Inspection Readiness: What It Is, Why It Matters, and What You Need to Know to Be Prepared

Organizations must have inspection readiness since inspections can be unannounced or come at any time. Good Clinical Practice (GCP) inspectors use different approaches depending on the regulatory authorities for which they represent; however, all of them will verify the compliance status on GCP and other applicable regulations during the inspection.

Planning ahead to anticipate all processes are compliant means an organization is prepared for an inspection and able to create a solid corrective action and preventative action (CAPA) to minimize risk.

Watch this webinar where Ernesto Vera-Sanchez, MD, PhD, Vice President of GxP Consulting services at Allucent, discusses the ins and outs of preparing for regulatory authority inspections during a drug’s life cycle.

Webinar Agenda

• Understanding inspection readiness from a regulatory agency standpoint for Good Clinical Practice (GCP)
• Knowing how an inspection is conducted including important processes for which to be prepared
• Overcoming challenges in preparing for an inspection with regulatory obligations
• Preparing an effective corrective action and preventative action (CAPA) to solve deficiencies detected during inspections and avoid them in the future