Course Description

Pharmaceutical Water System: Design, Testing and Data Management

Online On Demand

Course Offering 1908901OL2879A
Course ID 2879

In-Person Course

Who Should Attend?
This training will be beneficial to professionals in the Pharmaceutical, Cell Therapy, Diagnostics, Biologics, Biotechnology and Medical Device Industries. The employees who will benefit most include personnel and management within:
  • Quality Control Analyst
  • Regulatory Affairs
  • Manufacturing Associates
  • Shipping and Receiving
  • Facility and Utility
  • Materials Handling
  • Quality Assurance Analyst
  • Supplier Quality
  • Vendors and Suppliers of Pharmaceutical Water Systems and Peripherals

Site Directors, Operations Director and Senior Management will also find this training valuable.

Course Description
This 90-minute accredited training will guide a drug product manufacturer with effectively designing, validating and maintaining a new or existing water system. The appropriate design planning considerations, validation, types of routine tests, testing frequencies, water system maintenance and how to set an acceptable alert and action levels will be reviewed. Water test result/data management and trending which will be a guide to a steady state of control of the different water systems will be presented. This will benefit the manufacturers by helping to avoid future costly pharmaceutical water systems failure, investigations or inability to validate or achieve passing test results from a new or existing water systems emanating from design-related issues.

Course Director
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.