Course Overview:
Pharmaceutical manufacturers must comply with the regulatory requirements of the countries where they produce and sell medical products. This free, self-paced online course includes 10 modules on Good Manufacturing Practices (GMP). Basic GMP principles are specified by the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). GMPs are critical to ensuring medical products are quality-assured and fit for the intended use. Many countries have their own GMP guidelines, which are often based on the WHO standards. This course presents foundational concepts based on WHO and PIC/S principles.
Flexibility. This course is designed to allow maximum flexibility to learners. Learners freely navigate modules, completing all of them or only those that are of the most interest. Resources are provided to facilitate learning and development. There is a downloadable PDF of each module’s content to enable off-line studying if needed. However, the learning assessments must be accessed via the online eLearning module.
Learning Assessments. Each module ends with a final learning assessment. Learners have up to five (5) attempts at passing the assessment. A score of 80% or greater is required to pass. A short evaluation of each module must be completed to access the certificate of recognition. When all 10 modules have been completed, learners have the option of taking the final, summative learning assessment. A passing score (80%) releases a certificate of completion for the 10 module Foundations of GMP course.
Off-line Studying. If internet connectivity is a challenge, learners are encouraged to download the module content and study off-line. However, the module must be accessed online via the elearning module in order to take the final assessment and complete the module evaluation. Navigate through the elearning module by using the “Next” button or skipping ahead using the “Menu” tab at the top to navigate through the course.
Module Evaluations. Once the course has been successfully completed, the button on the right will change to “Evaluate”. This short evaluation will help course designers to improve course content and/or create additional GMP modules.
Certificates. Once the module evaluation is completed the button will change to “View Certificate”.
Module Completion. Module completion is achieved when all elements have been launched and marked complete and the elearning module evaluation has been taken. Note that a check indicating completion will appear just over the modules name when all requirements have been fulfilled.
In summary, welcome to the Foundations of GMP course and congratulations for taking the first step to increase your awareness of good manufacturing practices! The course was developed by the Promoting the Qual