Simplifying Global Compliance
Data Integrity Problems on the Rise - Webinar CD/Transcript
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Data Integrity Problems on the Rise: Confronting Data Integrity Issues Within Your Operations or Your Partners/Suppliers
Data integrity issues have become a common — and ever increasing — problem over the last few years.
Uncovering data integrity issues within your 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 presentation 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’re 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 presentation, you 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
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
Who Will Benefit
This course will be of 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
From the following companies:
- Drug companies
- Biotech companies
- Biologic companies
- Contract manufacturers
- Contract laboratories
- Suppliers
- Law firms
Meet Your 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. Marie has authored published articles and white papers and has also shared her industry expertise as a speaker at various professional conferences. During her consulting career, Marie has received recognition for delivering brilliant client service and developing employees. She earned a master’s in Career and Technical Education from Virginia Polytechnic Institute and State University. In 2014, Marie was selected as Quintiles’ 2014 HBA Rising Star.
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. Glen holds a Bachelor of Science degree in Pharmacy from the University of Connecticut, and an MBA degree from the Whittemore School of Business at the University of New Hampshire.