Lyophilization: What you Need to Know, Validation and Regulatory Approaches

Live Webinar on

Lyophilization: What you Need to Know, Validation and Regulatory
Approaches
Date & Time:


Thursday, July 07, 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 the science and art of lyophilization and
Senior Consultant, Biologics
discusses how the lyophilization cycle and process is developed and
Consulting Group, LLC
validated, along with the regulatory requirements for lyophilization.

John currently works for the
Lyophilization is complex and this seminar will break the process
Biologics Consulting Group as a
down so that it can be more easily understood. The important
Senior Consultant. John served as a
aspects of how FDA inspects and regulates the lyophilization
Senior Review Biochemical Engineer
and Lead cGMP inspector in the
process, equipment, and controls will be discussed. The science and
Division of Manufacturing and
art of how to develop lyophilization cycles will be discussed.
Product Quality at CBER, FDA. He
Lyophilization controls, including computer controls and validation will
contributed to formulation of FDA
be explored. Quality aspects of lyophilization including obtaining a
policy. He has audited/inspected
resulting quality product will be discussed.
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
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Science of Lyophilization
design, best practices, and validation
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Cycle development and tools
approaches that meet FDA licensing
l
Validation of the Lyo Cycle
requirements. John received his B.S.
l
Lyo equipment validation
in chemical engineering from N.C.
l
Regulatory requirements
State University and his M.S.E. in
l
How the lyo process and equipment are inspected
biochemical engineering from Johns
l
The science and the art
Hopkins University. ...more
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Who Will Benefit:
Your Necessity is our Priority
l
Compliance Manager
l
Process Engineer
l
Validation Manager
l
Regulatory Manager

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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