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.
Training Agenda
Review of Learning Objectives
Purpose of Standard Operating Procedures
- Mandates for SOP documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
How to Develop/Write effective written correspondence
- Use of specific words when writing instruction
How to write to the audience
- Know how to organize and deliver information based on the message
- Understand how to structure SOPs
Understand the innate structures of English grammar
- How to create grammatically sound passages
- How the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing
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, they will have time to discuss how they would approach the writing with a team.
Reviewing and Revising SOPs
Final Questions/Comments/ Discussion
Understanding writing Patterns
- Knowing the answers to questions about the English language
Confidence in writing and revising SOPs
- Practice writing and revising
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
Assessment Opportunity
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
- Free handouts and templates on writing effective SOPs for regulatory compliance and operational excellence
Hear from Our Learners: Real Success Stories
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"This was one of the most practical and engaging courses I’ve taken. The instructor broke down complex concepts into clear, actionable steps, and the templates provided were immediately useful for my team. I now feel confident writing SOPs that are not only compliant but also easy for staff to follow. Highly recommended for anyone responsible for process documentation."
— Quality Assurance Manager, Healthcare Industry
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"This training was exactly what I needed. The focus on regulatory compliance and document control gave me confidence that our SOPs will stand up to audits. The practical examples and templates saved us hours of work."
--- Compliance Officer, Medical Device Industry
✅ Frequently Asked Questions (FAQ)
1. Who should attend this course?
This course is designed for managers, team leads, compliance officers, quality assurance staff, business analysts, and anyone responsible for writing, reviewing, or maintaining SOPs and process documents.
2. Do I need prior experience writing SOPs?
No prior experience is required. The training is suitable for beginners as well as experienced professionals who want to refine their skills and learn best practices.
3. How is the training delivered?
This is a live, interactive seminar that includes instructor-led sessions, Q&A, group discussions, and practical exercises.
4. Will I receive any materials after the course?
Yes. Each participant receives downloadable presentation slides, free handouts and templates, and a certificate of participation.
5. How long is the course?
The seminar typically runs as a 3-day intensive program
6. Will there be an opportunity to ask questions?
Absolutely. The live Q&A session is built into the seminar so you can get answers to specific challenges in your organization.
Know Your Faculty
Kelly Thomas (Head Of Quality Assurance, North America) 20 + years exp.
Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams. .
