Medical Device Process Validation training for Injection Molding Processes – Basics
What will You Learn:
Kickstart your process validation journey with this interactive, hands-on course tailored for beginners. Learn to design validation processes that meet FDA, MDR, and ISO 13485 standards, ensuring patient safety, process reliability, and compliance. Through practical, real-world assignments—like drafting a high-level validation plan—you’ll explore the three key stages: Process Design, Process Qualification, and Continued Process Verification. Walk away with skills you can apply immediately, guided by expert trainers who make it engaging and effective.
Target Audience
Quality Engineers, Process Engineers, Project Managers, Automation Engineers , Process Technicians, Team Leaders
Key Learning Objectives:
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- Design a validation process aligned with FDA, MDR, and ISO 13485.
- Understand why validation ensures patient safety, reliability, and compliance.
- Get hands-on with the stages: Process Design, Qualification, and Verification.
Course Details
- Duration: 2 Days Onsite, 8 Hours Each
- Format: In-Person, Hands-On, Small Group Setting (Max 12 Participants)
- Prerequisites: Basic Knowledge of Excel and MS Word (or Equivalent)
- Certification Note : First Step Toward Becoming a Certified Process Validation Specialist
Agenda:
- Day 1: Validation Foundations and Process Design
- Morning (4 Hours):
- Intro to process validation—why it matters (patient safety, reliability, compliance) and overview of FDA, MDR, and ISO 13485 requirements (1.5 hr).
- Basics of the Process Design stage with real-world examples (1.5 hr).
- Quiz: Quick validation basics check (15 min), followed by group discussion (30 min).
- Afternoon (4 Hours):
- Hands-on workshop: Start drafting a simple validation plan—define objectives and scope (2.5 hr).
- Quiz: Process Design recap (15 min), followed by group feedback and discussion (1 hr).
- Morning (4 Hours):
- Day 2: Process Qualification and Continued Verification
- Morning (4 Hours):
- Explore Process Qualification—key steps and checks (1.5 hr).
- Intro to Continued Process Verification—monitoring basics (1.5 hr).
- Quiz: Qualification and Verification essentials (15 min), followed by group discussion (30 min).
- Afternoon (4 Hours):
- Practical assignment: Complete the high-level validation plan (add qualification and verification steps) (2.5 hr).
- Quiz: Full process recap (15 min), followed by plan review, discussion, and takeaways (1 hr).
- Morning (4 Hours):
What You’ll Gain
- Understand the process validation framework and why it’s critical for patient safety, reliability, and compliance.
- Confidently explain the purpose of Process Design, Qualification, and Continued Verification stages.
- Follow validation experts’ discussions and apply basic concepts like FDA, MDR, and ISO 13485 requirements.
- Recognize why process validation thrives with a multidisciplinary team—and how to contribute.
Join the course
- Ready to master process validation basics? Sign up for our 2-day onsite course (max 12 participants) and start your path to becoming a Certified Process Validation Specialist. Schedule on request—secure your spot today!
- Price: €2,400
- Scheduling: On Request – Contact Us to Book
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