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Frequently Asked Questions (FAQs)

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Is the CPIP certification program being changed?

ISPE’s certification program, CPIP, will evolve to a re-certification program as of 30 November, 2013.

  • Professionals who are currently holding the CPIP credential will be able to maintain that credential and be recognized for demonstrating the level of competence required to achieve it as long as they continue to meet recertification guidelines.
  • Professionals currently in the process of seeking the credential will have until 31 May 2014 to complete all requirements.

Is the CPIP certification program still open to new candidates?

  • Yes, the opportunity to obtain the CPIP credential will be available for a limited period of time. New candidates must meet the eligibility requirements and submit an eligibility application by November 30, 2013, complete relevant interim steps and pass the examination before May 31, 2014.

I am a CPIP; how do I maintain my credential?

  • CPIPs retain their status and can continue to use the letters CPIP after their names as long as they maintain their credential. This occurs through recertification using the existing recertification process.
  • CPIPs whose recertification status is currently suspended or overdue -- but who wish to continue as CPIPs -- must bring their credential up to date by March 31, 2014, or have their credential permanently revoked.

What about professionals currently in the process of seeking the CPIP certification?

Professionals currently in the process of seeking the credential will have until 31 May 2014 to complete all requirements including successfully passing the exam.

  • Professionals who submitted eligibility applications before June 1, 2013, and whose eligibility has been approved, may submit an examination application, schedule and take the examination prior to May 31, 2014. If successful they will be awarded the CPIP certification and could maintain certification through the CPIP recertification process.
  • Professionals who submitted eligibility applications after June 1, 2013, and whose eligibility has been approved may choose from two alternatives:
    • They may submit an examination application, schedule and take the examination prior to May 31, 2014. If successful they will be awarded the CPIP certification could maintain certification through the CPIP recertification process.
    • Alternately, they may request a refund of their eligibility application fee.
  • Professionals who submitted an eligibility application after June 1, 2013, and whose eligibility is pending may complete the eligibility process, submit an examination application, schedule and take the examination prior to May 31, 2014. After passing the exam, these professionals could maintain the CPIP credential through the recertification process. Alternately, professionals in this situation may request a refund of their eligibility application fee.

When can the CPIP eligibility application be submitted?

CPIP candidates must meet the eligibility requirements and submit an eligibility application by November 30, 2013.

Is the CPIP credential available only to ISPE members?

The CPIP credential may be obtained by ISPE members and non-members alike.

Have the eligibility requirements for the CPIP credential changed?

How do I apply for eligibility?

The CPIP Eligibility Application Handbook contains the instructions to submit the application.

What are the eligibility requirements for the CPIP credential?

Two eligibility requirements must be met, Education and Experience.

Candidates with a bachelor’s (or higher) or the global Equivalent

Education Requirements:

  • A bachelor’s or higher (or globally equivalent university degree) from an educational institution accredited by a generally-recognized accrediting body (e.g., ABET, SACS, UK Science and Engineering Research Council)
  • A candidate who has earned one or more advanced degrees (such as a Master’s or Doctoral Degree) will receive credit for one year of experience (see Experience Requirements below)

Experience Requirements:

  • Three (3) years of documented drug product development/ manufacturing pharmaceutical/biotechnology industry-related experience.
    OR
  • Five (5) years of documented experience in an industry other than the pharmaceutical or biotechnology industries.

For Candidates with a Secondary diploma (high school or the global equivalent)

Education Requirements:

  • A secondary diploma (high school or the global equivalent) or associates degree or global equivalent

Experience Requirements:

  • At least seven (7) years of documented drug product development/ manufacturing pharmaceutical/biotechnology or life sciences industry-related experience.
    OR
  • Ten (10) years of documented experience in an industry other than the pharmaceutical or biotechnology industries.

What is the cost to apply for the CPIP credential?

