Critical Quality Attribute Monitoring and Control in Pharmaceutical Manufacturing II

Chair(s):
Wu, H., FDA/CDER
Co-chair(s):
Akiti, O., Relypsa, Inc

Developing robust pharmaceutical production processes to ensure patient safety and drug efficacy is dependent on the sound understanding and control of the drug substance and drug product quality attributes relevant for clinical performance and drug product manufacture. This understanding is then translated into the design of the manufacturing process and a relevant monitoring and control system to ensure that quality attributes within the desired ranges are consistently obtained. This session covers both drug substance and drug product critical quality attribute identification, characterization, and monitoring systems for quality and manufacturing process control. Authors are encouraged to highlight clinically relevant specifications for pharmaceutical products and innovative control strategies for drug substance and drug product manufacturing.

Papers:

Checkout

Paper abstracts are public but to access Extended Abstracts, you must first purchase the conference proceedings.

Checkout

Do you already own this?

Pricing


Individuals

2017 Annual Meeting
AIChE Members $150.00
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $225.00
Pharmaceutical Discovery, Development and Manufacturing Forum only
AIChE Members $100.00
AIChE Food, Pharmaceutical & Bioengineering Division Members Free
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
Non-Members $150.00