cGMP Compliance

While FDA does not mandate the frequency of cGMP training, it is essential to conduct the training at regular intervals of time instead of one massive session. The training must be conducted periodically based on employee availability, the time needed to conduct the training, type of training, whether class or online, and the establishment or removal of processes. Continuous cGMP compliance training is essential to:

• Ensure that employees remain proficient both in their operational functions and in their understanding of CGMP regulations.

• Address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture (e.g., team building, communication, change, behavior).

• Gain skills that can be implemented in the day-to-day performance.

CQ’s Training Management solution allows organizations to create and manage training programs and to quickly allocate content to the many job functions an employee may be assigned. By combining training content with developed assessments, the solution ensures that not only employees get trained but also verifies their comprehension. As part of the EQMS solution from ComplianceQuest, the training solution helps:

• Identify training gaps, missed deadlines, and overdue training so employees can remain in compliance and properly skilled as requirements change.

• Define training plans specific to particular job roles/titles to ensure position-specific functionality and compliance.

• Gain a complete view of training compliance with your documents connected to training programs and data that is stored and easily retrieved from one place.