Cleanroom & HEPA Filter Testing & Certification: An Owners Guide - Webinar by GlobalCompliancePanel

Overview: This webinar concentrates on identifying and discussing testing and certification requirements associated with cleanrooms.

The key benefits of this course are:

• In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters
• Achieve satisfactory inspections more easily
• Higher assurance of new medical product approvals
• Minimize nonconformances
• Reduce rates of batch rework and rejections
• Avoid product recalls

Why you should attend: Regulatory agencies expect manufacturers to periodically demonstrate that cleanrooms and controlled environments perform according to their design specifications. In addition, periodic testing confirms the efficacy of maintenance and process controls. It is the responsibility of the Cleanroom owner to maximize the value of cleanroom testing to ensure optimal performance.

Many Cleanroom owners rely on external test/certification services to recommend and perform the testing for their cleanrooms. This does not, however, relieve the Cleanroom owner of their responsibility to understand, interpret, and act on the results of the testing.

Areas Covered In the Seminar:

• Define cleanroom filters and equipment
• Identify regulatory expectations and industry standards
• Define the tests, frequencies, and methods
• Define the expectations for testing equipment
• Identify who does the testing
• Identify requirements for documentation/logs/labeling
• Define criteria and how to interpret results

Who will benefit:

• QA personnel
• Regulatory personnel
• Manufacturing Operators
• Maintenance Personnel
• Consultants
• Operations managers
• Microbiologists
• Validation Personnel
• Training departments