DAY 2 - TRAINING
DR JEFF DUKE
The implementation of Quality by Design (QbD) provides Cost-efficient approach to assure safe,
efficient & high quality drug supply to the consumers and promises to improve manufacturing
quality performance.The regulatory authorities European Medicine Agency (EMA) and the U.S
Food and Drug Administration (FDA) have also placed emphasis on QbD as a part of regulatory
filling. The pharma companies applying Quality by Design (QbD) Principles for new and existing
drugs are reporting considerable business benefits such as reduced operating cost, improved,
more efficient manufacturing processes and better meet the regulatory expectations.
This course in QbD is designed to help delegates understand the underlying philosophies
behind QbD, regulatory expectations as well as giving hands on training in the most common
tools and techniques utilised in QbD.
The objective of the course is to provide scientists with the tools and understanding needed to apply QbD confidently in their projects as well as helping mangers and senior managers understand the rationale for applying QbD and overcome potential issues that they commonly face.
Speakers for the event
Head-QbD,Scale-up and Tech Transfer
Dr. Amrendra Kumar Roy
Associate Director – Corporate Quality Assurance
Mylan Laboratories Limited
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