Biotechnology

Wake Tech offers a variety of non-degree, short classes and certificate training programs in the biotechnology field, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.

Financial assistance is available for some Biotechnology courses!

You may qualify for a scholarship through the WakeWorks Propel program!

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Course Details & Registration Information

Course
Writing Effective Standard Operating Procedures (SOPs)
Name
SEF-413CL
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Intended Audience
Biomanufacturing, Bioprocessing, Pharmaceutical, Medical Device, Cosmetics, and other FDA regulated industry sectors.
Description
Students will learn how to write an effective Standard Operating Procedure (SOP) as well as why these are a required and essential component of documentation systems in regulated industries. Discussion will include the functional areas in which SOPs are needed, the qualities that make them effective, and the importance of keeping these current. Students will learn how to structure an SOP and the content that should be included. Hands-on activities include reviewing and critiquing an SOP for completeness and effectiveness, as well as practice writing SOPs.
Course Objectives
  1. Explain the regulatory and business rationale for SOPs.
  2. Identify FDA expectations.
  3. Define at least 2 approaches for determining what SOPs are needed.
  4. Identify factors that support SOP efficacy.
  5. Distinguish between methods of presenting SOP content.
  6. Analyze the structure and content of an SOP for adherence to the principles of effective SOP construction.
  7. Create an SOP utilizing the principles learned in class.
  8. Understand how to keep their SOPs current.
Outline of Instruction
  1. Lecture - principles, philosophy, regulatory compliance.
  2. Examples - overview and analysis of SOP examples for effectiveness.
  3. Writing exercise - creation of an SOP per the principles discussed in class.
Contact Hours
8
CEU's
0.8
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
none
Text and Supplies Needed
Provided with course delivery
Clinical Site/Special Facilities
Classroom with projection capability
Requirements for Successful Completion of this Course
  1. Attendance 95% or above
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
Biomanufacturing, Bioprocessing, Pharmaceutical, Medical Device, Cosmetics, and other FDA regulated industry sectors.
Specific Industry or Business Support Needs
Quality, Manufacturing, Management
Industry or Job Titles Related to training Outcomes for Employment
  • Quality
  • Manufacturing
  • Management
Related Courses
  • Good Documentation Practices and Data Integrity - SEF-211CL
  • Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
Course Contact Information
Martha Orman