Managing Pharmaceutical Quality: In And Beyond the COVID-19 Pandemic

Managing Pharmaceutical Quality: In And Beyond the COVID-19 Pandemic

Ajaz S. Hussain, Ph.D.

(The National Institute for Pharmaceutical Technology and Education, Inc. )

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The supply of pharmaceuticals to patients have been on a critical path for decades. Now, this path is more tortuous. Reshoring of the pharmaceutical supply chain is emerging as a vital national security need. Re-shoring traditional know-how and technologies with inherent unpredictability and adverse environmental impact are unlikely to provide security sought, nor will it be competitive and affordable. The challenge is complex and in chaos, akin to reforming professionals and systems1. Are the calls and funding to re-shore sustainable?  What “new prior knowledge”2 is needed? How can we transform and mature systems for quality management?   Why “chaos to continual improvement”3 charts this journey?

1  Gurvich, V.J., Hussain, A.S. AAPS PharmSciTech 21, 153 (2020). https://doi.org/10.1208/s12249-020-01718-9

2  Hussain, A.S., Gurvich, V.J., and Morris, K. AAPS Pharm Sci Tech, 20, 140 (2019). https://doi.org/10.1208/s12249-019-1347-6

3  Hussain, A.S. Chaos to Continual Improvement: Path to Harmonization. CPhI Industry Report 2019: https://www.cphi.com/content/dam/Informa/cphi/en/cphi-insights/HLN19-CPhI%20Insights-2019-Industry-Report.pdf

 

Date and Location

Thurs Sept 17th, 2020

4:00 - 5:00 PM

Meeting Sponsors

BioDuro

Gattefossé

Natoli

Online Meeting

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About the speaker

Dr. Ajaz Hussain holds B.Pharm and Ph.D. degrees from the universities of Mumbai and Cincinnati, respectively, his 30 plus years of unique experience covers academia, the US FDA and industry (Deputy Director, Office of Pharmaceutical Science, US FDA, VP and Global Head Biopharmaceutical Development at Sandoz, Chief Scientific Officer at Philip Morris International and Chief Scientific Officer and President Biotechnology at Wockhardt. Currently, he devotes part of his time to serve as the President of the not-for-profit National Institute for Pharmaceutical Technology and Education. In his advisory practice, he focuses on developing corporations and individual professionals as self-authored architects of evidence they need to make sound decisions efficiently. Typically, he engages with life science companies on challenging problems in product development, manufacturing, quality control, and assurance functions. He is also a member of several Boards, and he also serves as an Adjunct Professor at Long Island University

 

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