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Global List Event

Design of Experiments (DOE) for Process Development and Validation 2017

NetZealous DBA as GlobalCompliancePanel

Course "Design of Experiments (DOE) for Process Development and Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product.

The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes. Screening designs, such as 2k factorial and D-optimal designs, are used to determine critical process parameters. Response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs, are used to model the functional relationship between those critical process parameters and the critical quality attributes.

This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs; the participants will leave with an understanding of why and how each are used. Then, the participants will learn how results of the studies can be presented. Lastly, using the results of the studies, the risk management tools will then be updated.

 

Why you should attend:

 

The Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers provides guidance on where design of experiments should be applied during process validation; it suggests the use of both screening and response surface designs during Operational Qualification. In addition, DOE should be used during multiple phases of design controls: design and development planning, design verification, design validation, design transfer, and design changes.

In Guidance for Industry Q8 Pharamaceutical Development (as well as the annex to Q8), suggests applying experimental design to demonstrate "...an enhanced knowledge of product performance over a range of...process parameters." Using this "...enhanced, quality by design approach..." leads to greater system understanding. That greater system understanding has two elements: identifying critical process parameters and developing a functional relationship that link those critical process parameters to your critical quality attributes (CQAs). This suggests the use of both screening and response surface designs during pharmaceutical development studies.

The need for DOE in product and process development is not only suggested, but imperative for both medical device and drug manufactures.

 

Areas Covered in the Session:

 

Learn how to effectively use JMP to:

         identify critical quality attributes (CQAs) that will be used as responses in your designs

         utilize risk management tools to identify and prioritize potential critical process parameters

         identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using both screening and response surface designs

         be able to design and analyze screening designs including a factorial, fractional factorial, and D-optimal design

         understand the need for adding center points to a design

         be able to design and analyze response surface designs including central composite designs (CCDs), Box-Behnken designs, and I-optimal designs

         present results of DOE studies

         use systematic understanding from DOE studies to update the control plan that is part of the overall risk management plan

 

Who Will Benefit:

 

This webinar 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:

Primer on Statistical Analysis

  • basic statistics
  • two-sample t-test
  • ANOVA
  • regression

Lecture 2:

Introduction to Design of Experiments (DOE)

  • steps to DOE
  • defining critical quality attributes (CQAs)/responses
  • identifying and prioritizing potential process parameters

Lecture 3:

Screening Designs

  • full factorial designs
  • 2k factorial designs

 

Day 2 Schedule

 

Lecture 1:

Screening Designs (continued)

  • fractional factorial designs
  • D-optimal designs

Lecture 2:

Response Surface Designs

  • 2k factorial designs with center points
  • Central Composite Designs (CCDs)
  • Box-Behnken designs
  • I-optimal designs

Lecture 3:

Utilizing Systematic Understanding from DOE Studies

  • presenting results
  • control plan/risk management strategy

 

 

Speaker

Heath Rushing

Co-founder and Principal, Adsurgo 

 

Heath Rushing 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. Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine technical professionals designing and delivering applied statistics and quality continuing 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 chemical processing. 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 developed and implemented numerous innovative statistical methods advancing corporate risk management, process capability, and validation acceptance criteria. He won the top teaching award out of 54 instructors in the Air Force Academy math department where he taught several semesters and sections of OR and statistics. Additionally, he taught Operations Research and simulation modeling at the Colorado School of Mines and designs and delivers short courses in statistics, data mining, and simulation modeling for SAS.

 

Location: Las Vegas, NV Date:  September 28th & 29th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:   DoubleTree by Hilton Las Vegas Airport   7250 Pollock Drive Las Vegas, NV USA 89119

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 20, Early Bird Price: $1,295.00 From August 21 to September 26, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

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

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: 1-800-447-9407

Phone: 1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901126SEMINAR?globaleventslist-September-2017-SEO

 

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Sep 2017
28
Sep 2017
29

Address details

7250 Pollock Drive Las Vegas, NV USA 89119
Las Vegas, NV, 89119
United States

Location information

DoubleTree by Hilton Las Vegas Airport