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
- Recognize the concepts of sterility and sterility assurance level (SAL).
- Identify the advantages and disadvantages of using ethylene oxide.
- Summarize the regulatory evolution of the validation concept.
- Define validation from a regulatory and ISO perspective.
- Summarize the importance of validation, understand when to validate, and determine what needs to be validated based on product impact.
- Be able to differentiate between verification and validation.
- Be able to conduct equipment qualification.
- Identify critical parameters of EtO sterilization validation and draft a protocol.
- Recognize what documentation is required to set up a validation program.
- Understand how to maintain a validated state via continuous monitoring.
- Integrate risk-based management into the validation process.
- Regulatory Overview: the concepts of sterility/validation, why, what, when to validate.
- How to Validate: IQ,OQ,PQ, protocols, critical parameters, FDA inspections, 510(k) submissions requirements.
- Activity: Design a process validation protocol.
- Other Topics: when to validate, risk management, validation program, validation documentation, maintaining a validated state.
- Attendance 95% or above
- Acheive 95% on class activities and quiz questions.