Online Seminar 2019 - Use Code EBJUL19 & Get 10% Off

Overview
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.
Session Highlights
• 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 trainingWhat 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
Why attendees should register
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 authorTo 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
To explore the connection between SOPs and job performance, and measure retention of SOP content at the training stage
Who Will Benefit
Documentation Specialist
Documentation Manager
Technical Writer
Trainer
Training Manager
Quality Assurance Specialist
Quality Assurance Manager
Instructor Profile
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.