Writing Effective SOP’s for Quality Professionals: Best Practices for Life Science Companies

Duration: 75 Minutes
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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.
How to Write Effective Standard Operating Procedures
Instructor: Joy McElroy
Product ID: 504127
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.

Objectives of the Presentation
  • 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.

Areas Covered
  • 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
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
$375
Recorded Session for one participant
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Live Session - How it works
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  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Upon earning a degree in Zoology from North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.


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