|
|
PDA Workshop: Quality by Design – Putting Principles into Practice is a workshop which stresses upon API, Parenteral manufacturing, drug product and the ways to reduce costs maintaining quality. The current theme of this edition of the workshop will be: Quality by Design: A Step to Saving Costs. The workshop will give an immense opportunity of learning Quality by Design in a step-by-step method. More to it, the event will have real applications for the development of chemical, pharmaceutical and analytical products. Informal meetings and lectures will be arranged to acquaint with the latest advancements in these sectors.
The salient features at PDA Workshop: Quality by Design – Putting Principles into Practice are:
- EFPIA's Mock documents for QbD applied to Developing Biotech and Injectable Products
- QbD - Application to Biotech Processes and Information Transfer
- QbD and Real-Time-Release Testing
- QbD in Formulation and Process Development For a Freeze-Dried Parenteral, a case study made in cooperation with FDA
- QbD/PAT implementation in drug product manufacturing for an already marketed commercial product and the tools applied
- Parametric/real time release testing achieved using rapid microbiology methods as a QbD Tool
- Case study of an integrated QbD approach for science- and risk-based process development from an API to a Drug Product
Visitor Profile
The expected visitors at the PDA Workshop: Quality by Design – Putting Principles into Practice are from the following categories:
- Quality Professionals
- Professionals in Documentation
- Professionals in Chemical/ Pharmaceutical/Analytical Development
- Professionals in Pilot Plant and Commercial Manufacturing
- Professionals in Engineering Sector
- Professionals in Validation
Organizer
PDA Europe gGmbH
