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The designations are Accredited Financial Examiner, Certified Financial Examiner, and Automated Examination Specialist. Accredited Financial ExaminerCertified Financial ExaminerCertified Financial Examiner Financial AnalystAutomated Examination SpecialistCONTINUING EDUCATIONSOFE's Continuing Education Program has been established to enhance your professional standing and assist you to remain qualified as an AFE, CFE or AES. Efforts by you to comply with the requirements of the program will be fully supported by SOFE officers and state chairs through their assistance and positive reinforcement of the program on both a state and national level. CRE Reporting is Now Online: See CRE Reporting guide PDFPurposeBy continuing their professional education, members of the Society of Financial Examiners SOFE can better fulfill their obligation to competently serve the public interest. Accordingly, SOFE maintains the following continuing education program in order to assist its members in remaining current with the technical advancements and fundamental changes occurring in the operations and management of the companies they regulate. CRE Credit Requirements After a member earns either the Accredited Financial Examiner AFE or the Automated Examination Specialist AES designation awarded by SOFE, they must begin to earn Continuing Regulatory Education CRE credits effective the first day of the month following the month in which they receive the designation. If the member goes on to earn the Certified Financial Examiner CFE designation, the reporting requirements do not change. Credits must be earned in SOFE defined three year periods. The three year periods are the same for all designees; therefore, when an individual earns a designation, required credits must be prorated for the first three year period as explained in the CRE reporting section below. Beginning in 2017, and annually thereafter, those holding AFE, CFE and AES designations shall attend the NAIC Financial Condition Examiners Handbook training or the NAIC Financial Analysis Handbook training webinars, or live presentations, depending on the designation holder's primary job function. This training will count as part of the required CRE credits earned annually by SOFE designation holders.

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Application of these standards to bioprocess systems manufactured in small custom batches, especially for prototype systems used during preclinical or clinical drug process development, can be costly and burdensome and may require revalidation of sterilization of the final production design. As an alternative to a sterile label claim, many bioprocess systems may be adequately microbially controlled simply by irradiation typically in the range of 25 kGy based on dosimetry, and the standard methods for sterilization validation may not be required. The minimum 25 kGy sterilizing dose claim originated from a study performed by Charles Artandi and Walton Van Winkle in 1959. The authors determined the minimum killing dose for over 150 different species of microorganisms. As a conclusion of their study, they chose 25 kGy as the sterilizing dose, stating that this is 40% above the minimum to kill the most resistant microorganisms 9. Consequently, 25 kGy became established as a suitable minimum irradiation dose for sterilization. This historical sterilizing dose of 25 kGy also can be sufficient to eliminate viable bioburden and provide a high level of microbial control when a validated sterile claim is not required. Components or systems requiring zero or low bioburden when applied in nonsterile processes do not require a validated sterile claim and may be qualified as microbially controlled. The following section is intended to help readers determine whether validated sterilization, or more simply, microbial control, is appropriate. Biopharmaceutical manufacturing, in which drug products are produced by cell culture, can be divided into four processing stages Figure 1. In the upstream stage, nutrients and other fluids, along with the producer cells, are introduced to a fermentor or bioreactor, and the cells produce the target molecule.

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