Event | 18 May, 2022
Lunch & Learn, Boston
Title: Modern Approaches to Data Management Challenges in BioPharma Development and Manufacturing
Time: 11:30am – 1:30pm ET
Location: Commonwealth | Cambridge, Boston
Your Challenge
Gain key insights on the value of using purpose-built software systems to streamline your critical manufacturing data management and product quality processes across internal and external networks.
Speakers:
- Alnylam: Eric Dahlgren, Director of MST
- Vertex Pharmaceuticals: Syama Abhibhatta, PhD, Sr. Director of Quality Analytics
- J&J: Nasir Khan, Senior Director of CMC Portfolio Delivery Optimization
- Plus: Aventior: Abhay Ray, Co-Founder and CTO
What You’ll Learn
Expect to leave this Lunch & Learn with new insights on:
- Using purpose-built data management systems to replace paper and spreadsheets and/or complement large enterprise systems, including accelerating process control strategies, scale-up, tech transfer, batch analysis and trending.
- Drive a successful FDA CPV (Continued Process Verification) and CPI program.
- Requirements for selecting data management solutions that maintain quality, compliance and data integrity across your manufacturing network.
- PIMS customer use cases, presented by industry experts from Alnylam, Vertex and J&J
- PLUS a special presentation by Aventior on using an AI-assisted approach to digitize paper batch records.
- Introduction and demo of IDBS’ Skyland PIMS® (Process Information Management System).
Who Should Attend
Heads of Manufacturing, Operations, Quality, Compliance and IT. Process Engineers, Technical Operations, CMC, MSAT, Data Science, Informatics and Digital Data/Transformation leadership who identify with one or more of the following:
- Have products in Phase II, Phase III, and/or Commercial manufacturing
- Preparing for PPQ (Process Performance Qualification) runs, process validation, technology transfer and/or Continued Process Verification (CPV)
- Have outgrown paper- and spreadsheet-based data management processes
- Sponsors and CMOs interested in establishing shared data visibility
Background
Paper, spreadsheets, and disparate digital systems present a host of issues when managing manufacturing process data including lost time, breakdown in data integrity, and delayed analytics and reporting. These are compounded by the reliance on CMO data. Join us to discuss best practices for addressing this challenge and explore the use of innovative Process Information Management Systems (PIMS) to streamline process data management with higher data integrity, support accelerated development, clinical and manufacturing schedules, and drive collaboration among internal and external teams.
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