopharmaceutical\, and medical device industries.
\n\nThis sem inar is designed for pharmaceutical\, biopharmaceutical\, and medical devi ce professionals who are involved with product and/or process design:
\ n\nLecture 1:
\nLecture 2:
\nIntervals\n\n< ul>\nLecture 3:
\nHypo thesis Testing\n\nLecture 4:
\nLecture 1:
\nRegression and ANCOVA\n\nLecture 2:
\nApplied Statistics< /strong>\n\n \;
\n\n\ nHeath Rushing \;is the cofounder of Adsurgo and author of the book \;Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. \;Previously\, he was th e JMP and Six Sigma training manager at SAS. He led a team of nine technic al professionals designing and delivering applied statistics and quality c ontinuing education courses. He created tailored courses\, applications\, and long-term training plans in quality and statistics across a variety of industries to include biotech\, pharmaceutical\, medical device\, and che mical processing. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences. As a Quality En gineer at Amgen\, he championed statistical principles in every business u nit. He designed and delivered a DOE course that immediately became the co mpany standard required at multiple sites. Additionally\, he developed and implemented numerous innovative statistical methods advancing corporate r isk management\, process capability\, and validation acceptance criteria. He won the top teaching award out of 54 instructors in the Air Force Acade my math department where he taught several semesters and sections of opera tions research and statistics. Additionally\, he designs and delivers shor t courses in statistics\, data mining\, and simulation modeling for SAS. p>\n\n
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