Validation and Regulatory Approaches in 2016 by Compliance4all

  • September 26, 2016
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Validation and Regulatory Approaches in 2016 by Compliance4all

Overview:  
This webinar explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.

Lyophilization is complex, and this seminar will break the process down so that it can be more easily understood. The important aspects of how FDA inspects and regulates the lyophilization process, equipment, and controls will be discussed. The science and art of how to develop lyophilization cycles will be discussed. Lyophilization controls, including computer controls and validation will be explored. Quality aspects of lyophilization including obtaining a resulting quality product will be discussed.

Why should you Attend:
The attendee will learn how lyophilization cycles are developed, how lyophilizers work and how they are controlled and what is important to FDA and other regulatory bodies in the inspection of lyophilizers and in the validation process.

Areas Covered in the Session:
Science of Lyophilization
Cycle development and tools
Validation of the Lyo Cycle
Lyo equipment validation
Regulatory requirements
How the lyo process and equipment are inspected
The science and the art

Who Will Benefit:
Compliance Manager
Process Engineer
Validation Manager
Validation Engineer
Regulatory Manager

Speaker Profile:
John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy. He has audited/inspected hundreds of pharma and biotech companies and reviewed processes and PV at these plants.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/


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