Course "Learning Management Systems (LMS)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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 curriculum is not
- Why is setting up curricula so complicated?
- Obtain details of employee job functions that are necessary for setting up curricula
- Demos and hands-on activities for employees
- Knowledge assessment and review
Day 1 Schedule
Lecture 1 (90 Mins): Introduction to Pharma curricula - basic premise, regulatory requirements, knowledge check
Lecture 2 (90 Mins): Components of Pharma curricula - core curricula, job-specific curricula, modules, knowledge check
Lecture 3 (90 Mins): Relation between job descriptions and Pharma curricula, complications in curriculum structuring(job related, LMS-related)
Lecture 4 (90 Mins): Hands-on activities for basic curriculum and module setup outside of the LMS (conceptual)
Day 2 Schedule
Lecture 1 (90 Mins): Learning Management Systems (LMSs) and their relation to curricula
Lecture 2 (90 Mins): LMS functionality (employee information, training course entry, training completion entry) with demos and hands-on activities
Lecture 3 (90 Mins): Processes for curriculum revisions: regulatory requirements, LMS-related complications and how to manage these
Mr Michael Esposito,
Pharmaceutical Trainer ,
Michael Esposito has 30 years experience in the pharmaceutical industry and 13 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.
Who will benefit:
This course will be of benefit to training employees, both individual contributors and management, who are responsible for the creation and management of Pharma training curricula such as:
- LMS administrators
- Training managers and their supervisors
- Subject matter experts
- Regulatory management
- QA management
- Quality Managers
- Audit Managers
- Quality Analysts
Courtyard Arlington Crystal City/Reagan National Airport
2899 Jefferson Davis Highway