Dissolution testing mimics the behavior of pharmaceuticals in the body and is an important part of quality control, determination as to whether drugs are performing to regulatory standards, and decisions around pharmaceutical excipients.
Performance of dissolution qualification and the results obtained are key concerns for the FDA and other regulatory bodies. Poor performance or even non performance may lead to out-of-spec (OOS) test results, an FDA Form 483 observation, or even a warning letter from the FDA.
 
In this webinar we are focusing on challenges faced in the laboratory including computer system validation of UV/Vis systems used in the dissolution process (what is required and why), regulatory updates and best practices of dissolution testing in today’s regulatory environment.

• Analytical tools to make your life in the lab more efficient
• Best practices for the Pharma laboratory
• Dissolution Qualification: USP Apparatus
• USP PVT vs Mechanical Qualification
• New Updates from USP and EP texts
• CSV and Data Integrity’s role supporting dissolution 
• UV/-Vis technique as part of Dissolution Testing Apparatus

• QA/QC Scientists
• QA/QC Managers
• Head of Quality Assurance/Quality Control
• CRO and CMO laboratories