The renewed interest in data integrity raises questions regarding what is data integrity and how to assess it. Much discussion of quality metrics has ensued regarding how to respond to the FDA’s guidance and its elements. It is also critical to visualize and analyze data to solve problems and improve processes. Three critical aspects of data analysis are the context for the problem and business objectives, the visualization of the data and the analytical modeling of the data. The critical question is how to go about this in a systematic and effective manner.
In this workshop each of these data issues and questions are addressed. Emphasis is on providing practical solutions that can be implemented promptly. It is pointed out that these initiatives are inter-related and should not be treated separately. It is shown how a data-centered culture can be built to implement and sustain these initiatives over time.
- Develop awareness and understanding regarding role and importance of data and FDA Guidances regarding data-based approaches and methods
- Understand the importance of data pedigree and how to assess it
- Data Integrity – What is it, why is it important and how to assess it
- How to identify and overcome the challenges and make effective use of quality metrics
- How to use concepts, methods and tools that enable the management and execution of data-rich projects
- How to build a data-based culture that enables the integration of these inter-related data challenges enabling the initiation and sustaining of these initiatives over time.
- In all case guiding principles, tips and traps are presented and discussed.
Who Should Attend:
- Quality Department Management and Staff
- Research and Development Departments Management and Staff
- Engineering Departments Management and Staff
- Manufacturing Departments Management and Staff
- Production Departments Management and Staff
- Regulatory Affairs Departments Management and Staff
- Lab Testing Personnel
- Biologists and Microbiologists
- Supply Chain Departments Management and Staff
- Process Improvement Professionals
- Product Development Personnel
- Finance Departments
- Everyone who collects, analyzes and presents data to solve problems and make improvement
DAY 1 (8.30 AM – 4.30 PM):
Registration Process – (8:30 AM – 9 AM)
- Introductions, Agenda and Participant Expectations
- Today’s realities
- Importance and Role of Data – Big and Small
- FDA Expectations Regarding Data
- QbD, PAT, Process Validation
- Quality Metrics
- Data Integrity
- Data Integrity – What, Why and How
- Importance of Data Pedigree
- Quality Metrics – What, Why and How
- Building a Data-Centered Culture Part I
- Summary and Evaluation of Day 1
DAY 2 (8.30 AM – 4.30 PM):
- Review and Discussion of Day 1
- Introduction to Analytics
- Analytics Building Blocks
- Assessing Data Pedigree
- Developing Models – Getting Started
- Model Verification – Prediction Accuracy over Time
- Success Factors for Analytical Studies
- Building a Data – Centered Culture Part II
- What We’ve Learned
- Workshop Evaluation
Dr. Ronald D. Snee
Founder and President of Snee Associates, LLC
Ron also serves as Adjunct Professor in the Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering Program. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceuticals.
He received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University.
Ron in an Honorary Member of the American Society for Quality and has been awarded the ASQ’s Shewhart, Grant and Distinguished Service Medals. Other awards and honors include the American Statistical Association’s Deming Lecture, W. J. Dixon Statistical Consulting Excellence and Gerald J. Hahn Quality and Productivity Achievement Awards. He is a frequent speaker and has published six books and more than 300 papers in the fields of performance improvement, quality, management, and statistics.
He is a past recipient of the Institute of Validation’s Speaker of the Year Award.
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- Once the payment is completed, you will be receiving a Form to fill up the Delegates Information
- An electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date.
- Please bring the respective passes to the event venue.
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- Once we receive the check, you will be receiving a Form to fill up the Delegates Information
- After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.
DoubleTree by Hilton Boston Logan Airport Chelsea
Boston, MA, USA | April 4 – 5, 2019