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Cleanroom, Microbiology and Sterility Assurance Practices

  January 14, 2020  
CfPA-The Center for Professional Advancement, Edison, NJ or Virtually
May 7-8, 2020

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, Compounding Pharmacies, Cell Therapy and In-vitro Diagnostics Product Manufacturing. It will be especially beneficial to personnel and management in:
  • Quality Assurance/Control
  • Manufacturing
  • Validation
  • Regulatory Affairs
  • Sterility Assurance Manager
  • Sterilization professional
  • Shipping and Receiving
  • Engineering
  • Analytical Chemist/ Microbiologist
  • Facility and Maintenance
  • Other key management and personnel that need to provide industry training
     in these key compliance topics

Course Description
This 2-day accredited training will provide attendees a comprehensive knowledge about the A-Z of Sterility Assurance which is based on regulatory requirements, FDA guidance, compliance expectations and industry practices. Key elements of sterility assurance and contamination control which starts from creating a robust and compliant cleanroom design, validation/qualification, operations, environmental monitoring program requirements, microbiological processes/methodology, cleanroom cleaning/disinfection, trafficking, gowning requirements and contamination control will be extensively discussed. Other key aspects of achieving product sterility such as a good understanding of the basics of sterilization processes–physical and chemical processes and the various examples of sterilization equipment and their specific process parameters will also be discussed. Critical regulations affecting Sterility Assurance requirements such as 21 CFR Part 211, ISO 14644 (various parts), ISO 11135, 11137, 11138, 14160, 14937, 17664, 17665, FDA Guidance for Industry and other regulations guiding these critical topics 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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