Managing Quality in a Global and Outsourced Ecosystem
Managing Quality in a Global and Outsourced Ecosystem |
Wednesday, March 30, 2016 • 1:30 p.m. - 2:30 p.m. EDT • An FDAnews FREE Webinar |
Your Expert Presenters
Daniel R. Matlis, President, Axendia
Dan is president of Axendia, a leading industry analyst firm providing trusted advice to life science executives on business, technology and regulatory matters. He has over 25 years of experience in the life sciences industry spanning R&D, regulatory compliance, commercial operations, quality, and information technology. Dan is an active member in FDA’s Case for Quality Initiative and has presented Axendia’s research findings to industry executives and the FDA. Dan began his career at Johnson & Johnson, where he held various leadership roles and developed standardized processes to streamline operations and compliance, and mitigate risks.
Ethan Smith, Director of Product Strategy, Vault QualityDocs at Veeva Systems
Ethan Smith is the Director of Product Strategy for Vault QualityDocs at Veeva Systems where his primary responsibility is to define product strategy for the Quality function of the Life Sciences industry. Ethan has a track record of developing and delivering innovative solutions to top tier Life Sciences organizations having extensive experience in Content Management and Business Process Management. He has experience across the Life Sciences value chain from research and development to commercial operations, regulatory affairs, quality and compliance for top tier Life Sciences organizations, including: Pfizer, Takeda, Allergan, Wyeth, AmerisourceBergen, Alcon Labs, Eisai, Forest Labs, Quintiles, Hospital Corporation of America, Merck, McKesson, Millennium, Novartis, Gilead, and Johnson & Johnson among others.
Register for this complimentary webinar below: |
As life science business environments are increasingly externalized and regulations are requiring more transparency, managing quality in a global and outsourced ecosystem has become extremely challenging. Regulators consider contractors an “extension of the manufacturer’s own facility” and expect a company’s supplier network to perform as an extension of the quality system. Leading companies are asking difficult questions:
- Are our suppliers and contract organizations putting our product quality at risk?
- Do our systems easily support quality initiatives across the new value-chain?
Organizations must shift their focus to transparency, providing a “single source of truth” for all parties to improve collaboration and simplify complex processes between internal and external partners.
Join us on March 30th for a FREE webinar that will show you how innovative life science companies have addressed the challenges of increasingly externalized operations.
You will learn:
- Why recent regulatory trends are putting current manufacturing and supply chain processes at risk
- How to improve visibility and management of quality across your supply chain
- How one company implemented a “single source of truth” in just four weeks
- Which strategies adopted by leading life science companies have led to increased quality in a global and outsourced environment
- How to give appropriate people access to the right data every time, from everywhere
- Why cloud can help improve supplier visibility and how to make the shift from paper to data
- What are the global regulatory trends and how to prepare your organization: Case for Quality, ISPE and Quality Metrics, FDASIA, EudraLex requirements for outsourced activities, Remote Audits (e-Inspections)
- How to make compliance your baseline and quality your goal
If you are looking to enhance visibility, collaboration and product quality across your increasingly externalized business, register today to learn about the next generation quality system and hear how other life science companies have addressed the challenge.
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