Quality by Design using Design of Experiments (QbD) 2017

Start Date : December 4, 2017
End Date : December 5, 2017
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : john.robinson@globalcompliancepanel.com

Location :
Embassy Suites Boston Logan Airport 207 Porter St, Boston, MA 02128, USA

Website

Description









 


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


Overview:


 


This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.


Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program.


This systematic understanding should include both identification of significant process parameters and determination of a functional relationship (mathematical model) linking these significant process parameters to the critical quality attributes (CQAs). The original guidance document on pharmaceutical development provides general guidance on how these are identified: gaining knowledge about which variation in factors explains variation in product quality characteristics of drug product. It also provides a means to achieving this knowledge: through the use of formal experimental designs. The use of DOE methodology provides a means to identify those factors that impact product quality characteristics of drug product (or significant process parameters) and determine the functional relationship that links the process parameters to the CQAs.


Although the seminar focuses on the use of DOE for QbD, multiple aspects of QbD are integrated into the course. After learning the relevant applied statistics, participants will understand how statistics can be used to help set specifications and analyze measurement systems, two foundational requirements of QbD. Next participants will learn tools to help them get value out of their designed experiments. Then, participants will learn how to generate and analyze both screening and response surface designs for QbD studies. Lastly, participants will learn how to use this information: best practices on presentation, setting control plans, constructing control charts, and evaluating process capability.


Analyses in this course use the point-and-click interface of JMP software.


 


Why should you attend:


 


As stated in Q8, the ICH guidance document on pharmaceutical development, drug product should meet its intended product performance as well as meet the needs of patients. Although the strategy for pharmaceutical development may vary from company-to-company and/or from product-to-product, a systematic approach defined by quality by design (QbD) principles is encouraged.


Further guidance and policies have been provided to explain how the QbD approach should be integrated into the pharmaceutical quality system including process design, qualification, continued process verification, risk management, and validation. Although guidance on implementation of these requirements is prevalent, many companies have not yet implemented QbD into their quality systems; regulatory agencies have made it clear this will change. In fact, the chemistry, manufacturing, and controls (CMC) reviewers in the Office of Pharmaceutical Science (OPS) released a manual on policies and procedures (MAPP) explaining how reviewers will begin to enforce the requirements from these guidance documents. Additionally, the Director of the Center for Drug Evaluation and Research (CDER) at the FDA (May 2014) co-authored a paper in The American Association of Pharmaceutical Scientists detailing the concept and reiterating the importance of using a QbD approach to pharmaceutical development. This seminar will demonstrate how to integrate those QbD principles into a pharmaceutical quality system.


 


Areas Covered in the Session:


 


implement QbD principles from discovery through product discontinuation


apply statistics to set specifications and validate measurement systems (assays)


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)


establish your design space


develop a control plan as part of a risk management strategy


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


 


Who Will Benefit:


 


This seminar is designed for pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control.


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:


Introduction to Quality by Design (QbD)


Quality by Design (QbD) principles


Product Quality System framework


Primer on Statistical Analysis


basic statistics


Lecture 2:


Primer on Statistical Analysis (cont.)


hypothesis testing


Lecture 3:


Primer on Statistical Analysis (cont.)


ANOVA


Lecture 4:


Primer on Statistical Analysis (cont.)


Regression


 


Day 2 Schedule


 


Lecture 1:


Foundational Requirements for QbD Studies


setting specifications


Measurement Systems Analysis (MSA) for assays


Introduction to Design of Experiments (DOE)


steps to DOE


defining critical-to-quality attributes (CQAs)


identifying and prioritizing potential process parameters


Screening Designs - Identifying Critical Process Parameters


factorial designs


Lecture 2:


Screening Designs - Identifying Critical Process Parameters (cont.)


fractional factorial designs


D optimal


Lecture 3:


Response Surface Designs - Develop Functional Relationships and Establish Design Space


Addition of center points


Central Composite Designs (CCD)


I optimal designs


Lecture 4:


Utilizing Systematic Understanding from QbD Studies


presenting results


developing a control plan as part of a risk management strategy


process control and capability


 


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: Boston, MADate:  December 4th & 5th, 2017 and Time: 9:00 AM to 6:00 PM


Venue:    Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA


 


 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 October 20, Early Bird Price: $1,295.00 From October 21 to December 05, Regular Price: $1,495.00


 


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=901134SEMINAR?meetings4docs-December-2017-SEO


 


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

Tel: Event Manager
Mobile: 800-447-9407
Email: john.robinson@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com


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