Validation of Computer Systems for Production and Quality and Software Embedded Medical Devices Seminar

Global Compliance Seminars

Understand Verification and Validation, differences and how they work together, Develop a "Working Definition" of V&V, Qualification, and related terms, Discuss recent regulatory expectations, Software Verification & Validation requirements of the FDA and ISO.

Course Description

Course "Validation of Computer Systems for Production and Quality and Software Embedded Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Why should you attend:

Understand Verification and Validation, differences and how they work together
Develop a "Working Definition" of V&V, Qualification, and related terms
Discuss recent regulatory expectations
Software Verification & Validation requirements of the FDA and ISO.
The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
Device and Manufacturing software requirements for V & V
How to determine & demonstrate an appropriate V & V strategy
How to determine & handle software for different Levels of Concern
What V&V is required for 3rd Party software-custom and Off-the-shelf
Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
What to look for during software vendor audits.
V & V documentation and level of detail required for device submissions.
How to document a "risk-based" rationale, and use it in a resource-constrained environment
Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
Generate Master and Individual Validation Plans
Learn the key elements of a Product V&V protocol and expectations with the Summary Report
Develop Process and/or Production/Test Equipment V&V Files/Protocols
Sample sizes and their justification
Learn the key elements of Software V&V expected by the FDA and how to document appropriately and adequately
QMS Electronic Records and Electronic Signatures per 21 CFR 11
Regulatory Requirements for Software Validation and Benefits
Quality System Regulation vs Pre-Market Submissions
Software requirements in specifications
Verification and Validation process
IQ/OQ/PQ in software V&V and next steps for compliance
Software development as part of system Design
Software life cycle verification
Software validation after a change
Validation of Off-the-Shelf Software and Automated Equipment
What is Process Validation
What are FDA and international requirements for Process Validation
Process Validation & Equipment Qualification
Examples of successful Process Validation activities
Where and how does software validation integrate into the Validation Plan
Recent examples of FDA Warning Letter cites and other enforcement actions for non-compliant V&V findings...what went wrong
Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
Review and discuss pain points, challenges and solutions
Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends
Prepare for Regulatory Inspections, including FDA and Operate in a State of Readiness

Who will benefit:

This seminar will provide an overview and in-depth snapshot of the process for managing V&V activities affecting product, process, equipment and the QMS. Company employees responsible for new product development, regulatory submissions, initiating/overseeing company-wide V&V planning, using a risk-justified approach and responsible for some of the areas identified herein, certainly will benefit. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the V&V process with product, process, software and impact on the QMS from start to finish, with key emphasis on regulatory compliance and governance, including:

Regulatory Affairs Management
Regulatory Affairs Specialist
Auditors
Compliance
Quality Assurance Management
Engineering/Technical Services
Operations/Manufacturing
Consultants
Quality Assurance or Quality Control Professionals
IT/IS
R&D
Production Management
Manufacturing Engineers
Process Engineers
Software Engineers
Validation Engineers
Project Managers
Hardware and software vendors, sales and marketing

Agenda:

Day 1 Schedule

Introductions and Overview
Device Concepts, Software Requirements
Software Designs and Implementation Activities
Software Testing
Non-Device Validation
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
Requirements Validation
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

Recap of Day 1
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

Debrief/Adjourn

Recap of topics and key discussion points and take away message
FAQs and latest trends with industry and regulators

Instructors Profile:

David R. Dills

Regulatory Affairs & Compliance Consultant,

David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

More Seminar Information

Global Compliance Panel
Summary	Understand Verification and Validation, differences and how they work together, Develop a "Working Definition" of V&V, Qualification, and related terms, Discuss recent regulatory expectations, Software Verification & Validation requirements of the FDA and ISO.
Delivery Method	Seminar
Who Should Attend	• Regulatory Affairs Management • Regulatory Affairs Specialist • Auditors • Compliance • Quality Assurance Management • Engineering/Technical Services • Operations/Manufacturing • Consultants • Quality Assurance or Quality Control Professionals • IT/IS • R&D • Production Management • Manufacturing Engineers • Process Engineers • Software Engineers • Validation Engineers • Project Managers • Hardware and software vendors, sales and marketing