SOP Writing, Training and Compliance in the Pharmaceutical Industry

Areas Covered :

• Regulatory requirements for SOPs
  • Using process excellence tools to create a robust process and procedure
  • What commitments you make when you put your process in writing
  • Keeping training in mind while writing procedures
  • Consequences of noncompliance
• Define the parameters of an effective SOP
• How your foundation keeps subsequent steps from going awry
• Why poorly written procedures have a negative impact on production
  • What identifies a poorly written procedure
  • Compliance risks with ambiguity or excessive detail
• Interact with the SOP process owner/author to improve the writing of procedures
• Integrate the SOP effectively into the position curricula of employees
  • Relationship between SOPs and employees’ training curricula
  • Why the training department needs to be in the loop at the start of the SOP development process
• Retention of the content at the training stage
  • The implications of good training for successful SOP execution
  • Perform an ongoing assessment of knowledge retention of SOPs for continuous improvement
• Review of learning objectives