Best Practices of Writing SOPs

Why Should You Attend:

Attend this webinar to improve the writing of both SOPs and training materials for more effective training and reduction of errors. Through this interactive course, learn how you can:

• To learn the parameters of an effective SOP
• To distinguish a well-written SOP from a poorly written one
• 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 explore the connection between SOPs and job performance, and measure retention of SOP content at the training stage

Areas Covered in the Webinar:

• Regulatory requirements for SOPs - consequences for inadequate SOPs or failure to follow SOPs
• Define the parameters of an effective SOP – how your foundation keeps subsequent steps from going awry…preventing “garbage in”
• Why bad procedures have a negative impact on training
• What identifies a bad procedure
• Identify appropriate level of detail for document
• Interact with the SOP process owner/author to improve the writing of procedures
• Using process excellence tools to create a robust process and procedure
• Basics of grammar and style
• How the training department needs to be in the loop at the start of the SOP development process
• 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
• Review of learning objectives

Who Will Benefit:

This course will be of benefit to Pharmaceutical industry.This course will be of benefit to anyone who is an owner of a process, responsible for writing or reviewing procedures, and/or managing training in a GMP environment.

• QA/QC directors and managers
• Production
• Regulatory professionals
• Engineering
• R & D
• IT/ IS
• Management - essentially everyone in the organization who is tasked with creating or reviewing procedures

Michael Esposito
Principal, TrainReach Consulting, LLC

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.