PTI - international

I. Identify GxP Requirements Related to SOPs

• Examine relevant aspects of GMP, GCP and GLP regulations
• Review the FDA's expectations for SOPs
• Understand current industry practice
• Determine the significance and the requirements for SOP training

Exercise: Identify Participants' Background and Experience with SOPs

II. Determine the Role of SOPs within a Comprehensive Documentation System

• Define SOPs and their objectives
• Acknowledge why SOPs are needed, who uses them, and how they are used
• Determine why different SOP types are needed
• Explain how and why SOPs should be integrated with other documents
• Explain the impact of corporate and site policies and guidelines

III. Establish and Define Your SOP Format

• List the typical components of the SOP template
• Acknowledge the special headings required for work functions
• Determine how to describe procedural contents of SOPs

Exercise: Write an SOP Based on a Given Regulation

IV. Apply Best Practice Writing Techniques for Your SOPs

• Outline the use of active voice vs. inactive voice in SOP writing
• Use techniques for minimizing wording in SOPs
• Critique useful tools in constructing meaningful sentences
• Identify common pitfalls in writing
• Write in simple, clear language
• Use techniques and visual aids to enhance SOP readability and compliance

Exercise: Write an SOP on a Given Topic