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Writing and Enforcing Effective Standard Operating Procedures (SOP) and Work Instructions

Duration : 90 Minutes

Joy L. McElroy,

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more

This training program will guide attendees in writing effective Standard Operating Procedures and Work Instructions. It will also discuss how to assess and write to the audience and how to review and revise SOPs and Work Instructions.

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work. This webinar will help you structure your QMS and develop accurate, clear, unambiguous SOPs.

Course Objectives:

• Understand the mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
• Understand QMS structure
• Know how to produce effective written correspondence
• Understand how to assess and write to the audience
• Know how to organize and deliver information based on the message
• Understand how to structure SOPs
• Know how to review and revise SOPs and Work Instructions
• Understand common problems and areas for improvement

Why Should You Attend:

This course will address how to write effective Standard Operating Procedures and Work Instructions in support of your company's activities. Attendees 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 the documents.

Anyone who wants a comprehensive overview of the structure of the language and writing for reporting that the industry requires will find this webinar helpful. You’ll learn how to effectively write SOPs that remove ambiguity for employees so that procedures can be followed exactly the same way, every time.

Course Outline:

• FDA and NB expectations for SOPs
• Lessons learned from 483s and warning letters
• Common problems with SOPs
• How to structure your QMS and SOPs
• How to outline and format your SOPs
• Using process maps to make procedures clear
• Using diagrams and visuals
• Maintaining and controlling SOPs
• Ensuring adequate training to your SOPs
• Assessing and writing to the audience to produce effective written SOPs and Work Instructions
• Reviewing and revising documents

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Scientists, engineers, and technicians in research and development
• Quality assurance (QA)
• Engineering/validation
• Information technology (IT)
• Manufacturing
• Operations professionals
• Document Control Specialists
• Quality and Compliance Specialists
• Internal Auditors and Managers
• Training Specialists
• CAPA Specialists
• Administrative staff who prepare documentation in support of manufacturing operations

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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Subject : Writing and Enforcing Effective Standard Operating Procedures (SOP) and Work Instructions

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