Managing Pharmaceutical Quality over a Product's Life-Cycle: Challenges & Solutions

Ajaz S. Hussain, Ph.D.

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

Pharmaceuticals are evidence-based medicinal products, better than placebo. A pharmaceutical quality management system or pQMS maintains orderly operations by controlling the material quality of marketed pharmaceutical medicines to reliably deliver products and the assurance expected by patients to experience therapeutic outcomes claimed on its label. Since the U.S. FDA’s 21st-century initiative, an emphasis was placed on industry adopting a systems approach, and despite the adoption of ICH Q10: Pharmaceutical Quality System guidance in 2009, the challenge we confront today is that pQMS in many corporations have not matured. That is to an extent to justify benefiting emerging regulatory flexibility for the continual improvement of their operations as described in recent guidelines (e.g., ICH Q12). The solution to this challenge is to improve investigations of deviations and OOS observations to achieve stable and capable processes; only then can we begin a journey to continual improvement. Using real-world case examples, this presentation will elaborate on the stated challenges and proposed solutions.

Date and Location

Thurs Mar 19th, 2020

Registration & social hour: 5:30 PM

Dinner & presentation: 6:30 PM

Meeting Sponsors




Hanover Marriott

1401 Rt 10 E, Whippany, NJ07981

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


Registration Fees

  • Registered and paid online:     $50.00
  • Walk-in:     $65.00
  • Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY):     $45.00

Advance registration will end at 5:00 PM on WEDNESDAY MAR 18th;  after that, you must pay at the door.  Note also that if you choose the "Register and Pay at Meeting" option, you must proceed all the way to the "Your Order is Confirmed" screen or your registration will not be recorded.

Note: in the event a meeting needs to be cancelled due to weather or other conditions, NJPhAST will do its best to notify all registrants as soon as possible; however, we ask that you exercise individual judgement if you do not hear directly from NJPhAST.

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