Managing Standard Operating Procedures (SOPs) in the FDA Regulated Environment

Part of the GMP Laboratory Control Professional Certification Program

Duration: 90 Minutes
Course Instructor

Danielle DeLucy, M.S.

$ 195
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. In many cases, this sometimes leads to subpar documents that come to light during a regulatory inspection.

In this accredited training you will learn how to write, organize, and maintain SOPs and train personnel in a method that will ensure compliance in a way that is reproducible and easy to follow.

This training will cover such topics as:

  • Why written procedures are beneficial
  • FDA expectations for written documents and Regulatory Requirements
  • Developing an effective review and approval process compliant with regulatory requirements
  • How to implement a training program for document creation and review
  • A system for the control, archival, and disposal of written procedures.

Upon completion of this course, you will be able to:

  • Describe the steps in formatting SOPs
  • List elements to include other than the procedure
  • Explain how to write effective but efficient documents
  • Describe the roles and responsibilities of authors and reviewers of SOPs
  • Define roles in SOPs for supervisors and operators

This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program. Attend this course as part of the certification process or as a stand-along course for personal career advancement and training.

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This training has been designed to benefit professionals in the FDA regulated industries including pharmaceutical, medical device, biotechnology, cosmetic and food. It will be especially valuable to those Directors, Managers, Professionals, Technical writers and General staff charged with the responsibility for creating, reviewing and approving written standard operating procedures and instructions.

Course Instructor


Danielle DeLucy, M.S.

Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, M.S.’s Courses
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