Digital Validation - Why BioPharma is Going Paperless
Alton Johnson, Ph.D. (Alton Johnson Consulting LLC)
Advanced Digital Validation Lifecycle Management Systems (VLMS) have been available for over 15 years but have only come into widespread use within the past 5-10 years. VLMS are now in use across well over one hundred life sciences companies, including most major pharmaceutical companies. Comprehensive implementation across Pharma presents a compelling opportunity for operational, business and compliance excellence. This NJPhAST session provides insights into the benefits of digital VLMS including lower cost, faster implementation as well as reliable data integrity and compliance. The COVID-19 pandemic presented critical challenges to pharmaceutical supply chains and revealed the need and opportunity for remote working solutions. Digital VLMS is a key enabler for remote two-person verification of GMP operations, internal and external audits, and for regulatory inspections. This presentation advocates digital VLMS as an emerging necessity to expand benefits beyond the well documented business advantages of VLMS.
Date and Location
Thurs May 20th, 2021
4:00 - 5:00 PM
About the speaker
Current role: Pharmaceutical Consultant in new product & process development, manufacturing technology, supply chain and compliance
Experience - Pfizer Inc:
• 30+ years leadership of new product & process development, technology transfer and manufacturing technology across drug substance and drug product for oral solid dosage, aseptic small molecules and biologicals
• Established business processes for Accelerated Development, Quality by Design, Risk Management, Control Strategy, Knowledge Management, Technology Transfer, Automated Quality Verification and Lifecycle Management
• Industry leader in Pharma 4.0 / digital transformation / manufacturing intelligence
• PhD Industrial & Physical Pharmacy, Purdue University, School of Pharmacy
• BS Pharmacy, University of North Carolina at Chapel Hill
• ISPE (International Society of Pharmaceutical Engineers)
• Board Member, Smart Manufacturing Leadership Coalition (2010 – 2018)
• Chair, Steering Committee, Engineering Research Center for Structured Organic Particulate Systems (2006 – 2015)
• PhRMA (Pharmaceutical Research & Manufacturing Association)
- Manufacturing and Quality Working Group, 2018-2019
- Vice Chair & Secretary, Technical Leadership Committee, 2008 - 2009
- Chair, Vice Chair, Secretary, Drug Product Technical Group, 2003 – 2007
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- There is no registration fee for this event.