Course Description
The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company. However, and most importantly, data integrity issues can lead to potential patient harm!!
Defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as "the extent which all data are complete, consistent and accurate throughout the data lifecycle", data integrity is increasingly the focus of regulatory agencies round the world. Companies must now ensure that they are appropriately addressing data integrity and data governance. This includes organizational, procedural and technical controls that must be considered as part of an overarching data governance system. In addition, the effort and resources committed to data integrity must be commensurate with the role it plays in assuring product quality.
To ensure Data Integrity, a GxP regulated company needs to abide by principles, current regulations and industry best practices on the expectations for the management GxP regulated records and data. These principles, regulations and best practices, ensure that data is complete, consistent, accurate, secure and available throughout the record life cycle. This approach is intended to encourage innovation and technological advances while avoiding unacceptable risk to product quality, patient safety and public health.
Key implementation considerations for a corporate data integrity program, include development of a high-level strategy, identifying and gaining executive sponsorship, focusing on management accountability, implementing tools for knowledge sharing and developing and providing the appropriate levels of training. An effective data integrity program includes addressing of behavioral factors and drives a strategy that focuses on prevention, detection, response and continuous improvement.
The Seminar:
This Seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical, biological, medical devices, cosmetics, food and any other industry where data integrity is important. It provides a method for managing risk to record and data integrity. Learning Objectives for the seminar include:
Data Integrity Requirements
Critical Areas of Regulatory Focus and Concern
Key Concepts
A Framework for Data Governance and Human Factors
A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction
How to Apply Risk Management to Data Integrity
Course Audience:
- VP of IT
- Director of IT
- Quality Managers
- Project Managers (for CSV / IT)
- Validation Specialists
- Database Administrators
- System Administrators
- Directors / Senior Directors of Discovery
- Directors / Senior Directors of Development
- Directors / Senior Directors of Commercialization
- Document Managers
- Training Managers
- Regulators
- Vendors
- Suppliers
- Outsource Service Providers
________________________________________
Industries:
- Pharmaceuticals
- Biotech
- Medical Device
- Radiological Health
- Blood Products
- Companion Animals
- Food
- Cosmetics
- Tobacco
- Academia
Agenda
Day 1 Schedule
Lecture 1:
Introduction and Background
Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
Regulatory Focus
Data Integrity Requirements
Lecture 2:
Data Governance Framework
Elements of the Data Governance Framework
Human Factors in Data Integrity
Data Integrity Maturity Model
Lecture 3:
Quality Risk Management
Process Risk Management
Quality Risk Managemet
Product and Process Context
Lecture 4:
Data Life Cycle
Data Creation
Data Processing
Data Review, Reporting and Use
Data Retention & Retrieval
Data Destruction
Integrating Data Integrity into Existing Records Management Process
Day 2 Schedule
Lecture 5:
Data Integrity Management
Corporate Data Integrity Program
Data Integrity Maturity Model
Human Factors
Inspection Readiness
Lecture 6:
Auditing & Audit Trails
Data Audit Trail
Audit Trail Review
Data Auditing
Periodic Review
Lecture 7:
Data Integrity for Electronic Records / Electronic Signatures (ERES)
User Requirements
Process Mapping & Interfaces
Controls for Electronic Records / Electronic Signatures
Data Integrity for Spreadsheets & End-User Applications
Data Integrity for IT Infrastructure
Lecture 8:
Data Conversions
Retention, Archiving & Migration
Paper Records & Hybrid Situations
Converting Electronic to Alternative Format or Alternative Format Hybrids
Quiz: Jeopardy!!!!
Data Integrity
Audience
• VP of IT
• Director of IT
• Quality Managers
• Project Managers (for CSV / IT)
• Validation Specialists
• Database Administrators
• System Administrators
• Directors / Senior Directors of Discovery
• Directors / Senior Directors of Development
• Directors / Senior Directors of Commercialization
• Document Managers
• Training Managers
• Regulators
• Vendors
• Suppliers
• Outsource Service Providers
________________________________________
Industries:
• Pharmaceuticals
• Biotech
• Medical Device
• Radiological Health
• Blood Products
• Companion Animals
• Food
• Cosmetics
• Tobacco
• Academia