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Validation of Computer Systems for Production and Quality and Software Embedded Medical Devices
Sep 21, 2017 - 09:00 AM - Sep 22, 06:00 PM
Link to Website
TBD Baltimore, MD, USA 21201,
Phone: 1 929 900 1853
Why should you attend:
Who will benefit:
Day 1 Schedule
Device Concepts, Software Requirements
Software Designs and Implementation Activities
Software development life cycle (SDLC), including examples of commonly used SDLCs
Software V&V documentation
Electronic Records and Electronic Signatures (Part 11)
Software Embedded Medical Device Testing and Validation and Regulatory Expectations and Requirements
Software Standard Operating Procedures related to V&V
Software Quality Assurance Planning
Software Test Strategies & Methodologies
Verification and validation, including regulatory definitions, regulatory intent, and common tasks
Regulatory framework and the relationship of various sources of regulatory requirements
Key regulations, standards, and guidance documents
Integrating risk management processes
Design control and software validation guidance
Testing-level strategies (unit, integration, system, user)
Methods development and documentation requirements, plus test protocol content
Configuration management, change management, and maintenance strategies
Documentation requirements for premarket submissions
Processes, procedures, and outputs for typical phases (e.g., examples, roles, relationships)
Defects and issues management
Design and quality planning, including traceability and reviews
Lessons learned from case studies and warning letters
Design software validation plans that build confidence in the software and comply with regulatory requirements for device, commercial off-the-shelf, and Quality System software
Use risk management to focus validation activities to minimize risk
Streamline elements of the Quality System for cost-efficient software development and validation
Day 2 Schedule
Regulatory Guidance and Regulations and Additional Resources
Select appropriate lifecycle models and synchronize validation activities for all types of software
Write unambiguous, testable requirements
Integrate best development engineering practices to support validation efforts
Organize test designs, test cases, and test procedures that effectively cover requirements being verified, and that provide opportunities for review and management of the process
Regulatory and Compliance Overview/FDA Snapshot on V&V for Manufacturers/Master Validation Planning
FDA's approach and Risk Management Tools with ISO 14971, ICH and other Guidance/Standards - Product, Process Equipment V&V Product/Device V&V
Software V&V and where and how does software validation integrate into the Validation Plan
Quality Management System/21 CFR Part 11 expectations and requirements
Avoid or Minimize Compliance Concerns and Issues: Q&A/FAQs and review of company documentation
Review of group activity and hands-on examples and activities show real-world implementation of useful governing principles, tools and templates and the most recent enforcement actions for trending, compliance and governance
FAQs and latest trends with industry and regulators
David R. Dills
BUSINESS & MANAGEMENT CONFERENCES,
Keywords: fun, audience, design , development , Engineering , environment, Fun , hardware, industry , lear
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