Cleanroom, Microbiology and Sterility Assurance Practices

Duration: 12 Hours
Course Instructor

Charity Ogunsanya

$ 2150
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

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This intensive course provides 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 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.

Upon completion of this course, you will be able to:

  • Explain the detailed requirements of the various cleanroom classifications per ISO 14644 and expectations based on the regulations and guidelines.
  • Apply best practices in the design of a new cleanroom through qualification/validation, operation and routine environmental monitoring program.
  • List FDA and regulatory guidance and expectations on aseptic and personnel health practices, gowning and trafficking patterns within a cleanroom.
  • Apply industry guidance and the requirements of how to create a robust cleanroom cleaning/disinfection and contamination control programs to achieve a high degree of sterility assurance.
  • Explain in detail the two types of sterilization processes with detailed description of each type, parameters as well as their advantages and disadvantages.
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This training will benefit those involved in the manufacturing, processing, testing, and release of sterile and non-sterile products within various industries such as Pharmaceuticals, 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

Course Instructor


Charity Ogunsanya

Owner/CEO, Pharmabiodevice Consulting LLC

Charity Ogunsanya’s Courses


Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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