Baltimore Events

Validation of Computer Systems for Production and Quality and Software Embedded Medical Devices (NTZ)

Thursday

Sep 21, 2017 – 9:00 AM - 6:00 PM

890 Elkridge Landing Road
Linthicum Heights, MD 21090 Map

More Info

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

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



David R. Dills
Global Regulatory Affairs & Compliance Consultant

David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company's commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ's Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.



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$1,270 – $3,860

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