Industries: Medical Device

Medical Device Process Validation Training for Professionals

Course Director: Jonathan Lee

Course Fee: $2650.00 Regular Registration / $2450.00 Early Bird (30 Days in Advance)

Course Brochure: Medical Device Process Validation Training for Professionals

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

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. Also to be discussed is how to tackle process validation for medical device combination products.

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

Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course.

Why This Course Matters

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. Internationally, 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.

Newer products and processes pose additional challenges to organizations. New processes are more complex thereby making process validation more difficult. Using the tools developed in this course, participants will be able to methodically plan and conduct a process validation.

Who Should Attend

This three-day medical device validation training 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 Regulatory Affairs, Quality Assurance & Control, Auditing & Compliance Engineering, Process Development, Quality Engineering, Manufacturing Engineering, Design & Development Engineering, Documentation Control Specialists.

To maximize the peer learning opportunity, this medical device process validation course is recommended for those who may have a core level of understanding of Medical Devices, the Quality System Regulation (QSR) and/or ISO 13485, with some direct work experience.

This process validation training 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.

Course Agenda

First Day

1. 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

2. Implementing a Process Validation System

  • The Infrastructure
    • Records & Document Control
    • Roles and responsibilities
    • The process validation procedure
    • Equipment and facilities
    • Purchasing
  • 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
    • System validation priority – criticality & risk
    • The Validation Master Plan (VMP) and controlling the process
    • Audit Considerations

Second Day

Day One Review

3. Executing a Validation

  • The Process Validation Steps
    • Understanding the process to be validated
    • Identification of the critical equipment and parameters of the process
  • Mapping 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
  • Test Results and Data Analysis
    • Use of statistical tools in validation
    • Acceptance Sampling tables and rules
    • Averages, medians, mode and standard deviation
    • Process Capability and Cpk
    • Monitor process performance
    • T-tests, ANOVAs and F-tests
    • Data handling and analysis of data
  • Special case – ‘compound’ records
  • Group Exercise: Determine the tests, methods and criteria needed to validate a system used in production of a hypothetical Medical Device.

4. 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
  • Re-validation
    • 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

Third Day

Day One and Two Review

5. 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
    • Applicability
    • 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
  • Device software and the EU
  • Software and ISO 14971
  • Software and IEC 62304
  • Commercial off the Shelf (COTS) Software
  • FDA and “Level of Concern”
  • Role and importance of the traceability matrix
  • Incorporating Medical Device Software Verification & Validation (V&V) into a Quality System
  • 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.

6. Supplier Process Validations

  • Requirements of Suppliers and Purchasing Controls
    • Top level product risk & Supplier selection
    • Validation based on component/material criticality to the process
    • Role of Quality Agreements in Process Validation
    • Managing changes of process, sub-tier supplier or material changes
    • Incoming Inspection vs Validation of supplied components/materials
    • Use of Quality Audits of suppliers to ensure component/material integrity

7. Combination Products

  • Meeting Requirements of 21 CFR Part 820 and 21 CFR 210/211
    • Definition of a Combination Product
    • Regulation of a Combination Product
    • Validation of a Combination Product

8. Other types of Validations

  • Application of Validation Principles in Other Areas
    • Controlled Storage
    • Cleaning
    • Shipping
    • Shelf life
    • Reliability testing

9. Process Validation & Compliance

  • Methods for Evaluating Compliance
    • Internal audits & challenging validated processes
    • Non-conformities and Corrective Action-Preventive Action (CAPA)
    • Failure Mode Effects Analysis (FMEA) & Risk Assessment
    • Process Changes/Improvements

Learning Objectives

Objectives of this three day course are to provide an understanding of Medical Device process validation, explaining how, when, where and why to validate processes.

  • 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 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
    • Identify how process validations can integrate and overlap with LEAN principals.

Testimonials

"It was a great experience! Very useful! It covered everything I wanted to know about this topic." Dr. Peter B., Project Leader, Microdul AG
"This course challenged me and was better than courses I’ve taken with other training companies." Emma C., Process Product Engineer, MediSystems Europe
"Another great course! Really liked the instructor. He was pleasant and had a great sense of humor. He really knew his subject with many years of experience behind him. The course book was excellent - a great resource for us. The location was very nice - everyone was accommodating to us. The food provided was so wonderful. I am sure I gained 10 lbs. The whole experience was top class - from instructor to location. This has been a wonderful addition to my knowledge base for my job and reference library." Lynne F., Stability Project Coordinator, DePuy-Synthes
"The course was well thought out with a good level of detail. I found the clarification of verification vs. validation very useful." Mark G., Product Manager, Trelleborg
"Well prepared and clear. Examples used were most helpful." Pertrice W. Validation Manager, LSI Solutions
"The course was excellent. Unlike other courses, this one had many practical aspects which help to better understand the theory. I enjoyed the Case Studies and Group Practices." Lesvia D., Process Engineer, BBraun Medica
"In comparison to courses from other training providers this was the best by far." Mike F., Facilities Manager, Trelleborg
"The course notes are much more detailed that other courses I’ve taken and the instructor was very thorough and knowledgeable.." Shirlyn Q., Supplier Quality, Genentech
"I found the 'Process Validation for Medical Devices' course to be one of the best courses I have taken. All the information presented was on the money for what I was looking for in this course. I found the instructor to be a wealth of knowledge and wonderful in keeping the class engaged. This course is refreshing for me coming from medical devices to have a course tailored to medical devices and not pharma. Thank you for the knowledge." Michelle N., Sr. Clinical Scientist, bioMerieux
"Wow! Finally a course created for and focusing on the needs of the medical device industry. The course director brings a ton of experience and worldly knowledge and it showed. I particularly liked the inclusion of focus on validation master plans…not simply focusing only on IQ/OQ/PQ's. Well done. The hotel is very nice as a conference location." Robert P., Manufacturing Engineer, Abbott
"There was a lot of material covered. I was impressed with the way the instructor set the course up. IQ OQ PQ was first, followed by process validations, DOE's, FMEA's, software validations and why all these are required. The instructor made the class feel comfortable from day one and encouraged questions. I definitely have more confidence about the work I am doing." Matt C., Biomaterials Quality Engineer, Globus Medical
"The Course Director answered the questions of the group directly and did not make the answer more confusing than the question. This implied a willingness to 'take a stand' on a validation issue." Stephen C., Sr. Quality Engineer, Synthes
"The course was quite good and thorough. The scope and subject matter were directly related to my job." Jamie V., Manager, Chemistry Lab, Trelleborg
"Excellent course! I now have a much better understanding of what needs to be done, how much and how to do it. Thank you." Kathy D., QC Engineer, Medtronic