Quality by Design using Design of Experiments (QbD)

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.

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