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.


Course Details & Registration Information

Course
Validation of Upstream and Downstream Processing
Name
SEF-79854
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Description
Learn the process for validation of automated equipment and process control systems typically found in the biomanufacturing or pharmaceutical facilities using GAMP 5 and other guidelines. Highly interactive activities including discussion of case studies and hands-on development of documentation are provided.
Course Objectives
  1. Determine risk assessments and test acceptance criteria based on guidance documents, the validation life cycle, requirements, and system specification documents.
  2. Develop test documentation for automated equipment and process control systems validation.
  3. Demonstrate capabilities in testing and accurately reporting discrepancies/deviations and conclusions to meet regulatory audit expectations including traceability of testing performed as needed for audits.
Outline of Instruction
  1. Types of automated equipment/process control systems
  2. CGMPs and regulatory requirements
  3. Industry guidance documents/ documentation requirements
  4. Part 11- Electronic Records/Signatures
  5. GAMP 5 Life Cycle
  6. Risk and Impact Assessments
  7. Validation test plan and development
  8. Creating validation documentation
  9. Handling discrepancies/deviations during testing
  10. Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  11. Maintaining the validated state
Contact Hours
16
CEU's
1.6
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Some validation experience or Fundamentals of Validation (SEF-165CL) is preferred.
Text and Supplies Needed
Course materials will be provided.
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 90% or above
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
Related Courses
  • Introduction to Computer Validation - SEF-79534
  • Computer Application Validation - SEF-79844
  • Fundamentals of Validation - SEF-165CL
Course Contact Information