Process Validation for Medical Devices
Process Validation for Medical Devices
Course Director: Jackelyn Rodriguez
Course Cost | Course Location | Course Date
October 18-20, 2017 | Costa Rica
$1450.00 Regular Registration
Doubletree by Hilton Cariari San Jose-Costa Rica
San Antonio de Belén, Ciudad Cariari
November 8-10, 2017 | Amsterdam
$1450.00 Regular Registration / $1300.00 Early Bird (30 Days in Advance)
DoubleTree by Hilton Hotel Amsterdam - NDSM Wharf
Amsterdam, 1033 WB Netherlands
Aditional Course List: Click here
Workshop Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 1:00 on Day 3 (Breakfast & Lunch Included).
The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with the principals of process validation.
FDA regulators believe through careful design and validation of the process and appropriate process controls, a manufacturer can establish a "high degree of assurance" that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing. More recently, with the introduction of risk management to medical devices, it is important to correctly apply the principles of risk management when implementing and maintaining process validation activities.
Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety.
Issues to be covered include:
- Learn how poor validation procedures and practices can lead to regulatory actions from regulators.
- Assurance of product quality derived from a compliant validation program.
- Learn how to improve process system knowledge and understanding.
- Learn methods for developing process validations and best practices.
- Understand the scope of regulations governing process validation and identify gaps.
- Develop a plan to rectify existing validation plans, protocols and reports.
- Learn how to implement and deploy a master validation plan and review MVP examples.
- Learn how to validate software for PLC systems as well as off the shelf software.
Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course.
Who Should Attend
This two and a half-day course is targeted toward Medical Device professionals directly involved in meeting International and FDA's Quality System requirements specifically relating to Process Validation.
Typical attendees include: Professionals in Quality Assurance & Control, Auditing & Compliance Engineering, Process Development, Quality Engineering, Manufacturing Engineering, Design & Development Engineering, and Regulatory Affairs,.
This course provides attendees with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation (CFR 820), and the Quality System standard ISO 13485 while providing direction on how to implement an effective process validation program.
- Introduction to Process Validation
- Process Validation
- Terminology and what is Process Validation? What purpose does it serve?
- Understand the concepts of Process Validation and when it is necessary or preferred
- The importance of understanding the process and process variability
- Regulatory Perspective
- Process Validation compliance requirements
- Understand the perspectives of the FDA and International Regulatory entities
- Consequences of non-compliance or lack of Process Validation
- Review examples of FDA actions regarding Process Validation
- Process Validation Requirements and Elements
- Validation Master Plans & Site Validation Plans
- Evaluating the Requirements
- Identifying the Elements
- Risk Management’s role in Process Validation
- Equipment Installation, Operation and Performance Qualifications (IQ, OQ, PQ)
- Acceptance criteria, Validation Protocols and Reports
- Staffing and Training
Interactive exercise: Design Requirement Matrix - Participants will develop linkage between design control requirements to production processes.
Implementing a Process Validation System
- The Infrastructure.
- Records & Document Control.l
- Roles and responsibilities.
- The process validation procedure.
- Equipment and facilities.
- Purchasing and FATs.
- The High Level Steps.
- Process mapping.
- Assess the status of the existing processes & support systems.
- Gap analysis.
- Determine the tasks required to achieve compliance.
- Closing the gaps.
Risk Management & Content of Validation Master Plans
- Risk management and risk-based approaches & Process FMEA.
- Impact Assessment.
- System validation priority – criticality & risk.
- The Validation Master Plan (VMP) and controlling the process.
Interactive Exercise: Participants will generate will create/complete a process FMEA sheet for a specific process (the specific processes will be identified during the course) In Addition, participants will identify linkage to Impact Assessment (a tool to identify which areas of a process or equipment should be validated, driven by the impact & risk on the product/process).
Executing a Validation
- The Process Validation Steps.
- Understanding the process to be validated.
- Identification of the critical equipment and parameters of the process.
- Development of protocols.
- Special Case: Legacy products.
- Execution of validation protocols: Practical Considerations.
- Addressing Protocol Execution Problems.
- Managing test failures, deviation or discrepancies.
- Validation Protocol Design and Preparation.
- Establish protocol objectives.
- Establishing Acceptance Criteria.
- Determine the critical equipment and parameters of the process.
- Develop the validation protocol, ensuring critical parameters are assessed.
- Importance of ‘units of measure’ and measurement methods.
Interactive Exercise: Participants will write a IQ/OQ for a piece of equipment within a process (equipment based on previous exercise, instructor will also provide an example of an already completed one).
Test Results and Data Analysis
- Use of statistical tools in validation.
- Acceptance Sampling tables and rules.
- Process Capability and Cpk.
- Monitor process performance.
- Data handling and analysis of data.
- Process development.
- Design of Experiments.
- Importance of Validation Training.
- Using various statistical tools and methods.
- Characterization Studies.
- Multi-vari Analysis & CPK (Process Capability Studies).
- Design of Experiments (DOE).
- Validation Summary report.
- Project plans and their importance in validation.
- Protocol(s) and report(s).
Group Exercise: Determine the tests, methods and criteria needed to validate a system used in production of a hypothetical Medical Device.
The Validation Life Cycle
- Maintaining the Validated State
- Maintaining Equipment and Facilities
- Managing Equipment Changes
- Managing Materials or Processes Changes
- Determining when additional validation is required
- Use of Lead and Gold standards
- ‘State of Control’: Performance monitoring & charting
- Determining when it’s required
- Determine what needs to be re-validated
- Managing issues that may arise during re-validation
- Determining implications for the process and/or product
- Product Complaints and Product/Process Failures
- Importance of product Risk Assessment
- Determination of Process or Product failure
- Non-compliance & Complaints
- Evaluation to determine cause
- Determining if existing validation will require amendment or change
- Managing incremental product design changes
Software Validation & Compliance with 21 CFR Part 11
- Software systems
- Product and non-product software
- 21 CFR Part 11 Overview
- Purpose and Scope of Guidance
- Principles of Software Validation
- Software Lifecycle Activities
- How much validation evidence is needed?
- What to look for in an audit of a Part 11 Validation
- Commercial off the Shelf (COTS) Software
- Role and importance of the traceability matrix
Group Exercises: Implementation of software-based systems: Validation considerations
- Software used to control a medical device manufacturing process.
- Software used in a Quality System process.
- Participants will:
- Learn how satisfy FDA and International compliance requirements for process validation
- Learn the importance of, and steps for, completing compliant IQ, OQ, PQ
- Learn how to develop and execute validation protocols to meet requirements
- Learn how to develop Capability studies
- Learn how to validate software
- Learn how to ensure that systems remain in a validated state
- Understand when re-validation is required & the importance of documentation
- Develop an understanding of software validation and Part 11
Who Should Attend
Typical attendees include: Professionals in Quality Assurance & Control, Auditing & Compliance Engineering, Process Development, Quality Engineering, Manufacturing Engineering, Design & Development Engineering, and Regulatory Affairs. This course provides attendees with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation (CFR 820), and the Quality System standard ISO 13485 while providing direction on how to implement an effective process validation program.
For more information, click HERE
All of course can be delivered on-site and can be fully customizable
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