In the face of aggressive audits by regulatory agencies, life sciences companies continue to face unprecedented compliance challenges in ensuring data integrity. Such audits are unlikely to abate anytime soon. On the contrary, the agencies are hiring very highly literate computer experts to audit and aggressively pursue data integrity issues during audits. In the past four years, highly visible audits and investigations coupled with aggressive prosecution have resulted in significant financial judgments against even the most leading life sciences companies. Consequently, companies can no longer ignore the heightened challenges of ensuring data integrity in their enterprise. Business expediency requires them to train their personnel in understanding data integrity so that they can effortlessly identify and remediate potential data integrity problems before the auditors do so.
This interactive two-day workshop planned by WCS provides attendees the opportunity to interact with a Data Integrity Subject Matter Expert. Filled with numerous case studies from companies across the world, this workshop provides participants with the knowledge, approaches and techniques to effectively establish, monitor, control and assure the integrity of paper based and electronic data. It is designed for novices as well as experienced personnel from QA, IT, manufacturing, laboratory, regulatory and validation groups. It should also be of special interest to mid-level as well as senior level management.
Addressed will be data integrity case studies, inspection approaches and 483s and warning letters. Take back to your work, samples of Data Integrity related SOPs such as corporate wide Data Integrity policy, data integrity risk management, data integrity validation etc.
Areas Covered
· What is Data integrity
· Data Life Cycle design and controls
· Attributes of Data Integrity and how they map to predicate rules
· How do you know you have a Data Integrity problem in your company
· Elements of a Data Integrity Assurance program
· Roles and responsibilities of different groups in ensuring data integrity
· What data integrity SOPs do auditors expect to see during audits and should their contents be
· Validating Data Integrity
Who will Benefit
Pharmaceutical industry / Medical device industry / Healthcare industry personnel
Developers of software for use in Life Sciences industry
Validation service providers, IT service providers
Manufacturing personnel, Manufacturing Automation system vendors and system integrators
Regulatory Affairs group, Quality Unit
Laboratory personnel
Users of Cloud
Clinical Trial Sponsors
Learning Objectives
What are the recent regulatory changes for Data Integrity
What should be the management structure for DI accountability
What are the documentation requirements for Data integrity
What factors to consider before establishing a DI plan
How does CFR 21 Part 11 requirements translate to data integrity requirements
What are the success factors for a DI program
How is DI validated.
This interactive two-day workshop planned by WCS provides attendees the opportunity to interact with a Data Integrity Subject Matter Expert. Filled with numerous case studies from companies across the world, this workshop provides participants with the knowledge, approaches and techniques to effectively establish, monitor, control and assure the integrity of paper based and electronic data. It is designed for novices as well as experienced personnel from QA, IT, manufacturing, laboratory, regulatory and validation groups. It should also be of special interest to mid-level as well as senior level management.
Addressed will be data integrity case studies, inspection approaches and 483s and warning letters. Take back to your work, samples of Data Integrity related SOPs such as corporate wide Data Integrity policy, data integrity risk management, data integrity validation etc.
Areas Covered
· What is Data integrity
· Data Life Cycle design and controls
· Attributes of Data Integrity and how they map to predicate rules
· How do you know you have a Data Integrity problem in your company
· Elements of a Data Integrity Assurance program
· Roles and responsibilities of different groups in ensuring data integrity
· What data integrity SOPs do auditors expect to see during audits and should their contents be
· Validating Data Integrity
Who will Benefit
Pharmaceutical industry / Medical device industry / Healthcare industry personnel
Developers of software for use in Life Sciences industry
Validation service providers, IT service providers
Manufacturing personnel, Manufacturing Automation system vendors and system integrators
Regulatory Affairs group, Quality Unit
Laboratory personnel
Users of Cloud
Clinical Trial Sponsors
Learning Objectives
What are the recent regulatory changes for Data Integrity
What should be the management structure for DI accountability
What are the documentation requirements for Data integrity
What factors to consider before establishing a DI plan
How does CFR 21 Part 11 requirements translate to data integrity requirements
What are the success factors for a DI program
How is DI validated.
