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 12-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.
This live training seminar includes the following for each registered attendee:
- A copy of the presentation slides by download
- A certificate of participation for attendee training records
- Q/A Session
- Free Handouts on Writing Effective Standard Operating Procedures (SOPs) for Regulatory Compliance and Operational Excellence
How to Attend:
All WCS Seminar live training programs audio and visuals are delivered via Go to Webinar with a basic system requirement of a computer with internet access. You do not require a Go to Webinar account to join WCS Seminar live training courses, participants receive an email invitation that provides the access you need to join the meeting.
Know Your Faculty
Kelly Thomas, Vice President at America’s Quality Operations, has 20 years of hands-on experience in the industry. She has worked with reputed facilities like FDA, EMEA, IMB, JP, and Health Canada. Her core expertise includes computer system validation, equipment process validation, and facilities validation. In addition, she will guide you on implementing a robust quality system, evaluating the KPIs of the facility, and executing high-quality management.
