A Standard Operating Procedure (SOP) or a set of them is a sine qua non for organizations in the regulated industries. Yet, a lion’s share of the deficiencies that get detected during the FDA’s inspectional observations of organizations relates to problems in the SOP, for which these organizations get hauled up for enforcement actions.
However, the irony is that the blame for this situation lies with the FDA: while it mandates the need for SOPs among companies in the regulated industries, it does not offer clear-cut guidelines on the right means to write, maintain, and update SOPs.
It is mainly because of the absence of these guidelines that many organizations come up with SOPs that fail to meet regulatory compliance guidelines. The most common areas in which they falter are the manner of their writing, communication, monitoring and enforcement. The SOPs that most organizations write either fall short of the details or miss the tools for ensuring compliance with the SOPs. Most of these SOPs contain errors that end up getting noticed only during an audit.
A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show the proper ways of writing SOPs in a manner that makes it easy for companies to maintain and update these and to also avoid punitive actions from the FDA. The speaker at this webinar is Todd B. Graham, a clinical laboratory scientist for a large hospital system in the New York Tri-State Area. Please register for this 90-minute webinar by visiting http://write.news/compliance_SOP
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At this session on quick ways to learn Standard Operating Procedure, Todd will explain a set of guidelines that will educate the participants on how to write SOPs and work instructions for FDA-regulated organizations. This will help participants with:
- Becoming familiar with the basics of how to generate a great SOP
- Understanding how to remain compliant and yet not restrict the course of action
- Gaining knowledge of how to maintain the compliance over the course of the SOP lifetime.
At this highly valuable, well-rounded learning on the proper ways of writing SOPs and work instructions that befit FDA-regulated organizations; Todd will cover the following areas:
- Record compliance with examples
- What are SOPs?
- Why are they important?
- What are their benefits?
- What are their limitations?
- Important types of SOPs
- Minimum number for SOPs, topics, and examples
- SOPs and guidelines
Steps to develop an SOP
- Process mapping
- Authoring
- Formatting and language
- Editing
- Authorizing
- Training
- Implementation
- Revision / archiving (version control)
- An SOP example and template
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About the speaker: In his role as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities, Todd has helped organizations improve sample workflow and laboratory quality and reduce sample turnaround time. Through his work, he has also helped expand laboratory services to vulnerable health populations in the New York area. Another of his pursuits has been to offer outreach services to the local community by serving as a mentor to not only students training in clinical laboratory science, but also the scientific community, which he has done by serving as a technical resource for his peers in the laboratory.
Compliance4all 