Digitization Of Validation

Digitization Of Validation For Effective Off-Site Regulatory “Review” And “Inspection”

This week, Stacey is joined by Ajaz Hussain, Alton Johnson, and Steve Thompson. As agencies like the FDA continue to rely on virtual inspection, we need to take a look at the process, including a review of documents and processes. How can these inspections be more hands-on and eyes-on, allowing for efficient and accurate outcomes?

Resources from this episode Article - https://www.ivtnetwork.com/article/digitization-validation-effective-site-regulatory-%E2%80%9Creview%E2%80%9D-and-%E2%80%9Cinspection%E2%80%9D

Dr. Ajaz Hussain, Ph.D., Advisory Board Chairman, ValGenesis, Inc.

Dr. Hussain is globally recognized for his tireless efforts to improve the predictability of medicinal product development, manufacturing, and associated regulatory processes. As the Deputy Director Office of Pharmaceutical Science, he led some of the U.S. Food and Drug Administration's major initiatives to develop regulatory policies that already have and will continue to have, a significant impact on product development and approval in many geographies. His corporate experience includes leadership of the development and/or regulatory submissions of first-in-class Biosimilar, Follow-on Protein, and Complex Generic products at Sandoz. At Philip Morris International, he took on the challenge of higher levels of uncertainty (regulatory and business) and product complexity to build strategies and systems to successfully move forward development programs on plant-based vaccines, products for tobacco harm reduction, and ensure the credibility of scientific evidence to seek regulatory discussions and submissions. His experience at Wockhardt has helped him to understand the opportunities and talent companies in India have, the challenges they face, and how they can bring forward effective solutions to maintain and enhance competitiveness and credibility. He also has extensive teaching experience, he served as a tenured Associate Professor of Pharmaceutics at the University of Cincinnati, where he established a research program on Computer-Aided Formulation Design. Based on his broad experience in academia, US FDA, and industry he founded his consulting practice Insight Advice & Solutions LLC.

Alton Johnson, Ph.D., Alton Johnson Consulting, LLC

Alton Johnson is an industry leader and expert in pharmaceutical development, manufacturing, technology, and business solutions. In his current consulting role, he develops strategies and solutions for clients in the areas of new product development, manufacturing, digital transformation, pharmaceutical technology, business development, and compliance. He has 30-plus years of leadership experience at Pfizer across, Technical Services, Innovation, and Advanced Manufacturing Technology / Pharma 4.0. His extensive publications and presentations encompass Quality by Design, Risk Management, Knowledge Management, Validation, Process Analytical Technology, Continuous Processing, and Pharma 4.0, for organizations including ISPE, DIA, PDA, and AAPS. He has served in leadership roles for PhRMA, on the board of Smart Manufacturing Leadership Coalition, and as Chair of the Steering Committee for NIH-sponsored Engineering Research Center.

Steven D. Thompson

Steve has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that include biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and is a regular speaker on industry trends and best practices.

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