Fees for ISPE Members are:

  • Eligibility Application: US$175.00, €135.00
  • Examination: US$350.00, €269.00
  • Recertification: US$225.00, €180.00

Fees for ISPE Nonmembers are:

  • Eligibility Application: US$275.00, €212.00
  • Examination: US$460.00, €354.00
  • Recertification: US$225.00, €180.00

All fees are nonrefundable and subject to change at any time without notice.

Will the applicants be required to take and pass an examination for the CPIP credential?

  • Yes, once deemed eligible, successfully passing the CPIP examination is required to become certified.
  • Candidates must submit the examination application, take and pass the examination prior to 31 May 2014.

Is there a minimum or maximum time from the date of eligibility until the examination must be taken?

Eligible candidates may apply to take the examination at any time after the date of eligibility that they feel ready. However, when the examination application is submitted and approved, the Candidate receives an Authorization to Test (ATT) requiring them to schedule and complete the examination within a six-month period or prior to 31 May 2014, which is the last day that the examination will be offered

If the exam is not passed, what is the retest procedure?

  • Candidates who take and fail the CPIP certification examination prior to 31 January 2014 may retake the examination in 90 days. They must apply and retake the examination prior to 31 May 2014.
  • Candidates must pay appropriate exam fees, submit a new examination application form (CPIP-TA-1) and continue to meet the eligibility criteria.
  • Candidates who take and fail the examination after 31 January 2014 will not have an opportunity to re-take the examination.

Is the examination “open book”?

No. It is closed book other than requested and approved translation dictionaries. Refer to the CPIP Eligibility Application Handbook for a description of approved dictionaries.

Is a study guide available to help CPIP candidates prepare for the examination?

A Study Guide is available for purchase. The Study Guide gives the candidate a description of each knowledge area covered on the examination as well as the percent of exam questions for each knowledge area. The Study Guide also lists study references, cited by the exam question developers, and techniques to help candidates prepare for the exam. A practice exam (questions and answers) is also available on the website.

How much study time should I expect to prepare for the examination?

  • The amount of preparatory time will vary for each candidate. Study time is largely dependent upon each candidate's work experiences and familiarity with the knowledge topic. All of the study guide references total between 60 and 100 typewritten pages.
  • The CPIP practice exam can be taken and used as a knowledge gap analysis tool identifying the knowledge areas requiring study.

Will re-certification be necessary?

  • The CPIP credential is valid for three years and requires recertification to continue using the CPIP designation.
  • For recertification, CPIPs will need to submit a simple annual recertification application and certification maintenance fee ($75.00/year) – this requirement is unchanged.
  • For recertification, CPIPs will also need to document professional development and acquisition of knowledge activities during the three year validity period. There are 9 professional development and acquisition of knowledge activities to choose from – this requirement is unchanged.
  • CPIPs will need to document these activities to achieve 60 recertification points over the three year period in order to be recertified. This requirement is unchanged.

Whom should I contact if I have a question not on this list?

  • Questions specific to the CPIP credentialing program or to individuals’ status with regard to CPIP should be directed to Michael Phelan, Director of Professional Certification, via email mphelan@ispe.org or telephone +1.813.960.2105.
  • Questions related to ISPE’s Member and Industry Services in general should be directed to Karleen Kos, Vice President of Member and Industry Services, via email kkos@ispe.org or telephone +1.813.960.2105.

Sam DeMarco, CPIP, President Compliance Team Inc, United States

"I believe that the credential has made me more confident and I feel that my clients engage me in more philosophical discussions on pharmaceutical industry subject matter. I get the sense that my clients 'listen' to me in a more serious 'in tune' way."

Marc Fleischman, CPIP, Facility and Verification Engineer, Genzyme, a Sanofi Company

"I chose to pursue the CPIP certification as a way to learn new phases of the industry and to codify my existing knowledge. As I prepared and studied for the exam, I was challenged to develop a broader understanding of many industry concepts that I had not been routinely exposed to. The experience has left me with a deep understanding of GMP regulation and broad industry knowledge across the entire bio/pharm lifecycle."