INTRODUCTION FOR SOFTWARE VALIDATION FOR MEDICAL DEVICE
This course equips participants with the essential knowledge and skills to conduct software validation for medical devices, ensuring compliance with regulatory requirements.
LEARNING OBJECTIVE
By the end of this training, participants will:
- Gain a solid understanding of Software Validation, Computer Systems Validation, and regulatory requirements for Electronic Records and Electronic Signatures.
- Learn about key regulatory bodies, including the FDA and European authorities, with hands-on exercises on implementing compliance requirements.
- Understand how validation applies to computer hardware and software systems used in Manufacturing, Quality Assurance, Regulatory Compliance, and Process Control.
- Explore the latest FDA regulations, including 21 CFR Part 11, and the application of Quality Risk Management in Software Validation.
KEY BENEFITS
Participants will be able to:
- Apply principles of Software and Computer Systems Validation.
- Implement the Validation Life Cycle approach.
- Use Quality Risk Management techniques.
- Develop essential validation documents (e.g., URS, FDS, VMP, IQ, OQ, PQ).
- Comply with 21 CFR Part 11 requirements for Electronic Signatures and Records.
WHO SHOULD ATTEND
This course is ideal for:
- Quality Managers, Engineers, and Technicians involved in medical device development and manufacturing.
- Regulatory Affairs and Quality Assurance professionals ensuring FDA compliance.
- Process Development and Manufacturing teams responsible for validation activities.
COURSE CONTENT
Day 1:
- Introduction
- Software Validation Laws & Regulations (ISO 13485, FDA, MDR)
- Electronic Records & Signatures Compliance
- Software Validation Life Cycle Overview
- Risk-Based Approach to Validation & Verification
- Validation Requirements Using GAMP 5 and the V-Model
- Q&A
Day 2:
- Software Validation in Quality Management Systems
- Validation of Software in Production & Manufacturing
- Establishing Software Validation Protocols & Reporting
- Mock Validation Exercise
- Q&A & Final Discussion
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