BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T083330Z UID:17704ef0-baa7-4a7b-982c-c62186af9b8b DTSTART:20210420T090000 DTEND:20210421T090000 CLASS:PRIVATE DESCRIPTION:
This course wi ll describe the development of job position curricula in the pharmaceutica l industry using a Learning Management System (LMS) and provide you with t he tools needed to create effective curricula.
\n\nA Pharma curricul um is the sum total of all the courses that an employee in a specific posi tion requires\, and is composed of smaller groups of courses called module s. A curriculum typically will include a "\;core curriculum"\; (us ually several modules) with all the required courses for all employees inv olved 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.
\ n\nCurricula\, like SOPs\, are controlled documents requiring review an d signature. Your company'\;s SOPs will typically require periodic\, do cumented review of curricula. Curricula frequently change as SOPs are bein g created or revised\, and a curriculum owner may require specific trainin g prior to being authorized to approve a curriculum.
\n\nThe individ ual designated as owner of a given curriculum should be someone who knows enough about specific roles in their organization. Curricula for GMP-regul ated tasks that the user performs directly require the inclusion of assess ments (knowledge or skill).
\n\nLearning Management Systems (LMSs) are important tools for assuring and demonstrating that Pharma employees maintain their training\, and the ir GMP compliance\, up to date. They often boast great functionality but a lso have limitations that must be overcome for a Pharma company to use the m effectively. An area that is not understood well is the development of t raining curricula in these systems\, which presents its own unique challen ges and takes far more time to implement than is commonly thought. In addi tion\, many employees have these responsibilities in addition to others no t necessarily related to training and do not have the luxury of time to cr eate and maintain a complex array of curricula.
\n\nAGENDA
\n\nLecture 1 (90 Mins): \;Introduction to P harma curricula - basic premise\, regulatory requirements\, knowledge chec k
\n\nLecture 2 (90 Mins): \;Components of Pharma curricula - core curricula\, job-specific curricula\, modules\, knowledge check
\n\nLecture 3 (90 Mins): \;
Lecture 4 (90 Mins): \;Hands-on activities for basic c urriculum and module setup outside of the LMS (conceptual)
\n\ nLecture 1 (90 Mins): \; Learning Management Systems (LMSs) and their relation to curricula
\n\nLecture 2 (90 Mins): \;LMS functionality ( employee information\, training course entry\, training completion entry) with demos and hands-on activities
\n\nLecture 3 (9 0 Mins): \;Processes for curriculum revisions: regulatory requ irements\, LMS-related complications and how to manage these
\ n\nLecture 4 (90 Mins): \;Course review and knowled ge assessment
\n\nSPEAKER
\n\n\nMichael Esposito< /strong> \;has over 30 years experience in the pharmaceutical industry and 17 years experience in GMP training and document management. He has w orked for Wyeth Pharmaceuticals\, Pfizer and Johnson &\; Johnson'\;s McNeil Consumer Healthcare Division in a variety of areas including Packa ging\, project administration\, Quality Assurance\, Government Contracts\, translations\, systems training\, and international operations. He collab orated in the development and implementation of the training portion of th e Consent Decree workplan for McNeil and revised their introductory GMP co urse. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence and is fully fluent in Span ish. His areas of interest include systems training\, training effectivene ss\, post-training user support\, process improvement\, and sustainable pa ckaging.
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\n SUMMARY:Learning Management Systems (LMS) (ntz) A BEGIN:VALARM ACTION:DISPLAY TRIGGER:-PT1H SUMMARY:Learning Management Systems (LMS) (ntz) A END:VALARM END:VEVENT END:VCALENDAR