GlobalCompliancePanel announces in-person seminar on the topic, “Applied Statistics for Scientists and Engineers”. Heath Rushing, Co-founder and Principal, Adsurgo, will be the speaker at this seminar. The speaker at this seminar will provide instruction on statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.
Fremont, CA: GlobalCompliancePanel, a leading provider of regulatory compliance trainings for a wide range of regulated industries, will organize a two-day seminar in Zurich, Switzerland on July 16th and 17th, 2015. The topic of this seminar is “Applied Statistics for Scientists and Engineers”.
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
About the seminar:
The application of statistical methods is specified for setting validation criteria and specifications, performing Measurement Systems Analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries.
Each of these particular applications requires different statistical methods. While data and tolerance intervals are common tools used for setting acceptance criteria and specifications; simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies, while descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used for developing process control charts and developing process capability indices.
For more information or to register for the seminar, please click here.
This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. The establishment of competence in each of these areas and industry-specific applications are presented.
21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods across the product quality lifecycle. Although there are many statistical methods that may be applied to satisfy this portion of the QSR, there are some commonly accepted methods that all companies can and should use to develop acceptance criteria, to ensure accurate and precise measurement systems, to fully characterize manufacturing processes, to monitor and control process results and to select an appropriate number of samples. This course provides instruction on these.
About the Speaker:
Heath Rushing is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences.
As a Quality Engineer at Amgen, he championed statistical principles in every business unit. He designed and delivered a DOE course that immediately became the company standard required at multiple sites. Additionally, he designs and delivers short courses in statistics, data mining, and simulation modeling for SAS.
GlobalCompliancePanel (http://www.globalcompliancepanel.com/) is a specialized offering from NetZealous, a Fremont, CA-registered organization. It is a source for a wide range of professional trainings, compliance trainings and consulting for the regulated industries. GCP offers a broad range of high quality regulatory and compliance-related services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.
GlobalCompliancePanel has many well-known names among its clients. These include Bristol-Myers Squibb, Roche, Merck, Baxter, Johnson and Johnson, Pfizer, Abbot, Boehringer Ingelheim, Bayer, Molina Healthcare, Pfizer, Alcatel-Lucent, American Express, Medtronic, Lonza, Emerson Hospital, GlaxoSmithKline, Novartis and many more.
Over 50,00 professionals in the various areas in which GlobalCompliancePanel offers its trainings have benefited from the vast experience of its well-known speakers, who are reputed globally in their respective fields.