TS3A: INTRODUCTION QUALITY BY DESIGN (QBD) FOR BIOPHARMACEUTICALS

MONDAY, AUGUST 12 AND TUESDAY, AUGUST 13
DAY ONE: 1:00 – 5:00 PM | DAY TWO: 8:00 AM – 5:00 PM

Waterfront 1AB

Instructor:

Naveen Pathak, Director, Pharmaceutical Science, Takeda

Quality by Design (QbD) methodologies for product commercialization is increasingly becoming the standard business practice at pharma and biotech companies. QbD elements such as Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Control Strategies are also required by US, EU and other regulators to be including in files to demonstrate that products will be safe and effective and can be consistently produced over its lifecycle.

This 1.5-day course is intended for scientists and engineers who are new to QbD or need an update in their knowledge of the subject. This course will take the students through the journey of using a combination of classroom presentations and case studies such that they will be ready to participate in QbD related activities related to a biologic drug product.

TOPICS TO BE DISCUSSED:

• Introduction to QbD principles- A science- and risk-based approach
• Product understanding & identification of Critical Quality Attributes (CQAs)
• Process understanding & determination of Critical Process Parameters (CPPs)
• Development of Process and Analytical Control Strategy using FMEA based approach
• Process Characterization Strategy and Design of Experiments (DOE)
• Enabling successful PPQ, Tech Transfer, and Approval via QbD deployment

INSTRUCTOR BIOGRAPHY:

Naveen Pathak, Director, Process Development, Takeda

Naveen Pathak is Director of Process Development at Takeda. He currently leads a team that owns deployment of QbD and Process Validation. Prior to joining Shire, Naveen has worked at leading biotech and pharmaceutical companies, including Genzyme, Amgen, DSM, and Novartis in Process Development and Manufacturing Science functions. Naveen is a seasoned biopharmaceutical industry professional with ~ 25 years of experience in process development and technical services spanning non-clinical, clinical, and commercial manufacturing. He has a Masters in Chemical Engineering from University of Oklahoma and Graduate certificate in Quality and Regulatory Affairs from Temple University. Naveen is also actively engaged in teaching QbD related courses at Graduate Schools in US and is an Adjunct Faculty at Keck Graduate Institute in Claremont, CA

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.