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Does your Equipment Program meet current regulatory expectations? - Webinar By GlobalCompliancePanel

 
  February 02, 2011  
     
 


GlobalCompliancePanel, Online Training Webinar
2011-03-10


Overview: This Interactive webinar will begin with an overview of the GMP/GLP requirements for an Equipment system.

The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/GLP compliance will be reviewed.

Why you should attend: The equipment Program is a critical component of both GMP and GLP laboratories. It contributes to the quality and therefore reliability of the generated data which is required for critical for go-no-go decisions. An effective Equipment Program is also an expectation in GLP and GMP laboratories.

Areas Covered In the Seminar:
  • FDA requirement for Equipment systems
  • Overview of GMP/GLP requirements for equipment
  • IIQ/OQ/PQ of Equipment
  • Equipment database
  • Equipment SOPs
  • Equipment Calibration and maintenance
  • Review of equipment related citations in recent Warning Letters
Who will benefit: This course is intended to provide training how to perform OOS/OOT investigations
  • QC Supervisors and Management
  • QA personnel
  • QA Management
  • Documentation management specialists
  • Regulatory affairs personnel
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: Dr. Subbarao received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases. She is an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She serves on the AAPS Stability Focus Group Steering Committee. She also serves on the AAPS National Biotechnology Conference Programming Committee for 2009 to 2011 as the Regulatory Sciences lead.
 
Deadline for Abstracts: 2011-03-10
 
Registration: Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
E-mail: webinars@GlobalCompliancePanel.com
 
   
 
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