Measuring SOP Effectiveness Across Training, Qualification, GMP Operations, and AI-assisted environments
Learn how to measure and improve SOP effectiveness across training, qualification, GMP operations, and AI-assisted environments — connecting documentation, compliance, and workforce performance.
Instructor
Michael Esposito
GMP Training & Document Management Specialist
What You'll Learn
About the event
About this event
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. There are opportunities to leverage these procedures to measure and improve training effectiveness and job performance. In this course you will learn the vital connection between the documentation, compliance, and training spheres, how to maximize this connection to improve the quality of both SOPs and training, and adapt existing methods to the rapid changes brought about by AI.
WHY YOU SHOULD ATTEND
To learn the parameters of an effective SOP; to define processes better by effective interaction with the SOP process owner and/or author; to integrate the SOP effectively into the position curricula of employees; to leverage the connection between SOPs and job performance; to employ various methods to measure retention of SOP content at the training stage; to use investigations and CAPAs to measure SOP effectiveness; and to adapt existing effectiveness methods to AI-related changes.
Code: FDB1285
Curriculum
Requirements
- Working in pharmaceutical, biotech, or other regulated manufacturing environments
- Applicable to quality, documentation, training, operations, and compliance professionals
Who Should Attend
Quality Departments, Production Departments, IT Departments, Documentation Control Leaders, Manufacturing Departments, Operations Departments, Regulatory Affairs Departments, R&D Departments, Compliance Departments, and Management — essentially everyone in the organization who is tasked with creating or reviewing procedures.
Areas Covered
Meet Your Instructor
Michael Esposito
GMP Training & Document Management Specialist
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 areas including Packaging, 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.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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