FDAnews Announces — Managing Quality in a Global and Outsourced Ecosystem Webinar, March 30, 2016

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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 FDAnews on March 30, 2016 for a free webinar that will show how innovative life science companies have addressed the challenges of increasingly externalized operations.

Managing Quality in a Global and Outsourced Ecosystem
Free FDAnews Webinar
March 30, 2016 — 1:30 p.m. – 2:30 p.m. ET
http://www.fdanews.com/qualityecosystem    

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” (21 CFR 200.10) and expect a company’s supplier network to perform as an extension of the quality system. Leading companies are asking difficult questions:

  •     Are suppliers and contract organizations putting product quality at risk?
  •     Do the 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 FDAnews on March 30 for a free webinar that will show how innovative life science companies have addressed the challenges of increasingly externalized operations.

Attendees 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 the 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: Case for Quality, ISPE and Quality Metrics, FDASIA, EudraLex requirements for outsourced activities, Remote Audits (e-Inspections)
  •     How to make compliance the baseline and quality the goal

Companies looking to enhance visibility, collaboration and product quality across their increasingly externalized business should register today to learn about the next generation quality system and hear how other life science companies have addressed the challenge.

Meet the Instructor:
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.

Who Will Benefit:

  •     Auditors
  •     Compliance officers
  •     Consultants/service providers
  •     Data management and statistics personnel
  •     Executive management
  •     General/corporate counsel
  •     Investigators
  •     Managers
  •     Manufacturing directors and supervisors
  •     Pharmaceutical and cGMP auditors
  •     QA/QC personnel
  •     Regulatory/legislative affairs professionals
  •     Risk management specialists
  •     Strategic planning and business development staff

Webinar Details:
Managing Quality in a Global and Outsourced Ecosystem
Free FDAnews Webinar
March 30, 2016 — 1:30 p.m. – 2:30 p.m. ET
http://www.fdanews.com/qualityecosystem    

Easy Ways to Register:
Online:     http://www.fdanews.com/qualityecosystem
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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