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Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
- Added: June, 21st 2011
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Live Webinar on
Pharmaceutical and Biologics Facility Design: FDA and Regulatory
Aspects
Date & Time:
Thursday, July 21, 2011
10:00 AM PDT | 01:00 PM EDT
Register Now
Duration: 60 Minutes
Instructor: John R. Godshalk
Location: Online
Price : $245.00 (for one participant)
Instructor Profile:
Overview:
John R. Godshalk
This course explores some of the best practices of pharmaceutical
Senior Consultant, Biologics
facility design with an emphasis on the regulatory aspect.
Consulting Group, LLC
FDA and other regulatory body requirements are discussed and the
John currently works for the
reasoning behind them. Examples of floorplans and flows (people,
Biologics Consulting Group as a
equipment, etc.) are examined and discussed. Specifics for fixtures,
Senior Consultant. John served as a
finishes, HVAC and other design aspects of cleanrooms are discussed
Senior Review Biochemical Engineer
and Lead cGMP inspector in the
in terms of currentpracticesandGMPrequirements.Examplesof
Division of Manufacturing and
design choices for pressurization, flows and HVAC zones are given
Product Quality at CBER, FDA. He
along with their possible application. Design specifications for both
contributed to formulation of FDA
open and closed systems are discussed along with current
policy. He has audited/inspected
standards.
hundreds of pharma and biotech
companies and reviewed processes
and PV at these plants. John has
Areas Covered in the Session:
provided advice to industry on
regulatory strategies,
pharmaceutical product facility
l
Best design practices for Pharma facilities
design, best practices, and validation
l
Best design practices for biologics facilities
approaches that meet FDA licensing
l
Regulatory compliance for Pharma and biologics facilities
requirements. John received his B.S.
design
in chemical engineering from N.C.
l
Flow patterns and cross contamination controls
State University and his M.S.E. in
l
Design criteria for fixtures and finishes
biochemical engineering from Johns
l
Examples of good design
Hopkins University. ...more
l
General specifications for different classification zones
l
Examples of design specs for cleanrooms
Suggest a Topic
More Webinars
Click here to register for this webinar
Your Necessity is our Priority
Who Will Benefit:
l
Compliance Manager
l
Facility Manager
l
Validation Manager
l
Regulatory Manager
l
Design Team/Architects
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
About GlobalCompliancePanel
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