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
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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.
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.
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.
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. These self-paced items allow you to complete the coursework at your convenience, making it easier to balance your studies with professional and personal responsibilities.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. Each course has been video-recorded; on a case-by-case basis, ISPE may be able to provide an attendee with a video recording instead of requiring live attendance. Contact our customer support team if there are extenuating circumstances preventing you from attending a live instructor-led or on-demand session or if you have any additional questions or need further assistance: we are available via email at ask@ispe.org or by phone at +1-813-960-2105.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. Digital certificates are awarded within 14 days of passing all of the course criteria. The digital certificate will be available for download from your ISPE account in your certificate dashboard (via a ribbon icon).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. A passing score is not needed for a pre-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 ISPE Academy program pages. We also offer discounts for group enrollments and ISPE members.Do you offer any financial assistance or payment plans?
ISPE does not currently offer any financial assistance or payment plan for certificate programs. However, from time to time, ISPE Foundation may receive a donation that, based on the donor’s preferences, could help supplement the cost of tuition for participating in a certificate program. To learn more about the ISPE Foundation, visit ISPEFoundation.org.How do I access the course material after enrolling?
Once you’ve enrolled in a certificate program that has a virtual instructor led course, you will receive a confirmation email with registration and login details to the virtual platform for each course, typically one week prior to a course’s start date. If you attend an in person course, course materials will be shared with you via a SharePoint link. You can access the course materials via a link in the virtual platform or the SharePoint link: you can download PowerPoint slides, exercises, handouts, etc. If you have any additional questions or need further assistance: we are available via email at ask@ispe.org or by phone at +1-813-960-2105.What happens if I need more time to complete the course?
We understand that unexpected circumstances may arise. If you need additional time to complete your certificate program or individual course, please contact our support team via email at ask@ispe.org or by phone at +1-813-960-2105. We will consider granting extensions on a case-by-case basis.Is there a final knowledge assessment, and how is it structured?
Yes, each of the certificate programs require a passing grade on a final knowledge assessment. Each assessment, which typically takes the form of a multiple-choice exam, will be accessible from your certificate dashboard once all courses have been completed.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 at ask@ispe.org or by phone at +1-813-960-2105, if you need additional help.How do I claim my continuing education units (CEUs)?
You will receive a certificate that can be used to claim your ISPE CEUs once you have successful completed the certificate program. You will also be awarded ISPE CEUs upon completion of each course.Can I retake the course or assessment if I’m not satisfied with my performance?
If you are not satisfied with your performance, you may not retake a course-specific knowledge assessment or the overall post-instruction certificate knowledge assessment. Three attempts are allotted for each course knowledge assessment. If you haven’t successfully completed the assessment within three attempts, you may purchase three additional attempts at a discounted rate. Please contact our support team via email at ask@ispe.org or by phone +1-813-960-2105 for more details on our retake policy.What if I lose my certificate?
Certificates of completion are available through your certificate dashboard. Contact our support team or revisit your account if you misplace or lose access to your certificate.Are there opportunities for advanced or follow-up courses?
Absolutely! We offer a variety of courses for those looking to deepen their expertise on various topics related to the pharmaceutical industry. To learn more, visit our training website Pharmaceutical Training | ISPE | International Society for Pharmaceutical Engineering or contact our support team via email at ask@ispe.org or by phone +1-813-960-2105.- No, if you took a course through ISPE that is required as part of a specific certificate program, your certificate dashboard will automatically reflect that a course has been completed: this course will be counted toward your overall progress. If you took the course through a local ISPE Affiliate or Chapter, please e-mail proof of your course completion to training@ispe.org and we will unlock the respective course knowledge assessment for you. A previously attended course must be within 12 months of the start of your enrollment in a certificate program. If you feel that you need a refresher on any course, you are welcome to retake the course. No financial credit will be given towards any courses taken more than 12 months after the start of enrollment in a particular certificate program, since certificate programs already include discounted courses from typical the a la carte course pricing.
Who can I contact for more information?
If you have any additional questions or need further assistance, please don’t hesitate to contact our customer support team via email at ask@ispe.org or by phone +1-813-960-2105. We’re here to help!- In your ISPE Academy dashboard, register for these items by clicking the red Register button. Once registered, click the “Launch Course” Link under the title of the knowledge assessment or course.This will direct you to Top Class, where you can complete the on-demand portions of the certificate such as knowledge assessments and/or on demand courses.
- This is a technical issue that we are working to resolve. Once you are in Top Class, click on My Learning Center. Once in My Learning Center, click the “Sync Latest Data” link at the top. This should sync all of your current on-demand certificate knowledge assessments and/or courses that you have registered for.