Why Should You Attend:
Software design, development, implementation and use is under increased scrutiny by a `tougher` U.S. FDA. Software V&V issues are becomming a growing area of concern by regulatory agencies. Product production/test equipment, and even the QMS are heavily software/firmware driven in today's manufacturing. Part 11 and cybersecurity are often important considerations. A comprehensive, corporate wide plan is a necessity. Growing `cloud` issues add urgency to upgrade control. Software's complex logic pathways mandate resourse-intensive V&V activities, in a resource-constrained environment, demanding a risk-based approach. What are the best approaches for companies to take? How can tougher expectations be met? What V&V is necessary to minimize software failures? Use the FDA's own `model` to document all types of SW V&V. And use this model to add predictability to bring software V&V in under budget and within project timelines.Agenda
- Major areas of industry failure
- Tougher FDA Expectations/Requirements; Cybersecurity
- Roles of Verification and Validation
- An FDA `Model`
- A Typical Software V&V Protocol/Test Report; `Black` and `White` box
- A Brief Overview of 21 CFR Part 11, and its implementation
- Legacy, Hybrid, New and ER/ES Systems
- Expected Regulatory Deliverables
- Cybersecurity
Who Should Attend
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated device production software/firmware V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing `cloud` environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software produiction equipment and process validation projects. This information applies to personnel/companies in the Medical Device and some Combination fields. The employees who will benefit include:- Senior management
- Regulatory Affairs
- Quality Assurance/QAE
- Production
- Engineering, R&D, and software development and testing teams
- All personnel involved in a U.S. FDA-regulated environment. Especially those involved in new product development with products and productioin/test equipment that are software driven, companies with quality management/MRP/ERP systems moving toward `paperless` systems, or other regulated medical products/CGMP and ISO QMS activities.
