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Validation procedures are part of the regulatory process in a laboratory setting. Understanding the basic principles and reasons for validation is important for laboratory compliance of regulations and eventually for patient diagnosis and treatments of diseases. A discussion of current trends and changes with the latest CAP checklist will be reviewed and future direction of where IHC validation may end up will be discussed.
1. Understanding of the basic principles and reasons for the validation process.
2. Describe historical perspective of past IHC validation requirements.
3. Discuss current trends and changes in validation requirements (CAP latest checklist).
4. Examine the future direction of where the IHC validation process may end up.