GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

  • Risk Management
  • Regulatory Compliances
  • Corporate Governance
  • Quality Management
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Applied Statistics for Scientists and Engineers

Start Date : November 5, 2018
End Date : November 6, 2018
Time : 9:00 am to6:00 pm

Phone : 18004479407
Email : globalcompliancepanel@gmail.com

Location :
Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States

Website

Description

 


Course "Applied Statistics for Scientists and Engineers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


Description:


Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are 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.


Different statistical methods are required for each of these particular applications. 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. Descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used for developing process control charts and developing process capability indices.


This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. Once competence in each of these areas is established, industry-specific applications are presented for the participants.




Why should you attend:


21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods across the product quality lifecycle.


According to the Quality System Regulation (QSR) for medical devices, "Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, verifying the acceptability of process capability and product characteristics." Although there are many statistical method that may be applied to satisfy this portion of the QSR, there are some commonly accepted methods that all companies can and should be using 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.


According to both 21 CFR and guidance documents, the need for statistical methods is well established from discovery through product discontinuation. 21 CFR specifies the "the application of suitable statistical procedures" to establish both in-process and final specifications. The guidance documents necessitate the application of statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring the manufacturing process is in control and is capable.


This course provides instruction statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.




Areas Covered in the Session:


Objectives:


·         describe and analyze the distribution of data


·         develop summary statistics


·         generate and analyze statistical intervals and hypothesis tests to make data-driven decisions


·         describe the relationship between and among two or more factors or responses


·         understand issues related to sampling and calculate appropriate sample sizes


·         use statistical intervals to setting specifications/develop acceptance criteria


·         use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility


·         ensure your process is in (statistical) control and capable


Who Will Benefit:


This seminar is designed for pharmaceutical, biopharmaceutical, and medical device professionals who are involved with product and/or process design:


·         Process Scientist/Engineer


·         Design Engineer


·         Product Development Engineer


·         Regulatory/Compliance Professional


·         Design Controls Engineer


·         Six Sigma Green Belt


·         Six Sigma Black Belt


·         Continuous Improvement Manager


Agenda:


Day 1 Schedule




Lecture 1:


Basic Statistics





Lecture 2:


Intervals





Lecture 3:


Hypothesis Testing





Lecture 4:


ANOVA



Day 2 Schedule




Lecture 1:


Regression and ANCOVA





Lecture 2:


Applied Statistics



Speaker:


Jim Wisnowski





Jim Wisnowski is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. He has over 25 years of experience and currently provides training and consulting services to industry and government in Design of Experiments (DOE), Reliability Engineering, Data Visualization, Predictive Analytics, and Text Mining. Dr. Wisnowski has been an invited speaker on applicability of statistics for national and international conferences. Prior to his current position, he was a senior program manager for URS, Chief of the Statistics Division in the Mathematics Department at the Air Force Academy, and a retired military officer. He is currently a member of the editorial board of Quality Engineering and has published numerous international refereed journal articles on statistics. Jim has a PhD in Industrial Engineering from Arizona State University.


 


Location:  Boston, MA Date: November 5th & 6th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States


Price:


Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird) Until September 20, Early Bird Price: $1,295.00 From September 21 to November 03, Regular Price: $1,495.00


Sponsorship Program benefits for seminar


For More Information- https://www.globalcompliancepanel.com/control/sponsorship


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901627SEMINAR?seo


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Registration Info

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901627SEMINAR?meetings4docs-nov-seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC - DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

  • Risk Management
  • Regulatory Compliances
  • Corporate Governance
  • Quality Management
Tel: 8004479407
Email: globalcompliancepanel@gmail.com
Website: http://www.globalcompliancepanel.com


Event Categories: Cardiology.




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