According to FDA 820.3(z), “Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

As we have previously discussed, expert testimony is a critical aspect of the Patent Owner’s case-in-chief of an inter partes review (“IPR”) proceeding. In addition to retaining the right expert ...

Inaccurate or falsified financial records are bad for everyone. They are bad for investors deciding if a company is worth their money and bad for managers who make decisions based on what the accounts ...