Effective Ways to Prepare a Standard Operating Procedure (SOP) : Writing, Updating and Maintaining Compliance

Wednesday, March 20, 2019   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 60 Minutes          


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  Duration: 60 Minutes  


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This webinar will instruct the participants how to write, maintain, and update SOPs to ensure compliance, Also this online training will provide guidelines on how to write standard operating procedures and work instructions for FDA-regulated organizations, Also you will become familiar with the basics of how to generate a great SOP.

Todd B. Graham   Product Id : 502386
  Instructor : Todd B. Graham

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Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there are no guidelines available by regulatory bodies on how to write, maintain, and update SOPs.

Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit.

Technically, all FDA inspections include an SOP review and it is very important to have them designed such that they are easy to maintain and update.

This webinar will instruct the participants how to write, maintain, and update SOPs to ensure compliance.

Why should you Attend: A large number of FDA's inspectional observations can be traced back to deficiencies in SOPs at an organization.

SOPs are often inadequate, miss important elements, lack tools to increase compliance with the SOPs and, often are hard for the employees to understand them. They are frequently poorly written, communicated, monitored and enforced.

This webinar will provide guidelines on how to write standard operating procedures and work instructions for FDA-regulated organizations.

  • You will become familiar with the basics of how to generate a great SOP
  • How to remain compliant and yet not restrict the course of action
  • How to maintain the compliance over the course of the SOP life time

Areas Covered in the Session:
  • 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

Who Will Benefit:
  • Anybody who works in a regulated environment (manufacturing, R&D, labs, Lab managers, Clinical trial personnel)
  • Legal, Regulatory Authorities and all Other Professionals who want to know More about Inspection of SOPs
  • Drug Research and Development Managers and Personnel
  • Clinical Research Associates
  • Clinical Research Archiving and Document Management Personnel
  • Quality Assurance Managers and Auditors
  • Clinical Development Managers and Personnel
  • Manufacturing
  • Pharmacovigilance
  • Laboratories
  • CROs
  • Project Management
  • Sponsors and Non-Commercial Sponsors
  • Sponsors who Have their Own Laboratories for Analyzing Clinical Trial Samples
  • Consultants
  • Laboratories Analyzing Samples from Clinical Trials
  • Regulatory Affairs
  • Clinical Trial Supply
  • Document Management
  • To those Departments who have SOPs

Speaker Profile
Todd B. Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities. During his time as a clinical laboratory scientist in his current role, he has improved sample workflow and improved laboratory quality and sample turnaround time while expanding laboratory services to vulnerable health populations in the New York area. He has also provided outreach to the local community by serving as a mentor to students training in clinical laboratory science, as well as the scientific community by serving as a technical resource for his peers in the laboratory.

Through his work as a consultant, he has worked to improve the spread of key technical information in a variety of mediums. Todd has written a number of market research reports used by Fortune 500 biotechnology firms in strategic planning, and led webinars on key quality issues that impact the biotechnology community. He has served R1 Research Level Universities by advising them on strategic technology transfer opportunities, and has been called upon as a key knowledge leader internationally for the biotechnology industry.

Todd Graham graduated in 2006 with a MA in Biology at Queens College (City University of New York) after conducting published research in Molecular Evolution in the laboratory of Dr. Stephane Boissinot. He graduated as a Dean’s List student and James Dickson Carr Scholar from Rutgers University in 2001 with a BS in Biotechnology, where he continues to mentor Biotechnology students. He is a member of the Society for Laboratory Automation and Screening. He is also licensed as a Clinical Laboratory Technologist in New York State and is certified in Molecular Diagnostics by the American Society for Clinical Pathology.

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