Measuring SOP Effectiveness Across Training, Qualification, GMP Operations, and AI-assisted environments

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
• To adapt existing effectiveness methods to AI-related changes

_{AREAS COVERED:}

• Deciding the main objectives of the SOP
• Interact with the SOP process owner/author to improve the writing of procedures
• Using process excellence tools to create a robust process and procedure
• Communication between documentation and training while SOPs are being developed 
• What SOP writers and approvers need to keep in mind for retention of the content at the training stage
• Translate the SOP into effective curriculum development and training execution
• The implications of good training for successful SOP execution 
• How the SOP wording can be "translated" into language that is appropriate for learners if a presentation, computer-based training or classroom session is to be developed
• Perform an ongoing assessment of the knowledge retention of learners for continuous improvement                                                                                                    
  • Use several different methods
  • Take advantage of tools that already exist in your organization                                                                                                                                                          
• AI and its impact on production and compliance
• Review of learning objectives

_{WHO SHOULD ATTEND:}

• Quality Departments
• Production Departments
• IT Departments
• Documentation Control Leaders
• Manufacturing Departments
• Operations Departments
• Regulatory Affairs Departments
• R&D Departments
• Compliance Departments
• Management - essentially everyone in the organization who is tasked with creating or reviewing procedures

Course Director: MICHAEL ESPOSITO

Michael Esposito brings three decades of pharmaceutical industry experience and more than twenty years specializing in GMP training and document management. Having worked with Wyeth, Pfizer, and Johnson & Johnson’s McNeil division, he has led major training initiatives, including consent decree remediation programs, and is known for translating complex compliance expectations into practical operational practices.