Computer Systems Validation & Software Assurance University
December 5 – 7, 2023 | San Diego, California
With FDA’s heightened focus on Software Assurance and Data Integrity – Computer Systems Validation has taken on a new movement initiated by regulatory authorities. In fact, FDA has taken the lead with a proposed guidance on Computer Software Assurance and is asking firms to rethink their approach. With that said, the challenges remain high in our rapidly changing environment. In fact, inspectors continue to find serious findings such as – interrupted, missing, deleted and lost data; inadequate records for risk analysis; failure to exercise appropriate controls; failure to validate computer software; failure to establish validation procedures; manipulation and deletion of audit trails; and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures.
Top Reasons to Attend
- Overview FDA’s CSA proposed guidance and hear about lessons learned from the FISCA team
- Understand the CSV movement and the difference from CSV traditional practice
- Conduct a gap assessment of current programs and identify critical areas to align with CSA
- Benchmark with case studies on how other firms aligned their legacy programs with CSA
- Reduce documentation with automated systems that comply with the upcoming guidance
- Understand what the guidance means by critical thinking, see examples of where to apply, and teach personnel how to use this concept
- Understand the interrelationship of CSA, Part 11, and Data Integrity Compliance
- Modernize software validation by using risk-based testing based on Good Engineering Practice
- Understand how, where and what to conduct a successful software risk assessment
- Change management – Drive adoption through collaboration and effective training programs
- Discovers successful strategies to implement processes enterprise-wide
- Audit vendors for quality and determine risk