Writing Effective SOPs and Training Curricula

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. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.

Why Should You Attend:

• 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, particularly those areas that develop SOPs for the manufacturing or quality monitoring of pharmaceutical products, as well as Information Technology (IT). 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.

Michael Esposito
Principal, TrainReach Consulting, LLC

Michael Esposito has over 30 years experience in the pharmaceutical industry and 23 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 organization Association for GXP Excellence (AGXPE) and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, product security, and sustainable packaging.