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.
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.
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
SOP Distribution
- Routing SOPs for approval
- Role of document control
- Training
- Effective dates
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.
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.
Event Venue
Online
