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!!
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.
This virtual 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.
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.
Why you should attend
This virtual 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.
Agenda
- Data Integrity Framework
- Quality Risk Management
- Data Life Cycle
- Data Integrity Management
- Auditing & Audit Trails
- Data Integrity for Electronic Records/Electronic Signatures (ERES)
Speaker
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.
Who Should Attend
- 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
