The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

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

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

Learn how to navigate the regulatory landscape utilizing current method development technologies for impurity control in late-phase API manufacturing. This webinar will cover the method development ...

Since the introduction of Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP OES) in 1974, and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) in 1980, these techniques have ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...