Journal of Developing Drugs
Open Access

Pharmaceutical product development, manufacturing, & commercialization – Implementing quality by design

Joint International Conference and Expo on Industrial Pharmacy & 5th Global Pharmacovigilance Summit

April 28-29, 2016 Dubai, UAE

Mahmoud El-Khateeb

East Tennessee State University, USA

Posters & Accepted Abstracts: J Develop Drugs

Abstract :

The quality of pharmaceutical/biopharmaceutical products has been usually controlled by the end product testing (Quality Control Release). To better control the product release and increase its scientific compliance with regulatory bodies and meet the customer needs, the concept of quality by design (QbD) becomes the new paradigm to ensure these expectations are met and to minimize the risks associated with the development process, scale-up and commercial productions. In this presentation, the speaker will discuss some critical stages in pharmaceutical industy for clarifications from a scientific/technical point of view including: The concepts to be applied in the design and development of a product and associated manufacturing processes; methods to ensure critical quality attributes, which can be accurately and reliably predicted; knowledge transfer framework to enable the organizational understanding required to drive effective risk management and decision making; systems that must exist to capture and organize knowledge from the continuous processes improvement to acheive the commercial production that meets safety and effectiveness consistently.

Biography :

Email: mahmoud.a.khateeb@gmail.com