Danielle DeLucy, M.S.
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:
Upon completion of this course, you will be able to:
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.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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