Simplifying Change Management Across the Product Lifecycle

An FDAnews FREE Webinar • Co-Sponsored by Veeva Systems and Axendia
Thursday, March 29, 2018 • 1:00 p.m. – 2:00 p.m. EDT

Deterred by the complexity, time, and cost, many companies avoid or are slow to make changes. For organizations that have global and outsourced operations, extra consideration is needed for regional differences and market specific regulatory requirements.

Change management programs also struggle with identifying clear roles and responsibilities, properly and thoroughly assessing risk and root cause, and often the overwhelming number of SOPs. Modern solutions enable a consistent and repeatable change management process that engages all parties for complete impact assessments and seamless execution — allowing companies to decrease risk, improve product quality, and achieve agile decision-making.

Learn change management best practices and how to leverage technology for an effective and efficient change control process, including:

  • Roles and responsibilities
  • A framework to systematically assess global operational and regulatory impact
  • Structuring and implementing change releases in a global environment
  • Streamlining processes between departments like quality and regulatory
  • Gaining better intelligence to improve decision-making

Who Will Benefit

  • Quality
  • Regulatory Affairs
  • Contract and External Manufacturing
  • Commercial operations
  • Research and Development
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Meet Your Presenters


Mike Jovanis

VP-Vault Quality
Veeva Systems

Mike Jovanis, VP-Vault Quality, Veeva Systems. As Vice President of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as vice president of product management and strategy for Sparta Systems, where he was instrumental in the company's rapid growth, driving product development, vertical market strategy, and strategic partner alliances. Educated at Rutgers, he holds a bachelor’s degree in marketing and an MBA in strategy and global business.


Daniel R. Matlis

Founder and President

Daniel R. Matlis, Founder and President, Axendia. Dan’s firm specializes in advising regulated life science and healthcare firms on business, technology and regulatory matters. With 25+ years of experience focusing on the health sciences value chain, he has extensive leadership experience in areas including technology, regulatory compliance, and business. His background includes a B.S. in electrical engineering and an M.S. in technology-focused management.