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Performing an Effective Sterility Failure Investigation

 
  June 05, 2017  
     
 
CfPA-The Center for Professional Advancement, Online Live
July 20, 2017 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend?
This 90-minute webinar will provide a great resource to personnel involved within the following departments in the Pharmaceutical, Biotechnology, Diagnostics, Drugs, Cell Therapy, Biologics, Raw Material, Excipients, Chemicals and API Suppliers, and Medical Device industries:

  • Quality Assurance/Control
  • Sterility Assurance
  • Manufacturing/Production
  • Senior Management
  • Raw Materials Tester
  • Supplier Quality
  • Regulatory Affairs/Compliance
  • Design Engineers
  • Facility, Maintenance and Engineering
  • Contract Manufacturing Organizations (CMO)
  • API, Chemical and Excipient Suppliers

Course Description
Performing an effective, robust, complete and compliant sterility test result failure investigation is an effective tool that helps to prevent future loss of product, regulatory filed complaint and product recalls. Further contamination of subsequently manufactured batches of finished products, raw materials, bulk drug substance or excipient may be prevented if the source of the contaminant is clearly identified at the onset of the initial sterility test failure investigation.

This 90-minute training will provide an understanding of the regulations guiding the sterility testing program and the process of conducting an effective, robust and compliant sterility test investigation for various types of sterile products. The content of a sterility test investigation form will be shared with the attendees as a tool that may be used when designing a sterility failure investigation program.

Can't Make this LIVE Webinar? 
Simply select the On Demand option when registering and we will send you the link to view the recorded version.

This course will be available On Demand: July 21, 2017
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Charity Ogunsanya, (Owner/CEO), Pharmabiodevice Consulting LLC

Charity Ogunsanya has more than 26 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and has a Masters degree from the Advanced Academic Master’s Biotechnology Program at the Johns Hopkins University with concentration in Biotechnology/Biodefense. She is the CEO/ Owner of her consulting firm named Pharmabiodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
 
   
 
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