ISPE Academy

The pharmaceutical industry is a complex and ever-evolving sector that faces numerous challenges, including transparency, data security, traceability, increasing regulations, and the need for qualified professionals. Investing in staff continuing education is crucial for pharmaceutical companies, offering benefits such as market advantages, improved company morale, increased employee retention, enhanced operational maturity, and cost savings.

To address these needs, ISPE has developed the ISPE Academy, a comprehensive continuing education program. The ISPE Academy includes a certificate program that expands ISPE’s professional development offerings and supports pharmaceutical companies in workforce investment. The Academy is designed to develop and strengthen specific career skills within the pharmaceutical industry.

The ISPE Academy comprises eight distinct content areas: GMP, GAMP®, plant engineering and maintenance, pharmaceutical technologies, regulatory, manufacturing operations, capital projects engineering, and personal development.

Certificate Programs

 

GAMP Essentials

The GAMP® Essentials certificate program provides fundamental training on good manufacturing practices (GMPs) for computerized systems in the pharmaceutical and healthcare industries. It covers risk-based validation, data integrity, and regulatory requirements, aligning with guidelines highlighted in the ISPE GAMP 5 Guide (Second Edition). This program is ideal for professionals seeking to ensure compliance and data integrity in GxP-regulated environments.

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GMP Refresher

The GMP Refresher Certificate program offers fundamental training on current good manufacturing practices (CGMP) regulations, quality systems, and the distinction between quality assurance and quality compliance. This on-demand course ensures participants stay updated with key trends and regulatory requirements, providing a certificate upon successful completion.

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Pharmaceutical Water Systems

The Pharmaceutical Water Systems certificate program offers comprehensive training on the design, operation, and maintenance of water systems essential for pharmaceutical manufacturing. It covers water generation, storage, delivery, and regulatory compliance, making it ideal for professionals seeking to ensure high standards of water quality and compliance in the pharmaceutical and biopharmaceutical industries.

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FAQ

• What types of certificates do you offer?

  We offer a range of certificates in key areas such as GAMP® Essentials, GMP Refresher, Biopharmaceutical Essentials, Pharmaceutical Water Systems, and Pharmaceutical Technologies. Each certificate is designed to enhance your expertise in specific aspects of the pharmaceutical industry.

• How do I enroll in a certificate program?

  Enrollment can be completed online through our website. Simply choose the certificate program you're interested in, click "Register," and follow the prompts to register and pay for the course.

• Are there any prerequisites for enrolling in your certificate programs?

  Enrollment in this program requires applicants to hold a minimum of a bachelor's degree as a prerequisite.

• Is the certificate program self-paced?

  Most of the individual course options are live instructor-led courses that require attendance and participation. There are some courses associated with our programs that are self-paced. These self-paced items are available on-demand as computer-based training modules, allowing you to complete the coursework at your convenience.

• How long does it take to complete a certificate program?

  The time required to complete a certificate program varies depending on the course. All courses associated with the certificate programs must be completed within an 18-month period.

• What if I cannot complete all the courses within an 18-month period?

  All courses must be completed within an 18-month period or a program certificate will not be awarded. Contact our customer support team if there are extenuating circumstances preventing you from attending a live instructor-led or on-demand session.

• Will I receive a certificate upon completion?

  Yes, you will receive a digital certificate upon successful completion of all courses required for a certificate program and once you receive a passing score for the respective cumulative knowledge assessment.

• Do I need 100% to pass each knowledge assessment?

  No, a minimum score of 80% is required to pass a course-specific or overall post-instruction knowledge assessment.

• Are your certificates recognized by regulatory bodies or external agencies?

  Certificates issued are recognized by ISPE; they are not currently recognized by any regulatory authority or any other external agency.

• What is the cost of the certificate programs?

  The cost of each certificate program varies depending on the length and complexity of the program. Detailed pricing information is available on the program pages.

• Do you offer any financial assistance or payment plans?

  ISPE does not currently offer any financial assistance or payment plan for certificate programs. However, the ISPE Foundation may occasionally offer support based on donor preferences.

• How do I access the course material after enrolling?

  Once enrolled, you will receive a confirmation email with registration and login details to the virtual platform for each course. For in-person courses, materials will be shared via a SharePoint link.

• What happens if I need more time to complete the course?

  If you need additional time to complete your certificate program, please contact our support team. Extensions may be granted on a case-by-case basis.

• Is there a final knowledge assessment, and how is it structured?

  Yes, each certificate program requires a passing grade on a final knowledge assessment, typically in the form of a multiple-choice exam.

• What support is available if I have questions during the program?

  Our instructors and support staff are available to assist you throughout the program. You can reach out via email or phone for help.