Course "Validation of Computer Systems for Production and Quality and Software Embedded Medical Devices" has been pre-approved by

RAPSas eligible for up to12credits towards a participant's RAC recertification upon full completion.

Overview:

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

Speaker

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 forSoftware Quality Professionaland the Institute of Validation Technology (IVT), publisher of theJournal of GXP Compliance and Journal of Validation Technologyand on the Readers' Board forMedical Device & Diagnostic IndustryandMedical Product Manufacturing Newsand 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.

Location: Baltimore, MDDate: September 21st & 22th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: The DoubleTree Baltimore-BWI Airport890 Elkridge Landing Road - Linthicum, MD 21090 USA

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 16, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

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