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Qualification/Validation for Bacterial Endotoxin Testing (BET)

 
  April 16, 2013  
     
 
CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
June 5, 2013 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend
This training applies to personnel/companies in the Pharmaceutical, Biotechnology and Medical Device Industries. The employees who will benefit most include:

  • Quality Control Analyst and Management 
  • Senior Management 
  • Manufacturing Associates and Management
  • Quality Assurance Analyst and Management

Those familiar with the Bacterial Endotoxin Testing (LAL), Product Validation and Suitability Tests may wish to recommend this webinar to anyone in their company that has questions about this subject.

Description
cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable so as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone. Attendees will be able to understand the steps and requirements associated with product qualification and validation as a prerequisite to routine LAL testing.

This 90-minute, accredited training will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries that manufacture cGMP product requiring bacterial endotoxin release assay.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Charity Ogunsanya has more than 23 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 for multiple fortune 100 companies.

She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and is currently in the Advanced Academic Master’s Biotechnology Program at the Johns Hopkins University with concentration in Biodefense.

She is the CEO/Owner of Pharmabiodevice Consulting LLC, which 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: sberg@cfpa.com
 
   
 
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