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Sponsored Webcast: Building Compliance with an Electronic Quality Management System (On-Demand)

1.5 RAC Credits Member: $0 NonMember: $25
Sponsored Webcast: Building Compliance with an Electronic Quality Management System (On-Demand)

This is an On-demand recording from March 2022.


Ensuring data integrity and patient safety has never been more challenging given the complex industry business models that have evolved over the last decade. Risk-based, fit for purpose approaches have become increasingly popular within operational functions. Novel operational solutions are being implemented across the industry, often before quality management systems and/or functions are established. This has led many leaders to inadvertently make risk-based decisions in a vacuum filled with myths and misunderstandings about the requirements, activities, and value associated with quality management system regulatory requirements.

Building a compliant, practical, and efficient quality system is foundational for a pharmaceutical company as well as the vendor companies that operate on their behalf. Like any foundation, the weaker it is and the longer corrections go unaddressed, the higher the risk to long term stability. Now that technology can dramatically improve efficiencies throughout the drug development and product life cycle; why do the same professionals who would never consider implementing a paper Trail Master File or an adverse event case processing and reporting system believe it’s too early for an electronic quality management system? This is happening due to inaccurate and misinformed risk/benefit decisions.

Sign up to attend this live broadcast and learn why it’s never too early to implement an electronic quality system. The program will discuss common myths driving leadership decisions related to quality management and assurance and paving the way for logic to prevail. You’ll to gain into clarity, compliance and how to build a stronger organizational foundation.

Learning Objectives

After this program, participants will:

  • Understand the value and efficiency early implementation of an electronic quality management system provides
  • Have clarity on the myths and realities surrounding quality management systems and the logical role they play in successful drug development and commercialization strategies
  • Know how to avoid unexpected compliance and financial costs by making fully informed risk/benefit decisions starting today
  • Be able to begin implementing actionable strategies for building (or strengthening) an organizational foundation that can withstand the twists, turns, and regulatory expectations inherent in our industry

Who Should Attend?

  • Leadership of all life sciences organizations (executive to manager)
  • Quality professionals
  • Regulatory professionals
  • Compliance managers
  • Risk management professionals

Pricing Amounts & Deadlines

Free

Instructors:

Nancy Singer

Penelope Przekop, MSQA, RQAP-GCP
CEO. PDC Pharma Strategy

Penelope Przekop is a corporate quality management expert, founder and CEO of PDC Pharma Strategy, and serves as the chief compliance officer for Engrail Therapeutics. Throughout her 30+ year career, she has worked with numerous Fortune 100 pharmaceutical companies, including Pfizer, Merck, Lilly and Glaxo Smith Kline, and has held leadership positions at Novartis, Covance, Wyeth and Johnson & Johnson. Przekop is the author of Six Sigma for Business Excellence and her latest book, 5-Star Career: Define and Build Yours Using the Science of Quality Management, which was released in November 2021. She earned an MS in quality systems engineering from Kennesaw State University, and she is a graduate of the Smith College Program for Women’s Leadership and the Rutgers University Senior Leadership Program for Professional Women.

Susan Rolih

Kelly Stanton
Director of Quality, Qualio

Kelly Stanton is the director of quality at Qualio, helping customers and the company adhere to the evolving regulatory landscape. She serves as an advisor to more than 20 medical device and pharmaceutical companies and leads a team of talented industry-experienced quality professionals, who work daily with companies in regulated industries. Stanton brings more than 20 years of experience in both the pharmaceutical and medical device industries to the world of small start-ups and scalable quality system implementations. Having been an implementer, administrator and user of many different eQMS tools on the market, she has built several quality systems.


Contact Us

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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