
The Code of Federal Regulations (CFR) states that "Training in current good manufacturing practice [CGMP] shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them."
The ISPE Academy’s comprehensive GMP Certificate program includes a mandatory GMP refresher course and allows learners to customize their learning experience by selecting two out of eleven GMP Fundamentals modules.
This on-demand course provides an overview of the history, regulations, quality systems, and development, with a focus on distinguishing between quality assurance (QA) and quality control (QC) in GMP. It serves as a GMP refresher for both individuals and companies, ensuring that current key trends are covered. Upon achieving a passing grade, a certificate will be provided to verify the completion of the periodic GMP refresher regulation.
ISPE continuing education units (CEUs) are awarded once you achieve an 80% passing grade and complete the evaluation.
Learners can select two of the following eleven GMP Fundamentals modules to tailor their learning experience:
Course Title | Course Type |
---|---|
An Introduction & History of Good Manufacturing Practices | On Demand |
Organization and Personnel | On Demand |
Quality System | On Demand |
Buildings and Facilities | On Demand |
Equipment | On Demand |
Control of Excipients, Components and Drug Product Containers/Closures | On Demand |
Production & Process Controls | On Demand |
Packaging & Labeling Control | On Demand |
Holding & Distribution | On Demand |
Laboratory Controls | On Demand |
Records and Reports | On Demand |
Ala Carte Price | Non-Member Certificate Price | Member Certificate Price |
---|---|---|
$230.00 | $150.00 | $130.00 |
Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.
For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View Upcoming Courses