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Certification in SOP management

weekend

Eligibility: Any HR professional

Duration: 55 Hrs

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Course Summary

Standard operating procedures (SOPs) play a crucial compliance role with regulations. It is therefore essential that they are well written and easy to use. If SOPs are not followed correctly, the validity of data generated is compromised, leading to inspection findings and non-compliance issues which could lead to delays in bringing a drug/device to market. This interactive SOP course has been specifically designed to help you develop the skills to write and produce the content of SOPs using a best practice process including process mapping, review and implement SOPs and ensure you comply in a regulated environment. You will come away with the confidence to use a best practice process to write, update and implement effective SOPs.

Course Content:

·         Procedure VS process

·         What is SOP

·         SOP VS Process.

·         Why SOP is necessary.

·         What is the benefit of SOP

·         When are SOPs needed and why?

·         The difference between SOPs, policy documents, work instructions and local guidance

·         Determine the scope, roles and responsibilities associated with SOPs

·         Identify the essential structure of SOPs

·         Share best practice: what makes a good SOP?

·         Identify who should write, review and authorise SOPs

·         Current thinking in writing SOPs and an example of a good SOP

·         Application of process mapping for writing SOPs

·         Example of a best practice SOP

·         Translate the flow of operations into the document

·         Write SOPs that are sufficiently detailed, but not restrictive and limiting

·         Understand the target audience and account for end users’ needs

·         Tips for how to write the content, format, style and presentation

·         Defining SOP content using mind-mapping and process-mapping/flow-charting

·         Review and approval processes for SOPs

·         Handling updates – when should SOPs be updated and how?

·         Distribution, version control

·         SOP training

·         How to maximise end-user compliance

·         Exercise: write an SOP using best practice methodology

·         What needs to be included for compliance in GxP areas?

·         Current regulatory trends

·         Tips for what auditors and inspectors look for when they review SOPs

 

Intec and advantage from the course :

  • Breaking down a process, to be able to write a procedure to describe it.
  • The rules of writing a procedure.
  • Writing 1-page procedures
  • Matching the procedure to a target audience.
  • The difference between an SOP and work instruction.
  • You'll know why NOT to write procedures, and what alternatives you can use.
  • How to gain cooperation among employees, by simply using a procedure.