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This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.

Why should you Attend:

This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests.

Attend this webinar to understand the differences and the proper methods to meet the guidelines. It is important to understand that measuring quality is essential to assessing quality. The measurement of processes and the outcomes is the only way to truly assess quality.

Areas Covered in the Seminar:

This webinar on issue detection and escalation in clinical trial settings will review the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.

Why Should You Attend:

This webinar on Trial Master File (TMF) for clinical research sites will show how you can create an FDA compliant TMF to ensure that it will pass inspection by FDA investigators and QA Auditors.

Why Should You Attend: Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.

The FDA frequently states that if compliance isn't documented, it didn't happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control.