Module 3 Presentations

07/05/2024

What is our Aim? QTPP in Mind! Waterfall or Agile PM?

Quality Target Product Profile = QTPP

GOAL: -> Identification and understanding of Critical Quality Attributes (CoAs) and Critical Process Parameters (CPPs)

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

25

Quality by Design (QbD) in Product Development

 Applying QbD during drug development is more and more expected by regulatory authorities.  The use of QbD elements is required by the FDA and the EMA since respectively 2011 and 2012.

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

26