The PDA New England Chapter would like to warmly invite you to join us for our 2023 Dinner Meeting Communications & Azzur Cleanroom Tour on 27 April in Devens, MA.
Azzur Cleanrooms on Demand Devens
45 Jackson Road
Devens, MA 01434
When: 4:30PM - 5:30PM
Mary Keville Consulting, LLC
PDA NE Event Meeting Phase #1, Meeting Topic #1
Topic Title: Quality Management Maturity – A Framework for Improving Quality and Patient Safety and Reducing Costs
Quality management maturity is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement – CDER. A Quality Management Maturity (QMM) Assessment holistically assesses the overall health of a quality management system and provides insight into the prevailing quality culture. Included in this presentation:
- Recent efforts by the FDA to secure drug supply chains with the piloting of CDERs QMM program.
- QMM framework: an essential element in charting a course for sustained quality improvement.
- Case studies
- How companies can use the QMM framework to improve quality, maximize patient safety, and reduce costs
Jim Morris, BS, MBA, VP of Health Sciences Consulting, NSF
Jim has over 35 years of experience in the pharmaceutical industry. He has held senior level positions in Quality at several companies including Pfizer, J&J and Massachusetts Biologic Labs. He is currently VP of Health Sciences Consulting at NSF (former David Begg Assoc.) where he and the NSF team of consultants provide expert advice in QA/QC, Regulatory CMC and GMP / Regulatory remediation support. NSF Health Sciences is well known for their global GMP training services and Qualified Persons training in Europe. NSF partners with clients on various technical and quality-based projects, spanning traditional drugs, biologics, and combination products. Jim holds a BS in Biological and Physical Sciences from Northwestern and an MBA from Boston University.
Varun Venkatachalam, MS, Principal Consultant, Pharma/Biotech Consulting, NSF
Varun is passionate about Quality Management Maturity and Human Performance in the Lifesciences Manufacturing sector. With over 13 years of experience across Industry (Hospira & Pfizer) and Management Consulting (PwC & EY), Varun is a multifaceted professional with Operational (Strategy and Operational excellence) and Technical (Regulatory, Quality and Manufacturing Systems) expertise. He is currently a Principal consultant in the Pharma/Biotech Consulting team at NSF international, based out of Toronto. Varun is a Biotech Engineer by training and has a MS in Biotechnology from the University of Warwick. He is currently pursuing his Global Executive MBA in Healthcare/Life Sciences at the Rotman School of Management, UofT.
PDA NE Event Meeting Phase #2, meeting topic #2
Topic Title: Accelerating Early Phase Development Through Hybrid Manufacturing
Traditionally, biomanufacturing innovators have two choices for early clinical trial manufacturing: build or broker. With more and more virtual companies on the scene, the capital expense and time needed for building is a non-starter. Today, hybrid options exist that allow a risk-based approach to early phase clinical manufacturing. This presentation will:
- Explore the different options for biologics development and manufacturing
- Share results of a 2022 research study outlining the insights and challenges of today’s bio manufacturers
- Present blended solutions to traditional development and manufacturing options
Ravi Samavedam, Chief Innovation Officer, Azzur Group
Ravi Samavedam, Chief Innovation Officer at Azzur, is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Prior to his current role, he was President and COO of Azzur Cleanrooms on DemandTM . In 2019, Ravi was a General Manager of Azzur Boston, and has been with the company since 2012. Prior to Azzur, Ravi has been part of the Technical Operations, Quality/Validation departments at Baxter, Amgen, and Shire.
Ravi is an expert in phase-appropriate cGMP implementation, Process Validation, Supplier Management, and Technology Transfer. Ravi is an active member of industry and peer groups, and he is a frequent speaker at industry events.