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A Paradigm Shift for Pharmaceutical Manufacturers: Ready to Use Quality and Compliance Solutions



Now Available On Demand! Learn how new technologies and deployment methodologies are replacing traditional lengthy, costly, and complex QMS implementations. Hear how best-in-class organizations are ditching their paper-based, homegrown, and legacy QMS solutions for ready-to-use quality and compliance solutions.

Register Free: http://www.pharmexec.com/pe_w/paradigm

Event Overview:

New technologies and deployment methodologies are replacing the more traditional paper-based QMS systems. These technologies offer advantages over legacy and paper-based QMS solutions because they are easier and more cost effective to implement, and have built-in internal controls to ensure quality and compliance. But even when using commercial-off-the shelf applications, companies still must be familiar with the principals, industry standards, and regulations that apply to all systems to ensure that the product is properly validated in accordance with FDA requirements.

Register now to hear an interactive session that covers a situation analysis of quality and compliance today, with a look ahead at how new technologies are changing the QMS landscape.

Key Learning Objectives:
Attendees will learn:

  • What key advantages pre-configured, ready to use QMS can provide to pharma manufacturers
  • What key requirements pharma manufacturers must be compliant with when implementing an electronic-based QMS
  • How it is possible to break down silos and improve quality by using comprehensive ready-to-use solutions that are properly validated

Who Should Attend:

  • Quality Executives
  • Regulatory Executives
  • IT Executives
  • Compliance Executives
  • Supply Chain Executives


Mickey Landkof
GM and VP, Sales
Dot Compliance

Mickey is the General Manager and VP of sales for Dot Compliance, an innovative QMS solution provider. With over 20 years of professional experience in the worlds of business, compliance, and quality management technology, Mickey joined Dot Compliance after working at Veeva Systems, Sparta Systems, and 123Compliance. He is passionate about working with customers on their transformational quality systems initiatives and can be found speaking at conferences around the world, discussing the ever-changing landscape of quality and compliance.

Cynthia Schnedar
Principal of Regulatory Compliance
Greenleaf Health

Cynthia Schnedar, Principal of Regulatory Compliance at Greenleaf Health, provides strategic advice to clients in the life sciences industry. She was formerly Director of the Office of Compliance for FDA CDER, where she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety.

Cynthia previously served at the Department of Justice (DOJ) as Acting Inspector General and in other leadership positions focused on compliance and enforcement issues. Cynthia also served as a prosecutor and a civil trial attorney for DOJ. Cynthia clerked for a judge on the U.S. Court of Appeals for the Ninth Circuit and worked as a television reporter for local stations in New Mexico and Texas. Cynthia earned a B.A. with Distinction from the University of New Mexico and a J.D. with Honors from the University of Texas School of Law.

*The views presented in this webcast are Ms. Schnedar’s own and not her company’s nor an endorsement of Dot Compliance or its products.

Register Free: http://www.pharmexec.com/pe_w/paradigm

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