CPIPSM Exam Item-Writer Qualification Criteria
These criteria will be used by the ISPE-PCC Examination Development Committee in reviewing candidate CPIP exam item-writer qualifications and determining acceptance or denial as an item-writer.
Primary Criteria
Education and Experience
Fifteen years minimum combined Education and experience.
The experience must have been gained working in the pharmaceutical or biotech industry. The education degree held must have been a minimum of a Baccalaureate Degree or globally equivalent University Degree earned from a learning institution accredited by a generally recognized accreditation agency.
Work and Job Position History
Currently in a position interfacing with people or process and a demonstrated progression of various positions in the pharmaceutical/biotech industry.
Professional Development
Demonstrated currency with pharmaceutical/biotech development and/or process technology in the form of presentations given, papers published, awards, patents, or other forms of recognition.
Secondary Criteria
Demographics
- Country of origin/residence and employment (Oceana, Europe, NSC America)
- Drug product manufacturer, professional service provider, equipment/systems supplier
- Large multinational companies, small to medium domestic companies
CPIPSM Exam Item-Writer Submission Requirements
To be considered as a item writer (SME):
submit a current CV (WORD document) and write a statement (WORD document) explaining what part of your education/work experience is most aligned with one of the seven knowledge elements of CPIPSM competency 1.
Read more about the CPIPSM technical competency #1. (Word DOC, 96 KB)
Submit WORD documents to Jerry Roth, P.E., Director Professional Certification jroth@ispe.org.












