SOP Writing, Training and Compliance in the Pharmaceutical Industry 2018

Topics

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

Who should Attend

Attendees who are owners of a process, responsible for writing or reviewing procedures, and/or managing training in a GMP environment from pharmaceutical companies.