Time: 9:00 AM to 6:00 PM
Venue: Courtyard Arlington Crystal City/Reagan National Airport
**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
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).
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.
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)
|1||2 Attendees||10% off|
|2||3 to 6 Attendees||20% off|
|3||7 to 10 Attendees||25% off|
|4||10+ Attendees||30% off|
To avail the above group discounts, all the participants should register by making a single payment
Call our representative TODAY on 1800 447 9407 to have your seats confirmed!
Michael Esposito has over 30 years experience in the pharmaceutical industry and 17 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 organizations GMP Training Educators Association and Association for GXP Excellence and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.