2-day Workshop: Current Regulatory Thinking on Data Integrity in 2020 | Philadelphia, USA - May 11-12, 2020

DUBLIN, Feb. 21, 2020 /PRNewswire/ -- The "Current Regulatory Thinking on Data Integrity in 2020" conference has been added to ResearchAndMarkets.com's offering.

This intermediate-level workshop focuses on emerging data integrity concepts and audit focus areas. Attending this workshop will enable attendees to not only become familiar with data integrity fundamentals and practices but to also effortlessly identify and remediate potential data integrity issues before auditors do.

Data integrity continues to be one of the topmost concerns of regulators worldwide. With regulatory agencies actively hiring computer-savvy personnel, we can only expect increased and rigorous audits of data integrity.

Addressed will be case studies, inspection approaches, trends in the issuance of data integrity 483s and warning letters in the recent past. Take back to your work, samples of Data Integrity related directives and SOPs such as Data Integrity Policy, Maintenance of Electronic Records directive and many more that are required to establish a data integrity infrastructure in your company.

This intermediate-level workshop is for experienced personnel from QA, IT, manufacturing, regulatory and validation groups. It addresses data integrity issues in all life science industry sectors where data is required to fulfill regulatory requirements. These sectors include medical devices, biologics manufacturing, quality control laboratories, clinical trials, blood establishments, compounding pharmacies, etc.

Objectives

• Understand existing USFDA and EU GMP regulations and guidance for data integrity
• Learn requirements for a Data Governance program and Data Integrity Assurance plan
• Learn how to link data lifecycle to process-centric data integrity business processes
• How to continually monitor and improve Data Integrity impacting business processes
• Data Life Cycle design and controls
• Elements of a Data Integrity Assurance program
• Some advanced Data Integrity topics include
• Roles and responsibilities of different groups in ensuring data integrity
• hat data integrity SOPs do auditors expect to see during audits
• What is the Data Integrity triad
• How to validate Data Integrity impacting business processes
• Data Integrity Maturity Model
• Developing critical thinking skills
• Data Integrity Audit trends

• Executive management
• Regulatory affairs
• Quality assurance/quality control
• Legal and compliance officers
• Clinical research directors
• Consultants/service providers
• CAPA specialists
• Compliance information managers
• GMP compliance officers
• GMP training managers
• Heads of internal audits
• QA documentation managers
• QA/QC managers and directors
• Quality systems managers
• Systems analysts
• Training personnel

Agenda:

Day 1

Module 1 - Setting the scene: importance of DI

• Compendium on DI
• What are the principles of DI
• Navigating the maze of DI guidance - which guidance to use for what
• Summary of DI observations to date

Break

Module 2 - Why Data Integrity issues occur

• What are the top 5 misconceptions of DI
• What are the 5 ways to detect DI issues
• 5 ways to prevent DI issues to occur
• What is the Controls Triad for DI
• Mitigating the single most DI factor: Human behavior and their drivers

Lunch Break

Group exercise: Assessing a system for DI

• Using a checklist for different types of assessments
• Group suggests solutions for real world case studies detected during field audits

Break

Module 3 - Addressing specific DI issues

• Raw Data management - why significant, applicable predicate rule, DI guidance
• Laboratory Controls - what is it, its predicate rule and Table of Contents of its SOP
• Audit Trail Review - DI significance and Table of Contents of its SOP
• Implementing a Data Integrity remediation Plan - Identifying DI gaps using Gemba walks along with their remediation
• Special considerations for Data Integrity Risk assessment using DI Life cycle and Process Flow charts

Day 2

Module 4 - Recipe for DI success: a process-centric approach

• What is a process-centric approach
• What is Cultural excellence and what are its 6 dimensions
• Understanding deviant human behaviors and how to address them proactively

Break

Module 5 - Data Integrity issues in the cloud

• Regulatory compliance requirements for Cloud use
• Sharing DI responsibilities for Cloud use
• Data Integrity audit of GxP supplier of Cloud services using SOC 2 process
• Validation of DI for Cloud use
• Applying FDA's Case for Quality for Cloud use

Lunch Break

Module 6 - Implementing Data Integration remediation at an existing facility

• Setting up for success: Critical factors to consider for team formation
• GEMBA walk checklist
• Guidance on how to mitigate DI gaps in existing equipment/systems

Break

Module 7 - Data Integrity by Design and Pharma 4.0

• What is the digital manufacturing model
• Critical Role of IT in ensuring Data Integrity in Pharma 4.0
• Organization's essential Data Integrity Maturity elements for migrating to Pharma 4.0
  

For more information about this conference visit https://www.researchandmarkets.com/r/cdxyjc

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Research and Markets
Laura Wood, Senior Manager
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