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, or through other grant and scholarship opportunities.

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Course Details & Registration Information

Course
FDA Audit Preparation
Name
SEF-3001KI1
Available Classes
    Section Location Begin Date End Date Instructor Price Seats Available/Total Seats
237307 Face-to-Face Online Instruction 02/11/2021 02/12/2021 R. Fernandez $270.00 20/20
Description Course Outline Requirements Intended Audience More Details
Intended Audience
Team Leaders and Supervisors, Regulatory Personnel, Quality Control Personnel, Quality Assurance Personnel, Manufacturing Technicians, Administrative Personnel (scribes), Maintenance/Engineers
Description
This course is designed to help in creating an environment of preparedness and a culture of quality assurance by raising the awareness of FDA compliance in regulated facilities. Maintaining current knowledge of preparation steps, do’s and don’ts, documentation completeness and thoroughness, and an understanding of real-time preparedness can help to reduce employee stress during an actual audit. This course equips professionals who will experience FDA audits to maintain compliance by following and documenting in accordance with CGMP.
Course Objectives
  1. Attain an understanding of the importance of both internal and external audits.
  2. Describe the relationship between FDA auditing activities and CGMP compliance through the Code of Federal Regulations (CFR) for pharmaceuticals.
  3. Identify audit findings from real company inspections.
  4. Explain do’s and don’ts for FDA audits.
  5. Distinguish the roles of company representatives during an audit.
  6. Relate the importance of proper documentation to provide evidence of compliance with CGMP.
  7. Perform an audit of a document used in the biopharma industry.
Outline of Instruction
  1. Reasons for and the importance of audits
  2. What is fair game during an audit
  3. Preparing for an audit
  4. Do’s and don’ts
  5. Company responsibilities
  6. Preparation activities and documentation
  7. Review of 483s and warning letters
  8. Things to know about an FDA audit
  9. What to expect
  10. Auditor roles & rights
  11. Auditor responsibilities
  12. Review of sample documentation
Contact Hours
8
CEU's
0.8
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Provided by BioNetwork
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 100%
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
Team Leaders and Supervisors, Regulatory Personnel, Quality Control Personnel, Quality Assurance Personnel, Manufacturing Technicians, Administrative Personnel (scribes), Maintenance/Engineers
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
  • Team Leaders and Supervisors
  • Regulatory Personnel
  • Quality Control Personnel
  • Quality Assurance Personnel
  • Manufacturing Technicians
  • Administrative Personnel (scribes)
  • Maintenance/Engineers
Related Courses
  • Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
  • Medical Devices, CGMPs and ISO Overview - SEF-414CL
  • Good Documentation Practices and Data Integrity - SEF-211CL
Course Contact Information
Bionetwork Manager