Quality by Design (QbD) in Clinical Trials - Build Bullet-Proof Protocols
Clinical trial quality ultimately rests on having a well-articulated investigational plan with clearly defined objectives and associated outcome measures. Quality-by Design (QbD) emphasizes building quality into a process from the beginning, and has been successfully utilized in the manufacturing arena. Applied in clinical development, this approach examines the design and objectives of a trial protocol to identify “Critical to Quality (CTQ)” factors (e.g. key data and trial processes). Understanding what aspects of a trial are “critical to quality” is essential to subsequently identifying and managing risks to trial quality.
This seminar will provide attendees with a strong foundation for identifying and managing important risks to quality in the protocol development process.
Attend this 90-minute interactive session, and you will:
- Learn QbD techniques that you can implement immediately to improve trial quality
- Understand Critical to Quality (CTQ) parameters, and build trial protocols that get results
- Mitigate risks and avoid potentially costly pitfalls and rework
This interactive online course will be highly beneficial to anyone in clinical development and/or clinical research. Those with responsibilities that include protocol development and design – and ensuring trial quality – will find this training particularly useful.
Kenneth Schiff, mMBA, BA is the president/owner of Quality Risk Management Associates, LLC, a consulting firm which specializes in providing risk management support to pharmaceutical and biotechnology companies around the world. With broad expertise in all phases of pharmaceutical development, Quality Risk Management Associates ensures regulatory compliance and minimizes risk across the clinical development process. They have successfully transformed traditional quality assurance methods by spearheading innovative quality risk management and compliance systems and driving new governance and control standards that help business partners proactively identify, manage, and mitigate risk.
Prior to this, Ken joined Hoffmann LaRoche/Genentech in 2006 as the Head of Quality Assurance and Quality Risk Management based in Nutley, NJ USA. He was responsible for overseeing quality assurance support and applying quality risk management concepts in the conduct of clinical trials. He started his career in the pharmaceutical industry in Clinical Quality Assurance at Merck & Co. Inc. in 1990.
Ken has also been an active member of the Clinical Trial Transformation Initiative working closely with the FDA on the BIMO Modernization and Critical Path Initiatives, with specific focus on Quality Risk Management concepts. Mr. Schiff obtained his BA degree in Biological Sciences/Pre-Medicine and MBA Certificate in Biopharma Innovation & Entrepreneurship from Rutgers University.