Lean Validation: Elevate Your Processes with Computer Software Assurance and Digitalization
In today’s rapidly evolving landscape, where the FDA’s new guidance and cutting-edge digital platforms, including generative AI, are shaping the future, it’s paramount to reassess your organization’s practices. Now is the time to modernize your processes for optimal efficiency and compliance.
Unlock a World of Possibilities with Over 15+ Tutorials Covering Today’s Top Challenges
Computer Software Assurance Implementation:
- Conduct a Comprehensive Gap Analysis and Transition Seamlessly to CSA
- Dive into Scripted and Unscripted Testing, Assessing Requirements and Criticality
- Navigate Post-Transition Challenges: Training Programs, Change Control, Continuous Monitoring
Digitalization Implementation and Validation:
- Embrace Human-Centered Design: The Soft Skills Essential for Successful Digitalization
- Explore the Journey to a Paperless Environment: Case Studies and Best Practices
- Harness the Power of Digital Threads and Ensure Data Integrity Governance
- Innovative Approaches: Leveraging ChatGPT & Generative AI in Validation
- Delve into Real-World Case Studies: Implementing Machine Learning and Digital Twins
Topic: Harmonizing Equipment Qualification – Modular CSA Approach
Date and Time: 26-06-2024, 3:40 – 4:20 PM EST
Panelists:
🎤 Khaled Moussally: EVP Corporate Development and Operations
🎤 Ray Murphy: Software Quality Engineering Fellow, Boston Scientific
🎤 Margaret Hindley: Director CSA/IT, Taiho Oncology
🎤 Katelyn Staub-Zamperini: Senior Operations Officer ORA, FDA
Topic: Case Study: Implementing CSA
Date and Time: 27-06-2024, 8:20 – 9:20 AM EST
Speakers:
🎤 Margaret Hindley: Director CSA/IT, Taiho Oncology
🎤 Monica Manepalli: Sr.CSV/CSA Consultant, Compliance Group
Topic: Going Paperless: Digitalization Implementation & Validation – A Case Study
Date and Time: 27-06-2024, 12:00- 12:40 PM EST
Speakers:
🎤 Khaled Moussally: EVP Corporate Development and Operations
🎤 Margaret Hindley: Director CSA/IT, Taiho Oncology