Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Heath Rushing

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
– 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.

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 required. 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.

Areas Covered in the Session:
– 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 Will Benefit:
– 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

Heath Rushing is the cofounder of Adsurgo and 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 operations research and statistics. Additionally, he designs and delivers short courses in statistics, data mining, and simulation modeling for SAS.