subject: Cleanroom & HEPA Filter Testing & Certification: An Owners Guide - Webinar by GlobalCompliancePanel [print this page] 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
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
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