Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...

Reinforcing core ASTM-based packaging validation methods for medical devices and their operational relevance.

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...

LC-MS/MS has been increasingly adopted by clinical laboratories due to the potential it has for increased sensitivity and specificity over more commonly used analytical techniques. However, ...

The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...

Simply put, orthogonal validation uses additional methods that provide very different selectivity to the primary method to confirm or refute a finding. All methods are independent approaches that can ...