Key Factors to Write an Effective Standard Operating Procedures (SOP) and Work Instructions (WI)

Duration: 180 Minutes
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This course addresses how to write effective SOPs, and work instructions in support of your company's activities. This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The instructor will also help to differentiate Work Instructions from Standard operating procedures.
How to Write SOPs and Work Instructions
Instructor: Joy McElroy
Product ID: 508758
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. 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.

Objectives of the Presentation
  • Food and Drug Administration (FDA), the International Organization for Standardization (ISO) requirements for documentation
  • Effective written SOPs and work instructions
  • Properties of an effective work instruction
  • Properties of an effective Standard operating procedure
  • The differences between work instructions and Standard operating procedures
  • How the active and passive voices work
  • Reviewing and revising documents
  • Writing patterns
  • Understand common problems and areas for improvement
Why Should you Attend
You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable SOPs and Work Instructions, and how to revise and refine your own and others' writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues, and specific audiences.

You will also learn how to implement good documentation practices within your SOPs and Work Instructions. 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
  • 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
  • Lessons learned from 483s and warning letters
  • Assessing and writing to the audience to produce effective written SOPs and work instructions
  • How the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing
  • Reviewing and revising documents
  • Writing patterns and knowing the answers to your questions about the English language
  • Ensuring adequate training to your SOPs
  • Using process maps, diagrams and visuals to make procedures clear
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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  • 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
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  • 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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