STERILIZATION PROFESSIONAL CERTIFICATION
What is the Sterilization Professional Certification and why is it needed?
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 483’s 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.
CfPA’s 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.
Who will benefit from a Sterilization Professional Certification?
The Sterilization Professional Certification will be valuable to all individuals working within or
managing sterilization and Sterility Assurance processes that supports sterile products requiring
sterilization prior to release for use. Obtaining the Sterilization Professional Certification would
be beneficial to professionals in various industries such as the Pharmaceutical, Biotechnology, Drug,
Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially those
within the following departments:
Who is a Certified Sterilization Professional?
The Certified Sterilization Professional is an individual trained in effectively interpreting and
executing regulations associated with various sterilization and sterility assurance practices to
ensure a compliant operation. They exhibit the techniques, tools and knowledge of various aspects
of the ISO, AAMI, USP, 21 CFR Part 211 and FDA regulations amongst others which will be sufficient
to guide, facilitate and assist a company in avoiding regulatory issues and non-compliance to
various national and international regulations.
The Certified Sterilization Professional will be able to perform the following:
Benefits to the Candidate
The Sterilization Professional Certification recognizes that the Candidate has not only completed
and demonstrated proficiency in each of the required series of online courses, but also, has
achieved proficiency by mastering the overall comprehensive Certification Testing.
The distinction of a Certified Sterilization Professional can differentiate the candidate from
others within their specific industry
The Sterilization Professional Certification Program consists of a total of 10 intensive, 90-minute
courses, a total of 15 contact training hours. Candidates must complete and score at least 80% in
the Learning Assessment* for each course.
*Learning Assessment" is a means of testing that will be administered as part of each course.
This resource will be used to verify that mastery of the subject has been achieved.
How To Become Certified Sterilization Professional
Becoming a Candidate for a CfPA Online Certification is easy.
There are no additional fees beyond the standard course tuition.
Simply sign up for each course one at a time or Enroll in the entire certification program.
Pre-enrollment savings when you enroll in the entire 10 course program.
Courses included in the certification:
These courses are available from time to time in live format and are subsequently available on demand for your convenience. Check the CfPA website for the next live presentation or register at any time for the on demand course.
Courses within this or any CfPA Certification Program may be taken individually for further career advancement.