Production Validation For Medical Devices

🚑 Production Validation Training in Medical Devices - IQ, OQ, PQ 🏥

Course Headline: Master the Critical Steps of Production Validation in Medical Devices with Our Comprehensive IQ, OQ, PQ Training!

Introduction to Validation in Medical Devices

• What is Validation? Discover the fundamental concept of validation and its critical role in ensuring medical devices meet regulatory standards and patient safety requirements.

Terms and Definitions

• Dive into the technical jargon and understand key terms such as IQ (Installation Qualification), OQ (Operation Qualification), and PQ (Performance Qualification).

Standards, Regulations, and Legislations

• Grasp the complex landscape of related standards, regulations, and legislations including 93/42 EC Medical Device Directives, 745/2017 Medical Device Regulatory Directives, and EN ISO 13485:2016.

Course Scope

• Learn the comprehensive scope of production validation processes and how they align with regulatory requirements to ensure medical devices are safe and effective.

Responsibility

• Understand your role and the roles of various stakeholders in the production validation process, from design to distribution.

Validation Planning/Protocol

• Gain insights into creating a robust validation plan and protocol that is both compliant and tailored to your specific medical device.

IQ (Installation) Validation Process(es)

• Explore the steps necessary to ensure the manufacturing equipment and facilities are properly installed, calibrated, and ready for use in producing medical devices.

OQ (Operation) VALIDATION

• Learn how to validate that your medical device production operations are performed consistently according to specifications and design intent.

PQ (Performance) VERIFICATION

• Discover the methods to confirm that the final product meets its intended use, performance requirements, and user expectations.

Detection of Inappropriate Situations/Inappropriate Data

• Identify and address potential issues or data inconsistencies that could compromise the validity of your production process.

Evaluation of Validation

• Evaluate the effectiveness of your validation activities to ensure continuous improvement in product quality and safety.

Process Traceability

• Implement effective traceability systems to track and document each step of the manufacturing process, ensuring accountability and compliance.

Re-validation

• Understand when and how to re-validate processes to maintain the integrity and efficacy of your medical devices throughout their lifecycle.

Confirming Validation

• Confirm that all validation activities have been successfully completed, ensuring every step from design to production aligns with the validation protocol.

Validation Protocol Examples

• Receive practical examples and real-world case studies to apply validation principles to various scenarios in medical device manufacturing.

In this academic education training, we delve into the intricacies of the production process as mandated by the 93/42 EC Medical Device Directives, 745/2017 Medical Device Regulatory Directives, and EN ISO 13485:2016 Quality Management System Standards. All processes, from the acceptability of raw materials to the final product, are thoroughly discussed with concrete examples for clear understanding.

• Product Realization (7.XX) covers all aspects from planning the realization of the product to control, cleaning, identification, and traceability.
• Design and Development (7.3) emphasizes the importance of incorporating validation considerations early in the design process.
• Control of Production and Service Provision (7.5) outlines the critical steps to ensure each production batch adheres to the established standards, from control measures to product storage.

Standard Items Explained

Throughout the course, we'll also explore standard items such as Cleaning of the Product, Identification, Traceability, and more, ensuring you have a comprehensive understanding of each component in the production validation process.

Join us for an in-depth learning experience that will equip you with the knowledge and skills to confidently navigate the world of production validation in medical devices, ensuring compliance, safety, and quality excellence. Enroll now to take your first step towards mastering IQ, OQ, PQ, and beyond! 🎓🏫✨