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FDAnews Announces — Data Integrity Problems on the Rise: How to Implement the 5 Leading Solutions Webinar, March 31, 2016
  • USA - English


News provided by

FDANEWS

Mar 04, 2016, 13:15 ET

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FDAnews
FDAnews

Falls Church, VA (PRWEB) March 04, 2016 -- Data Integrity Problems on the Rise:
How to Implement the 5 Leading Solutions
March 31, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/dataintegrityproblems    
Data integrity issues have become a common — and ever increasing — problem over the last few years.

Uncovering data integrity issues within company 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 Glen Potvin of Quintiles Consulting. Glen has been in countless manufacturing facilities domestically and internationally and has seen firsthand the efforts to cover up data problems. And more importantly he has 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
o Improving corporate culture
o Developing clear and visible leadership
o Creating scorecards for measuring performance management
o Recruitment and retention strategies for employees that support good data management
o Risk based oversight and building effective training and development programs

BONUS — Attendees will receive:
• Case studies
• Sample templates for leading remediation solutions/methodologies
• Cultural assessment tips
• Audit checklist/questions
• Recommended list of procedures to help ensure good data integrity

Meet the Presenter:
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.

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

Webinar Details:
Data Integrity Problems on the Rise:
How to Implement the 5 Leading Solutions
March 31, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/dataintegrityproblems    

Tuition:
$287 per site

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

Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]

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