Health & care : SOP Writing, Training and Compliance in the Pharmaceutical Industry

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 the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations.

Why you should Attend:

To improve the writing of SOPs for more effective training and reduction of errors. To understand the regulatory implications of what is written in an SOP. 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.

Areas Covered in the Session:

• 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
  • Avoid pitfalls in revising SOPs
• Review of learning objectives

Learning Objectives:

• Articulate what constitutes a Pharma curriculum
• Distinguish a true Pharma curriculum from common misconceptions regarding Pharma curricula
• Work effectively with peers and management to set up curricula for their organizations
• Obtain details of employees’ job functions that are necessary for setting up curricula
• Create curricula that are intuitive for employees
• Demonstrate training compliance to auditors through the effective use of curricula

• Pharmaceutical industry, particularly those areas that develop SOPs for the manufacturing or quality monitoring of pharmaceutical products, as well as Information Technology (IT)

Certificate of completion

Digital certificate - Included