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Posted by Paul Cobb on Tue, Mar 08, 2016

Changes to the FDA Routine Inspection Plan: Will This Help FDA?

In the clinical research industry, approvals for investigational products are not granted- they are earned. Increasing numbers of FDA early-intervention and routine inspections can increase the stress levels of everyone involved in clinical trials. Auditing can be looked at as a quality assurance process, and a way to prepare for inspections and approval by:

  • Identifying and addressing issues before the FDA finds them.
  • Preparing for Inspections by reviewing the BIMO checklists and knowing what to expect.
  • Proactively addressing compliance concerns through BIMO preparation audits.
  • Verifying that vendors are qualified to do their jobs.
  • Preparing the research team with mock inspections along with interviewing and coaching sessions.

Topics: Voluntary Audits, FDA, Medical Device Single Audit Plan, Routine Inspection Plan

Posted by John Lehmann on Wed, Mar 04, 2015

Will Voluntary Audits Help the FDA?

In the clinical research industry approvals for investigational products are not granted- they are earned. With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. Auditing can be looked at as a quality improvement process, and a way to prepare for inspections and approval by:

Topics: Voluntary Audits, FDA, Auditing

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