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.
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 webinar 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
Course Content
Review of Learning Objectives
Course Provider
Ms Kelly Thomas,
Vice President ,
Stallergenes GreerMs. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
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
