Clean Room Design and Operation

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Description:

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 construction and the methods to demonstrate these controls are effective.

Areas to be Covered:

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

Antony J. DeMarinis

Tony DeMarinis has BS degrees in Biology & Microbiology and a MS in Quality Management. He is currently an independent Consultant specializing in Sterilization, Quality Systems, Auditing, and other Quality Management issues in the medical device and pharmaceutical industries. Previously, Tony was Director of QA/RA at Tunstall Americas for electronic monitoring devices, Quality Manager at Sealed Air for medical packaging, Quality Systems Manager at Davol for implants and surgical devices, Director of Quality Assurance at Scott Laboratories for in-vitro diagnostics and Sr. Microbiologist at the National Cancer Institute.

He is recognized as a Fellow by the American Society for Quality, and he is a Certified Quality Auditor, BioMedical Auditor, Six Sigma Black Belt, Pharmaceutical GMP Professional and Manager for Quality and Organizational Excellence. He also teaches the refresher courses for the CQA and CMQ/OE certification programs through the local ASQ sections. Tony has over 25 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.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance