Mon Oct 22, 9:00 AM - Tue Oct 23, 6:00 PM

Courtyard Arlington Crystal City/Reagan National Airport

2899 Jefferson Davis Highway Arlington, VA 22202 USA, Washington, DC 22202

Community: Upper West Side

Description

Your company's SOPs will typically require periodic, documented review of curricula. Curricula frequently change as SOPs are being created or revised, and a curriculum owner may require specific training prior to being authorized to approve a curriculum.

Event Details

Overview:
This course will describe the development of job position curricula in the pharmaceutical industry using a Learning Management System (LMS) and provide you with the tools needed to create effective curricula.
A Pharma curriculum is the sum total of all the courses that an employee in a specific position requires, and is composed of smaller groups of courses called modules. A curriculum typically will include a "core curriculum" (usually several modules) with all the required courses for all employees involved in GMP functions, a "job-specific" group of courses for the position, modules reflecting further subdivision of responsibilities within individual positions, roles in validated computer systems such as investigations, and roles in applicable hard-copy review processes.
Curricula, like SOPs, are controlled documents requiring review and signature. Your company's SOPs will typically require periodic, documented review of curricula. Curricula frequently change as SOPs are being created or revised, and a curriculum owner may require specific training prior to being authorized to approve a curriculum.
The individual designated as owner of a given curriculum should be someone who knows enough about specific roles in their organization. Curricula for GMP-regulated tasks that the user performs directly require the inclusion of assessments (knowledge or skill).
Why you should attend:
Learning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training, and their GMP compliance, up to date. They often boast great functionality but also have limitations that must be overcome for a Pharma company to use them effectively. An area that is not understood well is the development of training curricula in these systems, which presents its own unique challenges and takes far more time to implement than is commonly thought. In addition, many employees have these responsibilities in addition to others not necessarily related to training and do not have the luxury of time to create and maintain a complex array of curricula.
Areas Covered in the Session:
• What a true Pharma curriculum is
• Requirements for Pharma curricula
• What a true Pharma

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