Sterilization Professionals Certification Program

Charity Ogunsanya

Course description

In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of products must manufacture products that meet defined specifications. Developing processes that are adequate to produce medical devices or other products that requires a defined Sterility Assurance Level (SAL) requirements, testing specifications, validating or fully verifying the results of those processes, including monitoring and controlling the processes are all steps that help assure that the result of the manufactured products meet the defined specifications.

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that are critical to a product’s sterility including inappropriately qualified and trained personnel required as key staff to implement a fully compliant sterilization process. This can potentially lead to Product Failures (Sterility Failures), product Non-conformances, Product Recalls, FDA’s Warning Letters, Consent Decrees and discontinuance of commercial operations which may negatively impacts a company’s profitability. FDA regulated industries that produce products with a defined SAL are obligated to have adequately trained and knowledgeable staff or Subject Matter Experts (SMEs) within sterilization and sterility assurance to provide applicable regulatory guidance with the impacted systems.

Cobblestone’s 10-Part Sterilization Professional Certification program provides detailed training on the key principals and tools required to become a Sterilization Professional which starts from the concept of understanding what a Microorganism is through the various aspects of Aseptic Process requirements, different types of sterilization systems/processes that are applied within the industries to achieve their unique or desired product SAL in conjunction with an effective Cleanroom Controls which is an integral part of the sterilization process controls. This Certification Program offers professionals a detailed and expansive training and development skills with a broader understanding in the area of sterilization which is required in order to attain a certificate of accomplishment.

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

• Interpret the various Sterilization and Sterility Assurance regulations, standards and requirements
• Apply regulatory requirements to routine operational sterilization and sterility assurance applications
• Plan and manage sterilization process controls to minimize product non-conformances and product sterility failures and investigations
• Train and mentor internal sterilization, manufacturing, sterility assurance and other critical staff on various types of sterilization process requirements including the qualification and requalification requirement
• Develop various types of Sterilization and Sterility Assurance Process Standard Operating Procedures (SOPs)
• Prepare and Execute IQ, OQ and PQ protocols and draft reports for various sterilization processes and systems
• Perform effective technical audits of Sterilization Process Suppliers and Vendors using key audit review requirements applicable to sterilization and cleanroom controls
• Represent an organization as a Sterilization and Sterility Assurance Subject Matter Expert (SME) during FDA and other International Regulatory bodies’ inspections
• Interact with management, regulators and other external auditors.

Courses Included in this Certification:

Basics of Microbiology
Requirements for Aseptic Techniques and Practices
Basics of Electron Beam Sterilization Process Requirements
Basics of Gamma Radiation Sterilization Process Requirements
Basics of Ethylene Oxide Sterilization Process Requirements
Basics of Vaporized Hydrogen Peroxide (VHP) Sterilization and Decontamination Practices
Requirements of Aseptic Processing and Filtration Sterilization
Basics of Sterilization by Heat
Cleanroom, Microbiology and Sterility Assurance Practices for Sterilization
Cleaning, Sanitization and Disinfection Practices