Inspection Intelligence: Develop a Data–Driven Approach - Webinar CD/Transcript

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Inspection Intelligence: Develop a Data–Driven Approach

To be inspection ready you must understand both the internal and external data affecting your products — and analyze and act on the data.

Are you inspection-ready?

Expert Armin Torres — Principal Software Consultant at Qualified Data Systems — discusses how to make sure that your data — which has come from multiple sources — is internally consistent across the full data set and with your company metrics and KPIs.

After attending this 90-minute session you will know the answers to some of your most puzzling Quality Metrics Guidance questions including:

  • How to make raw data available using the least burdensome approach
  • How to control the cost of manual or automated data collection, review,  and aggregation
  • How to develop a process for digital data extraction, cleansing, integration, and validation prior to reporting
  • How to make available training and resources for data analysis, interpretation, and visualization
  • How to implement tools for analytical processing
  • How to manage additional software validation requirements
  • How to deliver timely management reporting
  • How to make data actionable in order to operationalize a data-driven culture

Use your own data to show investigators what you did, when you did it and most importantly why you did it.

  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Data management and statistics personnel
  • Engineering and design controls teams
  • Executive management
  • Regulatory affairs
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors

Armin Torres, Principal/Senior Software Consultant, Qualified Data Systems
Armin has more than 20 years of management and engineering experience in the areas of quality assurance manufacturing, technical support, statistics, validation, in-vitro diagnostics quality and regulatory compliance, and software development within the pharmaceutical and medical device industries. Armin is also a Certified Software Quality Engineer (CQE) and certified instructor of Statistical Process Control and Design of Experiments.