Outcomes you can take back to your team
A clear framework for evaluating where AI automation fits in your QMS
You will walk away knowing which QA processes, such as CAPA or complaints, are the best candidates for automation, and which still need human judgment.
A checklist for spotting when generic AI tools are a compliance risk
Practical criteria you can use to evaluate any AI tool your team is considering, before it creates an audit liability.
A real reference example to bring into your next quality or leadership meeting
A concrete, working demo you saw firsthand, not a theoretical pitch, that you can use to start the automation conversation internally.
The confidence to be the one who introduces this to your organization
You will leave able to explain, demo, and defend the idea of agentic AI in QA to skeptical colleagues or leadership, not just describe it secondhand.
Whether you own full QA responsibility or a specific area such as CAPA, Complaint Handling and Post-Market Surveillance, or Audits and Inspections, this session gives you a practical way to identify where AI fits, what to automate first, and how to introduce it with the right human oversight and governance.
Agenda
45 minutes, straight to what matters
Who Should Attend
Built for MedTech quality leaders
Quality and Compliance Leadership
- Quality Assurance
- Quality Operations
- QMS
- Quality Compliance
- Quality Systems
- Quality Engineering
Quality Processes You Own
- Design Controls and Risk Management
- Documentation and Records Management
- CAPA and Nonconformance Management
- Audits and Inspections
- Verification and Validation
- Complaint Handling and Post-Market Surveillance
Quality and regulatory professional focused on ISO 13485 compliance, QMS implementation, and audit ready medical device processes. Abarna works daily in the QA processes this session automates, from CAPA and nonconformance through documentation, records, and audit preparation, and brings QMS expertise that reaches beyond device QA. She will lead the session and run the Q&A.
- 10 years in quality assurance and testing across healthcare and insurance systems
- Test planning and execution across functional, regression, integration and end to end testing
- Works daily in QA documentation and defect workflows in tools such as HP ALM and JIRA