Description

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 a procedure's writing can positively or negatively impact 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 SOPs and training.

What you'll learn?

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 hurt training
  • What identifies a wrong procedure
  • Identify the appropriate level of detail for the 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 should attend?

• This course will benefit anyone who owns a process, is responsible for writing or reviewing procedures, and/or managing training in a GMP environment.
• Documentation Specialist
• Documentation Manager
• Technical Writer
• Trainer
• Training Manager
• Quality Assurance Specialist
• Quality Assurance Manager

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