Clean Room Control, Validation & Monitoring for Medical Devices

Clean Room Control is a mandatory regulatory requirement for Terminally Sterilized Medical Device manufacturers. The FDA–QSR the EU MDR/IVDR and ISO 13485 include explicit requirements for Clean Room Control. Some manufacturing activities of Terminally Sterilized medical devices must be performed in a controlled environment (clean room) T controlled Environment needs to be initially qualified and continuously monitored.

During this course the topics of Clean Room Control, Validation & Monitoring will detailed including effective methods and tools.

Content:

Regulatory Requirements
Definitions
Classification (Non-viable & Viable)
Documentation- SOPs
Initial Qualification (Validation)
Ongoing Monitoring (periodic)
- Physical
- Non-viable Particulate
- Microbial (EN 141710)
Cleaning & Maintenance
Personnel Gowning
Re- Qualification

Understanding the Regulatory Requirements
Understanding the classification of Clean Rooms
Providing an overall strategy for Clean Room Validation & Monitoring Providing methods and tools for Design Control including templates

Medical Device Industry professionals from disciplines such as: Quality Assurance, Regulatory, Project / Product Management, Engineering, Design & Development, Operations.

Registration Form

Course title: Clean Room Control, Validation & Monitoring for Medical Devices

Information

Live online training via Zoom;
View presenter and interact with attendees;
Certificate will be sent after completing the course;
Before attending the course, you will be sent the meeting ID, passcode and link for the course.

Registration Fee

Early Registration: $700 (Until 08 May 2023)

Regular Registration: $780 (Until 28 Jun 2024)

Late Registration: $900 (Until 08 Jul 2024)

$900

Per person (Tax included)

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