Equipment, Systems, Analytical
Process and Method Validation
Description: A Validation Engineer is responsible for planning, implementing and monitoring the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. They measure and analyze the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced. There is currently a high demand for trained validation engineers. As a result, salaries are highly competitive. Validation describes the process of creating an evidence trail to show that an action, process or system leads to a consistent and reproducible result. This ‘result’ is typically either taking a measurement or assessing product quality. Validation is a central part of the manufacturing process within the pharmaceutical and medical device industries. The products made must be exactly the same every time and are tested at the end of the production process to ensure that this is the case, but final end product testing isn’t enough. In addition, the processes, systems, and equipment that lead to their manufacture are closely scrutinized too. This establishes that they meet predetermined specifications and always produce the same result.
Each step in the manufacturing process is subject to validation, to ensure that the end products are safe and effective, every time. Validation tasks are carried out during all stages of a product lifecycle – from research and development, through to manufacture and distribution. Validation is not only important in the establishment of manufacturing protocols, but it is also used to make that changes to systems, equipment or processes within an established manufacturing system, do not change the outcome or product.
Training and Course Structure
This program provides fundamental to Advanced understanding of designing, managing, and maintaining a scientifically sound validation program. The curriculum focuses on core Validation function and their underlying principles.
Course Content / Topics Covered for Validation Engineer Training:
Types of validation
21 CFR Part 11
System Development Life Cycle
User Requirement Specifications
Functional Requirement Specifications
Installation Qualification Protocol
Operational Qualification Protocol
Performance Qualification Protocol
Requirement Traceability Matrix
Validation Summary Report
Test Summary Report
System Release Report
Types of Testing
Test Task Report
Root Cause Analysis
Corrective and Preventive Actions
Standard Operating Procedures
Good Manufacturing Practices
Good Laboratory Practices
Good Clinical Practices
Medical Devices concepts and Predicted rules
Enterprise Document Management System (EDMS)
Enterprise Content Management System (ECMS)
Laboratory Information Management System (LIMS)
Change Control Management System (CCMS)
Adverse Event Reporting System (AERS)
Drug Development Life Cycle Regulatory Requirements for Cleaning
Job Responsibilities of Validation Engineer professionals in general are:
• Design validation study features, such as sampling, testing, or analytical methodologies.
• Direct validation activities, such as protocol creation or testing.
• Draw samples of raw materials, or intermediate and finished products for validation testing.
• Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
• Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
• Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
• Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
• Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
• Identify deviations from established product or process standards and provide recommendations for resolving deviations.
• Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
• Procure or devise automated lab validation test stations or other test fixtures and equipment.
• Resolve testing problems by modifying testing methods or revising test objectives and standards.
• Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
• Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
• Communicate with regulatory agencies regarding compliance documentation or validation results.
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Maintain validation test equipment.
• Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
• Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
• Plan or conduct validation testing of alternative energy products, such as synthetic jet fuels or energy storage systems, such as fuel cells.
• Validate or characterize sustainable or environmentally friendly products, using electronic testing platforms.
May 16, 2021