4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions

Why Should You Attend:

This course will addresses 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.

Learning 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
• 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

Areas Covered in the Webinar:

• 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
• 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
• Administrative staff who prepare documentation in support of manufacturing operations

Instructor Profile:

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. She then moved into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. From there she moved into auditing clinical and GMP laboratories, and manufacturing facilities, then into validation engineering.

Now with 14 years’ experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, auditing, and GMP and GLP training. She has written and executed equipment qualification and validation protocols for numerous companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis. Ms. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, Good Documentation Practices, and GMP and GLP training.

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