FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Although the concept was introduced in 2011, industry still struggles with the complex challenges of our rapidly change quality and technical environments…
Time, cost, morale, and company reputation are all affected by how well your firm masters the art of Quality Audits and FDA Inspections, and should be a high priority for all pharmaceutical and biotech companies…
To this day, Computer Systems Validation, Software Assurance and Data Integrity challenges remain high in our rapidly changing, highly regulated environment…
Process Validation & Continued Verification
March 24, 2021
10:00 AM – 5:00 PM EST
Virtual, United States
Audits and Inspections
March 25, 2021
10:15 AM – 5:00 PM EST
Virtual, United States
Time, cost, morale, and company reputation are all affected by how well your firm masters the art of Quality Audits and FDA Inspections, and should be a high priority for all pharmaceutical and biotech companies…
Computer Software Assurance & Systems Validation
April 7, 2021
10:00 AM – 5:00 PM EST
Virtual, United States
To this day, Computer Systems Validation, Software Assurance and Data Integrity challenges remain high in our rapidly changing, highly regulated environment…
Data Integrity Governance and Inspection Readiness
April 8, 2021
10:00 AM – 5:00 PM EST
Virtual, United States
The use of automated systems, artificial intelligence and digital technology has brought out new challenges with data integrity compliance…