The document presents a guide on writing effective Standard Operating Procedures (SOPs) and covers key topics such as the definition of SOPs, their importance, and the necessary components they should include. It explains how SOPs serve as formal documents that provide clear, step-by-step instructions for adhering to established practices, particularly in regulated environments. The presentation also includes an agenda and additional resources for more detailed information.

1. Writing Effective SOP’s
Presenter
Angela Bazigos
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Learn Ways To Write, Organize And Maintain Standard Operating Procedures And
Teach Personnel The Methods That Will Ensure Compliance In A Manner That
Will Be Reproducible, Concise And Easy To Follow!

2. Agenda
 What is an SOP
 Agencies Requiring SOPs
 Why use SOPs
 SOPs vs Regulations
 SOP Issues & Related Citations
 The Auditor’s Cheat Sheet
 The SOP Lifecycle
 SOPs Every Company Should Have
 Sections Every SOP Should Have
 Summary
 References
 Q&A
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3. What is an SOP?
 Formal document that describes how an individual or
organizations performs a task and documents the
performance of that task
 Provides step by step set of instructions to the person(s)
performing a task
 Specific enough to be clear and flexible enough to be
useful
 Defines expected practices in industry where quality
standards exist
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4. What is an SOP (Cont’d)
 Big-Picture Documents for Regulated Environment
 Strategic / Describe WHAT
 Need to go through SOP Process
 Typical Names: Policy, SOP
 May be Global but will impact local SOPs
 May not be trained on it despite it impacting local SOPs
 How-To Documents for Regulated Environment
 Procedural / Describe HOW
 Need to go through SOP Process
 Typical Names: SOP, Process, Procedure, Work Instruction
 Local
 How-To Documents for Non-Regulated Env (e.g. Research)
 Does not need to go through SOP Process – Out of Scope
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5. To see the complete presentation check the
below link:
http://www.audioeducator.com/pharma-biotech/writing-effective-sops-fda-
compliance-12-15-2015.html