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Medical Device Production and QMS Software Validation Training

If you’re using software to automate a process that is required by FDA, there is a good chance you’ll be required by FDA to validate that software to demonstrate that it accurately, reliably, and consistently meets the requirements for its intended use. ISO 13485 has similar requirements. In this course, you will learn how and when to effectively implement a non-product software validation program for medical devices that meets FDA and ISO requirements. We will also cover the role of risk management in non-product validation.

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Brief Overview of This Class on Non-Product Software Validation

SkillsLab Class ?

Class Content

In-Depth

Class Duration

4 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEU)

1.6

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 2 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming FDA and ISO 13485 Non-Product Software Validation Training Classes

SkillsLab $2995

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
NPS VIRTUAL DELIVERY (Eastern Time) 21 May 2024 24 May 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
NPS VIRTUAL DELIVERY (Eastern time - PM) 03 Sep 2024 06 Sep 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
NPS VIRTUAL DELIVERY (Eastern time - PM) 02 Dec 2024 05 Dec 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Training Class on FDA Non-Product Software Validation

Non-product software is used across the full life cycle of a medical device and includes software used in the manufacturing process (e.g., software embedded in machine tools and statistical process control software); in design and development processes (e.g., CAD, CAM); software used to automate any part of the quality process (e.g., complaint-handling software); and software related to electronic records and signatures for documents required by regulation. In this class you'll learn how to meet the requirements for identifying, validating, and managing the life cycle of non-product software found in quality management systems compliant to ISO 13485:2016 and 21 CFR 820.70.

Course Overview
SkillsLab Class

Overview of Non-Product Software (NPS) Validation

  • Non-product software in the QMS
  • Distinguishing between product software and NPS
  • The NPS life cycle and the validation process
  • Requirements and standards for NPS validation
  • Categories and types of NPS that require validation
  • Gathering information about NPS
Exercise! Identify NPS
Exercise! NPS Inventory List

Risk Assessment of NPS

  • Purpose of risk assessment for NPS validation
  • Risk assessment and risk control steps
Exercise! Assign Risk Levels to NPS Systems

Validation Process for NPS

  • NPS product and process review
  • Life-cycle approach for NPS and its deployment in the QMS
  • Managing the NPS validation project
  • Supplier management
  • Configuration management
  • Validating low-risk NPS
  • Spreadsheet validation
Exercise! Determine Level of Effort for NPS Validation

Planning NPS Validation

  • Validation of medium- and high-risk NPS
  • Planning NPS validation
  • Relationship of NPS validation planning to the master validation plan (MVP)
  • The system design and description document (SDDD)
  • The requirements specification document (RSD)
Exercise! Determining Needed Planning
Exercise! RSD Documentation

Testing and Test Protocols

  • Configuration testing: installation qualification (IQ)
  • Functional testing: operational qualification (OQ)
  • Requirement testing: performance qualification (PQ)
  • Establishing testing protocols, test cases, and test procedures
  • Role of the traceability matrix in verification and validation testing
  • The validation summary report (VSR)
Exercise! Develop Test Cases and Test Procedures
Exercise! Traceability Matrix

NPS Life-Cycle Maintenance

  • NPS maintenance and operation through its life cycle
  • Evaluating changes to NPS and their impact on validation testing
  • Completing the NPS life cycle: significant update or retirement
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Distinguish non-product software (NPS) from product software

Describe NPS validation requirements found in ISO 13485:2016 and 21 CFR 820.70

Describe the overall life cycle of NPS software in the quality management system (QMS)

Develop and/or evaluate a validation process for NPS

Determine effort of NPS validation based on a risk assessment

Plan, define, and implement validation of NPS for deployment of NPS

Describe the use of system design and requirements in NPS validation

Document test protocols, testing, verification activities, and validation activities

Describe validation needs for low-, medium-, and high-risk NPS

Describe how to document NPS validation results

Explain maintenance, changes, and retirement of NPS

Who Should Attend

Who Should Attend

Quality engineers, validation engineers, computer software validation (CSV) personnel, IT personnel, test engineers, personnel in supplier quality, production/manufacturing/operations quality, developers and users of non-product software, and project managers in these areas. Participants are expected to have a working knowledge of ISO 13485:2016 and process validation. 

  • Quality Engineers
  • Validation Engineers
  • CSV Personnel
  • IT Personnel
  • NPS Developers/Users

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