Data Integrity, Quality Metrics and Data Analytics


2-Day In-Person Seminar (Code – SEM9016)

Data Integrity, Quality Metrics and Data Analytics


   


  Dr. Ronald D. Snee

    Boston, MA, USA

 


    April 4 – 5, 2019

1 DELEGATE

3 DELEGATES

5 DELEGATES

$ 1300

(Save $ 300) 🛈

$ 1170 / Delegate

(Save $ 1290) 🛈

$ 1040 / Delegate

(Save $ 2800) 🛈

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Why You Should AttendAgendaSpeakerPricingVenue
The use of data has been part of the FDA’s guidance and regulations for many years. Recent uses include Quality by Design, Process Analytical Technology, Process Validation, Data Integrity and Quality Metrics. Advances in information technology have greatly increased the opportunity to use data to develop and improve processes including the benefits of “Big Data”.

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.


Learning Objectives:

 

  • 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


Ronald D. Snee, PhD, is Founder and President of Snee Associates, LLC. He provides guidance to senior executives in their pursuit of improved business performance using Lean Six Sigma, Quality by Design (QbD), and other data-based improvement approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Human Genome Sciences, and Kraft Foods.

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.

 

PRICING OPTIONS
For Single Delegate – $ 1300 (Save $ 300 on Early Bird Discount)
Regular Price – $ 1600

Get 10% Discount on Group of 3 Delegates – $ 1170 / Delegate on Early Bird Offer (Save $ 1290)
Get 20% Discount on Group of 5 Delegates – $ 1040 / Delegate on Early Bird Offer (Save $ 2800)

EARLY BIRD OFFERS CLOSES ON MARCH 21, 2019
 
 
 
Early bird seats are limited and based on first-come, first-serve..(Only 5 Remaining)
 

For discounts on multiple registrations, contact customer care at +1-416-915-4458

 
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  • 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


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