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Cleanroom, Microbiology and Sterility Assurance Practices

 
  May 31, 2019  
     
 
CfPA-The Center for Professional Advancement, Iselin, NJ or Virtually
October 24-25, 2019


Who Should Attend?
This training will benefit those involved in the manufacturing, processing, testing and release of sterile and non-sterile products within various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries. It will be especially beneficial to personnel and management in:
  • Quality Assurance/Control
  • Manufacturing
  • Validation
  • Regulatory Affairs
  • Shipping and Receiving
  • Engineering
  • Analytical Chemist/ Microbiologist
  • Facility and Maintenance

Course Description
This 2-day accredited training addresses the various key elements of sterility assurance and contamination control such as cleanroom regulations, classification, sources and types of particles, design requirements, validation/qualification, operations, environmental monitoring program requirements, excursion investigations, data trending, microbiological processes/methodology, cleanroom cleaning/disinfection. The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through personnel training , gowning controls, cleanroom trafficking (entry and exit policy), contamination control, cleaning and disinfection program and the basics of sterilization processes–physical and chemical processes will also be discussed. The various regulatory bodies’ requirements such as 21 CFR Part 211, ISO 14644, FDA Guidance for Industry and others will be covered. Discussions will include the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products.
 
 
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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