Virtual delivery available!

UPCOMING PROGRAM DATES: This training is scheduled according to demand

Application of Quality by Design (Q-b-D) methodology for product commercialization is increasingly becoming the standard business practice at Pharma and Biotech companies. It is also much sought after by US and EU regulators as an approach presented in regulatory dossier to demonstrate that product will be safe and effective consistently over its lifecycle. While the concept of Quality by Design is universal and commonplace in many sectors, its application in Biotech industry for product commercialization is relatively new and “purpose-built” to suit the nuances of the products and processes.

Program Logistics

Program Start: This training is scheduled according to demand
Registration Deadline: Two weeks prior to program start
Time: 8:00am – 4:00pm
Location: Biomanufacturing Education & Training Center (BETC) WPI Gateway Park 2, 50 Prescott Street (2nd floor), Worcester MA
Cost: $2,925
CEU: 2.3
There are no academic prerequisites for this program

PREREQUISITE

A 2-hour online lecture must be viewed anytime prior to the start of the program.

WHAT YOU WILL LEARN

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 Q-b-D related activities related to a Biotech product.

Introduction to Q-b-D principles- A science- and risk-based approach
Product understanding – Critical Quality Attributes (CQAs) – patient safety and needs
Process understanding
Development of Process and Analytical Control Strategy
Statistical Methods and data analysis
Quality Risk Management (QRM)
Design of Experiments (DOE)
Process Optimization & Response Surface Methodology– Ranges, Design Space,
Root causes analysis – FMEA, risk ranking and apply FMEA to Control Strategy selection
Technology Transfer to manufacturing and Continuous Process Verification Strategy
CASE Studies

Who Should Attend

This 3 day course containing workshops, case studies and Q&A sessions is intended for scientists and engineers who are new to Quality-by-Design and/or need an update in their knowledge of the subject. The course is designed and delivered by a leading industry expert who is engaged on a daily basis with all aspects of Q-b-D, from late phase process design, characterization and Tech Transfer to biomanufacturing, validation and regulatory aspects.

About the Instructor
Naveen Pathak

Naveen Pathak is Director of Process Development at Takeda (formerly Shire). He currently leads a team that owns deployment of QbD and Process Validation. Prior to joining Takeda (formerly 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 20+ years of experience in process development and technical support 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.

He is recognized as a flexible, creative, risk- based decision maker offering a unique combination of technical and people leadership, excellent communication, and understanding of regulatory and compliance landscape.