DATA INTEGRITY GOVERNANCE AND INSPECTION READINESS
Develop, Implement and Maintain a Compliant Program Enterprise-wide
April 8, 2021
10:00 AM – 5:00 PM EST
The use of automated systems, artificial intelligence and digital technology has brought out new challenges with data integrity compliance. Combining these issues with the impending release of FDA’s Computer Software Assurance, the time has never been greater to ensure your organization’s Data Integrity program is effective and continuously monitored for compliance. This virtual training illustrates the processes, programs and tools that will ensure your firm is inspection ready.
Top Reasons to Attend:
Understand the interrelationship with FDA’s Computer Software Assurance proposed guidance
Identify gaps and investigate root causes of lapses ‘s
Understand the impact of human performance – Transform the culture
Conduct a risk-based remediation
Implement a CAPA process – What to do when things go wrong
Manage corporate challenges and define clear roles and responsibilities
Learn how to effectively document risks
Learn compliant processes for legacy software applications
Implement process mapping to identify data integrity gaps
Use critical thinking for your approach to technology
Understand CSA’s applicability to Data Integrity
Audit your audit trails – Are we challenging status quo?
Overcome the top challenges of program implementation
Monitor controls through process monitoring
Prevent error with design, automation and procedure control
Personnel in the Following Environments Should Attend:
This event is also appropriate to business development and sales managers that offer innovative solutions for quality departments, validation departments, data collection and software platforms.