Write & enforce effective sops

Introduction

Writing and enforcing effective standard operating procedures (SOPs) can be challenging. Any professional working in a regulated industry—from quality assurance techs to R&D, IT, and manufacturing managers—must know how to organize and deliver technical information effectively. Your SOPs and work instructions must be clear, concise, and targeted at an intended audience for an intended purpose if you want readers to actually read and understand how to perform their job functions well and safely.

Why should you attend?

Learn how to write successful and compliant SOPs with the help of quality assurance consultant Joy McElroy. She will show you how to produce well-written, succinct, readable SOPs that support the specific activities of your department, unit, or business. And she’ll explain the SOP mandates set forth by the Food and Drug Administration (FDA) and other regulators. You’ll get an in-depth tutorial that includes tips for revising your own and others’ writing, correcting grammar, structuring the SOP appropriately, and adjusting your language for a particular audience and effect.

After attending this live webinar, you will be well prepared to produce effective SOPs and work instructions that meet federal standards and keep workers productive and safe. Plus, you’ll be able to use your newly refined skills to write and revise almost any kind of critical project document.

Learning Objectives

• Apply documentation mandates set forth by the FDA, the International Organization for Standardization, and other regulators
• Produce effective written correspondence
• Assess and write for an audience

Areas covered in the Webinar

• Organize and deliver information based on the message
• Structure SOPs
• Create grammatically sound passages
• Select active and passive voices appropriately and for effect

Who Will Benefit?

• Scientists, engineers, and technicians in research and development
• Quality assurance professionals
• Engineering/validation professionals
• Information technology professionals
• Manufacturing professionals
• Administrative staff who prepare documentation to support manufacturing operations
• Anyone who wants an in-depth, comprehensive overview of the structure of the language and writing used in the reporting that the industry requires

Speaker : Joy McElroy

Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing environmental monitoring and sterility testing after earning a degree in zoology at North Carolina State University. She moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy 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, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, she has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Joy’s knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. She specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Joy 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.

Time: 01:00 PM EST| 10:00 AM PST | Duration: 60 Minutes