Aspects to Consider for Clean Room Qualification and Operation

Training Options

  •   Duration: 60 Minutes  
  • 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
  • Refund Policy

Overview:

Controlled environmental conditions are often used when making medical devices and pharmaceuticals. However, to make sure these clean rooms are continuously operating in a state of control can be a difficult task unless the appropriate controls are incorporated into the design.

This talk will focus on the controls that need to be considered during the design and contruction and the methods to demonstrate these controls are effective.

Areas Covered in the Session:
  • Clean Room Classification Design and Operation
  • Engineering and Budget Considerations
  • Air Filtration and Maintaining Positive Pressure
  • Interlocks and Pass Throughs
  • Controlling Human Factors
  • Acceptance Criteria
Who Will Benefit: This discussion will benefit any organization that wants to improve the control of their current clean room faclity or those considering building or upgradeing their clean rooms. It should be of interest to:
  • QA and Manufacturing Managers
  • Engineers
  • Supervisors
  • consultants
  • Auditors responsible for designing or qualifying controlled environments or operating within them
Tony has BS degrees in Biology & Microbiology and a MS in Quality Management. He is currently Quality Manager at Sealed Air, a supplier of rigid medical device packaging solutions. Previously he was Quality Systems Manager at Davol, Director of Quality Assurance at Scott Laboratories and Sr. Microbiologist at the National Cancer Institute. He is a Certified Quality Auditor-BioMedical and Certified Manager of Quality and Organizational Excellence by the American Society for Quality. He also teaches the refresher courses for these certification programs through the local RI-ASQ section. Tony has over 20 years experience using quality management techniques and value added auditing including the use of Failure Investigation and Root Cause Analysis to improve processes and products


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