Training Agenda
3 Day SOP Writing Course Agenda
Day 1: SOP Foundations & Effective Writing
Understand the purpose of SOPs and learn how to write clear, audience-focused procedures.
Review of Learning Objectives
- Course goals and expected learning outcomes
Purpose of Standard Operating Procedures
- Mandates for SOP documentation set forth by regulators, including FDA, ISO, and other governing bodies
How to Develop / Write Effective Written Correspondence
- Use of specific words when writing instructions
How to Write to the Audience
- Organize and deliver information based on the message
- Understand how to structure SOPs
Day 2: Grammar, Team Writing & SOP Practice
Build confidence in writing, revising, and developing SOPs collaboratively.
Understand the Innate Structures of English Grammar
- Create grammatically sound passages
- Understand how active and passive voices work
- Choose the most appropriate voice for the type of writing being done
Team Writing SOPs
- Advantages
- Creating buy in
- Training the Trainer
SOP Writing for Participants
- Participants will be given a topic and asked to write a short SOP
- Participants will discuss how they would approach SOP writing with a team
Reviewing and Revising SOPs
- Practice reviewing SOP content for clarity, structure, and usability
- Revise SOP language to support compliance and consistent execution
Understanding Writing Patterns
- Knowing the answers to questions about the English language
Confidence in Writing and Revising SOPs
- Practice writing and revising
Day 3: SOP Control, Enforcement & Documentation Practices
Learn how SOPs are controlled, trained, enforced, and supported by good documentation practices.
SOP Distribution
- Routing SOPs for approval
- Role of document control
- Training
- Effective dates
Enforcing SOPs
- Management’s role
- Quality Assurance’s role
- Personnel’s role
Good Documentation Practices
- General requirements
- GDP basics
- Record control
- Modifying records in a compliant manner
- Attachments and printouts
- Examples of documentation errors with attendee participation
Final Questions / Answers / Comments
- Open discussion and closing review
Assessment Opportunity
- Opportunity to assess understanding and apply course concepts
Writing Effective Standard Operating Procedures (SOPs) for Regulatory Compliance and Operational Excellence Course Description
Standard Operating Procedures (SOPs) are essential documents in regulated industries such as pharmaceuticals, biotechnology, medical devices, and healthcare. They provide step-by-step instructions for performing critical processes to ensure consistency, quality, and compliance. This course is designed to equip participants with the necessary skills and knowledge to develop clear, concise, and effective SOPs that meet regulatory requirements and enhance operational efficiency.
Participants will learn how to organize and deliver information for the intended audience and purpose. They will learn how to write clear and readable documents, and how to revise and refine their own and others’ writing.
This 15-hour accredited training will cover practical guidance on the purpose of Standard Operating Procedures as well as the requirements from regulators for SOPs. Guidance will be provided on how to write from the reader’s perspective, and how to structure SOPs so that they are accurate, concise, and to the point. Tips on formatting SOPs will be given. Examples of current FDA finding for SOP deficiencies will be given and discussed. Practical and effective SOPs templates will be shared with the participants. This course will provide guidance for team writing of SOPs, as well as best practices for SOP distribution. Good documentation practices will also be discussed.
Who Should Attend?
This course is intended for all personnel directly involved in the development of standard operating procedures including those responsible for writing validation protocols or execution activities. Beginning or seasoned operational personnel who will participate in team writing and individuals in management who communicate with regulatory agency inspectors will also benefit from attending this course.
There are no prerequisites for attending, but a basic knowledge of good manufacturing practices is helpful.
The course will be especially beneficial to:
- Quality managers, engineers and auditors
- Quality Assurance and Control professionals
- Process and production supervisors
- Validation engineers
Benefits: Upon completion of this course, participants will possess the skills and confidence to develop SOPs that meet regulatory requirements, enhance operational efficiency, and promote a culture of quality and compliance within their organizations. They will be equipped with practical tools and techniques to effectively manage SOPs throughout their lifecycle, from creation to implementation and continuous improvement.
What’s Included in Your Registration
Each participant will receive:
- Downloadable presentation slides for easy reference
- Certificate of participation to document training completion
- Interactive Q&A session with the instructor
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Free handouts and templates on writing effective SOPs for regulatory compliance and operational excellence
Know Your Faculty
Course Speaker
Faculty
Kelly Thomas
Kelly Thomas is a seasoned Quality Assurance and Regulatory Compliance expert with over 30 years of experience in the pharmaceutical, biotechnology, API, and medical device industries. Her expertise includes FDA cGMP compliance, Quality Management Systems (QMS), process validation, technology transfer, supplier quality management, regulatory inspections, and global quality systems.
Kelly has successfully led FDA, EMA, Health Canada, ANVISA, and other international regulatory inspections, supporting API, biologics, sterile injectable, oral solid dosage (OSD), medical device, and combination product manufacturing. She is recognized for strengthening quality systems, driving inspection readiness, implementing Lean Six Sigma initiatives, and helping organizations achieve regulatory compliance while ensuring product quality and patient safety.
