Writing Effective sops for FDA and CLIA Regulated Companies

Joy L. McElroy
Jul 25, 2019 - 01:00 PM EDT
Starting at

$249


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Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 42. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or seemingly impossible. This often leads to regulatory errors that come to light during a FDA audit. Every FDA and CLIA inspection starts with a review of SOPs. Thirty to forty percent (30%-40%) of adverse inspection issues are a result of poorly written SOPs.

Course Objective

This course will show you how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. You will also gain a strategic view of how SOPs help streamline operations and create efficiencies, while ensuring regulatory compliance. This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.


Course Outline

  • SOPs and their relation to the regulations
  • SOPs as part of the company’s regulatory infrastructure
  • Best Practices for writing SOPs to ensure conciseness, efficiency and ease of use Risk Based approach for writing SOPs
  • Training on SOPs
  • Tools for tracking SOPs life-cycle and when validation is required
  • What an inspector looks for in SOPs during an inspection


Target Audience

  • CEOs
  • Regulatory VPs / Quality VPs / IT VPs
  • Regulatory Affairs Professionals
  • Quality Managers
  • Quality Engineers
  • Small Business Owners
  • GxP Personnel
  • Consultants

Webinar Events
Attend Live Webinar
Jul 25, 2019 - 01:00 PM EDT

Duration: 60 Minutes

Single Attendee


Group of 3 to 5


Group of 6 to 10 + DVD-USB


Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Joy L. McElroy,

Upon earning a degree in Zoology at North Carolina State University, Joy 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 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, Joy 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. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy 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.


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