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

 
  December 24, 2010  
     
 


GlobalCompliancePanel, Online Training Webinar
2011-02-24


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
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: 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.
 
Deadline for Abstracts: 2011-02-24
 
Registration:
Thursday, February 24, 2011  
10:00 AM PST | 01:00 PM EST
Live live online training only for one participant
Price: $245.00
 
 
 
Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
Price: $995.00
 

Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
 
E-mail: webinars@globalcompliancepanel.com
 
   
 
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