validation of cleanroom
Validation Of The Cleanroom Course
Validation of Cleanrooms to EN ISO 14644 series
This is a one-day training course to provide all participants with a good appreciation of the EN ISO 14644 series requirements for sterile medical devices and their relationship with MDR and UK MDR 2002 compliance. The course includes direct case studies, interactive discussion, and practical work, providing extensive coverage of the requirements of the EN ISO 14644-1 to -5 standard; this covers classification, contamination control, validation, and monitoring of cleanrooms.
- Identify the links between UK MDR 2002/MDR and the requirements of the EN ISO 14644 series.
- Explain the definitions and important key terms used and concepts for core compliance.
- Understand how these standards ensure and maintain a low bioburden environment.
- Define the cleanroom classification and validation aspects.
- Recognise the methods used for monitoring and maintenance.
- Identify the main factors for cleanroom validation and reporting.
Learning Objectives / Course Learning Outcomes
At the end of the course, the participant will be able to;
Contents of the Course
- I. Introduction
- II. Classification of Cleanroom
- III. Control of Contamination
- IV. Metrology and Measurement Methods
- V. Cleanroom Configuration
- VI. Cleanroom Validation
- VII. Monitoring Procedures
- VIII. Cleanroom Maintenance
This course is suitable for:
- Managers and/or personnel for Regulatory and Quality Assurance
- Managers and/or personnel for Design and Development
- Quality Control and Microbiology personnel
Learning Methodology
Our training will be provided to participants using interactive and engaging learning techniques. Participants will engage in case studies, aspects of real-life application, and guided exercises that will reinforce theoretical and practical knowledge.
Courses are provided online or in-company (tailored specifically to your organisation’s operational requirements).
Costs
Online Course: £450 per person
- Student Discount: Special pricing is available. Contact admin@mdsspro.com for details
- On-Site (in company) Training: Customised to your organisation’s requirements, email admin@mdsspro.com
Prerequisites
Participants should have a basic understanding of:
- Microbiology
- Physics
- Quality Management Systems
Why You Should Take This Course?
Gain Practical Knowledge in Cleanroom Validation and Compliance
This course fills the gap between regulatory theory and its application in the real world. The course is delivered by experienced professionals with real-world cleanroom compliance and ISO 14644 experience and will leave you inspired to practically apply your experience in cleanroom management, contamination control, and validation.
Regardless of whether your role is in regulatory affairs, quality assurance, or design and production, this course will reinforce your technical knowledge and capability to comply. With an interactive mix of discussion, case studies and applied learning, MDSSPRO makes sure you leave with the skills to properly validate and maintain cleanroom environments.
Let's Build Compliance Confidence Together
Work with MDSSPRO to ensure your medical devices comply with the highest regulatory standards.From customised training to professional auditing, we are with you every step of the way to fully comply with the MDR.
