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
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
Charles V. Gyecsek President, MIJ Enterprises, Inc.
This seminar concentrates on identifying and discussing testing and certification requirements associated with cleanrooms. The key benefits of this course are: l
In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters.
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Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections.
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Avoid product recalls.
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Why should you attend: Regulatory agencies expect manufacturers to periodically
demonstrate that cleanrooms and controlled environments perform according to their design specifications.
Areas Covered in the Session: l l l l l l l
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.
Click here to register for this webinar
Charles Gyecsek is formerly of Hoffman LaRoche where he worked primarily in Validation, Microbiology, Quality, and Operations. During his career Charles set-up and managed one of the largest GMP cleanroom facilities in the US, encompassing more than 200 rooms in 3 separate facilities. Charles' extensive experience involves plant start-up, cleanroom design and renovation, quality system auditing, regulatory submission writing, microbiology, equipment and cleaning qualification, utility validation, water system design and validation, aseptic processing, risk management, and regulatory inspections and responses. ...more
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Who Will Benefit: l l l l l
QA personnel Regulatory personnel Manufacturing Operators Maintenance Personnel Consultants
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Operations managers Microbiologists Validation Personnel
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Training departments
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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. Best regards, Event-coordinator GlobalCompliancePanel
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