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Cleanroom and Sterility Assurance in a Nutshell

  January 17, 2020  
CfPA-The Center for Professional Advancement, Online Live
March 24, 2020 at 9:00 a.m.–1:00 p.m. (ET)

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
  • Facility and Maintenance
  • Analytical Chemist/ Microbiologist

Other key management and personnel that need to provide industry training in these key compliance topics will benefit from this course as well.

Course Description
This half day accredited training addresses fundamentals and key principles of cleanroom technology for the pharmaceutical, medical device, clinical and non-clinical arenas. Among many other pertinent topics, this course will cover regulations, classification, particle sources, design, validation/qualification, environmental monitoring and microbiological processes/methodology. The types of microorganisms, typical contamination control mitigation steps, and the basics of sterilization processes (physical and chemical) will also be discussed as well as personnel training, gowning, and cleaning/disinfection. Discussions will include the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products along with various regulatory requirements.
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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