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CAPA: A Critical Quality System Requirement

  April 24, 2019  
CfPA-The Center for Professional Advancement, Online Live
July 16, 2019 at 11:00 a.m.–12:30 p.m. (ET)

Who Should Attend?
This training will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries personnel within the following departments:
  • Quality Control Personnel & Management
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Supplier Quality Personnel & Management

However, if you are already familiar with CAPA and its requirements, you may recommend this training to anyone in your company that may require additional knowledge about this subject.

Course Description
There has been several form 483’s and warning letters being issued to companies by the FDA as it relates to CAPA investigation because of insufficient or incomplete quality systems procedures applicable to corrective action and preventative action programs (CAPA). Addressing an FDA form 483 with findings associated with CAPA systems must be performed adequately, complete and must provide enough details within the CAPA procedures to ensure an effective CAPA investigational procedure. All failure, deviation or out of specification investigations must be adequately documented, corrected, prevented and checked for corrective action effectiveness through the use of a compliant CAPA investigational system and program. The result of a product investigation impacts the quality of the cGMP manufactured product label claim, to avoid it from being termed ‘adulterated” by the FDA which may result in product recalls, complaint and further actions by the FDA.

This 90-minute accredited training will benefit manufacturers of cGMP products in designing an effective, robust and compliant CAPA investigation system in order to avoid FDA or other regulatory bodies’ inspection findings in these areas. It will also be a great resource to Quality Assurance, Manufacturing, Regulatory Affairs and Quality Control personnel and management within the Pharmaceutical, Biotechnology and Medical Device companies. 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Charity Ogunsanya, (Owner/CEO), Pharmabiodevice Consulting LLC

Charity Ogunsanya has more than 28 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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