Live Webinar on
Cleanroom & HEPA Filter Testing & Certification: An Owners Guide
Date & Time:
Tuesday, November 01, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Charles V. Gyecsek
Price : $245.00 (for one participant)
Charles V. Gyecsek
This seminar concentrates on identifying and discussing testing and
President, MIJ Enterprises,
certification requirements associated with cleanrooms.
The key benefits of this course are:
Charles Gyecsek is formerly of
Hoffman LaRoche where he worked
primarily in Validation, Microbiology,
In-dept understanding of industry standards, processes, and
criteria for testing cleanrooms and HEPA filters.
Quality, and Operations. During his
career Charles set-up and managed
Achieve satisfactory inspections more easily.
one of the largest GMP cleanroom
Higher assurance of new medical product approvals.
facilities in the US, encompassing
more than 200 rooms in 3 separate
Reduce rates of batch rework and rejections.
facilities. Charles' extensive
Avoid product recalls.
experience involves plant start-up,
cleanroom design and renovation,
quality system auditing, regulatory
Why should you attend:
submission writing, microbiology,
Regulatory agencies expect manufacturers to periodically
equipment and cleaning qualification,
demonstrate that cleanrooms and controlled environments perform
utility validation, water system
design and validation, aseptic
according to their designspecifications.
processing, risk management, and
regulatory inspections and
Areas Covered in the Session:
Define cleanroom filters and equipment.
Suggest a Topic
Identify regulatory expectations and industry standards.
Define the tests, frequencies, and methods.
Your Necessity is our Priority
Define the expectations for testing equipment.
Identify who does the testing.
Identify requirements for documentation/logs/labeling.
Define criteria and how to interpret results.
Click here to register for this webinar
Who Will Benefit:
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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