FDAnews Announces — Data Integrity Problems on the Rise: Confronting Data Integrity Issues Within Your Operations or Your Partners/Suppliers Webinar, May 19, 2015

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Data integrity issues have become a common and ever increasing problem over the last few years. This webinar, presented by Marie McDonald and Glen Potvin of Quintiles Consulting, describes a proven approach to uncover and address data integrity issues within companies and their partner networks.

Data Integrity Problems on the Rise:
Confronting Data Integrity Issues Within Your Operations or Your Partners/Suppliers
**FDAnews Webinar**
May 19, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/DataIntegrity

Data integrity issues have become a common and ever increasing problem over the last few years.
Uncovering data integrity issues within manufacturing operations or partner networks can be challenging, and once data integrity issues come to light, remediating them can be even more difficult.
Drug and device companies need a system for assessing the way their staff or partners create, record, process and maintain data.

This presentation describes a proven approach to uncover and address data integrity issues within companies and their partner networks.

This webinar will be presented by Marie McDonald and Glen Potvin of Quintiles Consulting. Marie and Glen have been in countless manufacturing facilities domestically and internationally. They’ve seen firsthand efforts to cover up data problems. And more importantly they’ve fixed the problems and developed systems and influenced corporate cultures to assure they don’t happen again.

In this one-of-a-kind 90-minute webinar, attendees will learn:

  • Recent case histories highlighting recent data integrity lapses
  • How to establish a “right to win mentality” through proactive steps and surveillance activities
  • Proven tools and techniques used to uncover data integrity issues
  • How to characterize the scale and scope of issues using methodologies like the Maturity Curve Model
  • How to design and deploy the remediation strategy
  • Best practices for tailoring solutions to the problems identified — One size does not fit all
  • How to implement the 5 leading solutions for data integrity issues
  • Improving corporate culture
  • Developing clear and visible leadership
  • Creating scorecards for measuring performance management
  • Recruitment and retention strategies for employees that support good data management
  • Risk based oversight and building effective training and development programs

Meet the Presenters:
Marie McDonald, Vice President – Quintiles Consulting — Marie R. McDonald has dedicated the last 15 years of her professional life to improving her clients’ probability of success. As a consulting business partner for biopharmaceutical and medical device companies, Marie has worked on consulting engagements that span strategy development, program and project planning, process design, quality systems improvement, training, and change management. As a Vice President within Quintiles Consulting, Marie is responsible for account management, engagement delivery, expanding Quintiles’ consulting practice, developing industry thought leadership, and professionally developing her teams.

Glen Potvin, Senior Director – Quintiles Consulting — Glen is an accomplished leader of successful business improvement programs among leading pharma and medical device companies including: Johnson & Johnson, Eli Lilly, Pfizer/Wyeth, Boehringer Ingelheim, Genzyme, Terumo, and Merck/Schering Plough. Glen has a valuable combination of pharmacy degree, plant management, corporate leadership and global management consulting expertise across disciplines including: compliance, quality, manufacturing, clinical drug development, drug safety, R&D, regulatory affairs and labeling. He has more than 20 years of experience in delivering results through teamwork, structured analysis, creative problem solving, strategy development, and focused project management.

Who Will Benefit:

  •     Auditors
  •     Clinical project specialists
  •     Clinical research associates
  •     Compliance officers
  •     Consultants/service providers
  •     Data management and statistics personnel
  •     Engineering and design controls teams
  •     Executive management
  •     General/corporate counsel
  •     Investigators
  •     Managers
  •     Manufacturing directors and supervisors
  •     Personnel new to the industry

Conference Details:
Data Integrity Problems on the Rise:
Confronting Data Integrity Issues Within Your Operations or Your Partners/Suppliers
**FDAnews Webinar**
May 19, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/DataIntegrity

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/DataIntegrity
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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