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Quality by Design using Design of Experiments (QbD) 2017- Before 30 April 50% Discount for its All Seminars

Added by globalcompliancepanel on 2017-04-11

Conference Dates:

Start Date Start Date: 2017-06-12
Last Date Last Day: 2017-06-13
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2017-06-11

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email:
Address Address: Mandarin Orchard Singapore, Singapore, 238867, Singapore
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

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 a 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 you should 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

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