2014 - Seven Opportunities of Quality by Design (QbD)

Instructor: Heath Rushing
Description:
This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles. In addition, this webinar teaches the application of statistics for setting specifications, assessing measurement systems, 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.
Learn How to:
Implement QbD principles from discovery through product discontinuation
Apply statistics to set specifications and validate measurement systems
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.
These are the same concepts detailed and explained by the Director of CDER at the FDA in a recently published (May 2014) paper in The American Association of Pharmaceutical Scientists. 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.
Why Should you Attend:
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) recently released a manual on policies and procedures (MAPP) explaining how reviewers will begin to enforce the requirements from these guidance documents. In fact, the Director of the Center for Drug Evaluation and Research (CDER) at the FDA recently (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 webinar will demonstrate how to integrate those QbD principles into a pharmaceutical quality system.
Objectives of the Presentation:
Quality by Design
Setting specifications
Measurement systems analysis (MSA)
Determining critical quality attributes (CQAs) and process input parameters
Process development using design of experiments (DOE)
Control or risk management plan
Process validation
Commercial manufacturing
Who can Benefit:
This webinaris designed for pharmaceutical, biopharmaceutical, and medical device 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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