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Managing Regulatory Inspections Training - The Dos and Don'ts Before, During And After an FDA GCP Inspection


"Reasons for inspections"
Good Clinical Practice (GCP) inspection by the US Food and Drug Administration (FDA) can lead to the detection of problems with the conduct of your clinical trials. FDA requirements regarding GCP and related inspections have been around for decades. Despite this, GCP noncompliance is still a major reason for FDA rejection of clinical study data or other regulatory action. Often, simple proactive steps can be taken to strengthen your GCP program and help you survive these inspections. This .. continue reading interactive, 180-minute online course will provide you with the tools to safeguard against inspection deficiencies and satisfy regulatory agencies that your efforts are compliant. These steps need to be taken before, during, and after an FDA GCP Inspection. Undertesting the legal frameworks and reading between the lines are paramount to enable better understanding and consequently better inspection readiness, performance during these inspections and optimal handling of inspection outcome.

Highlights

  • Provide the essential skills and tools to prepare for, host and react to a GCP regulatory inspection
  • Enable recognition and prioritization methodologies to prepare for an inspection
  • Facilitate the response and follow-up to the inspection outcome, findings (483s)
  • Provide real past examples common inspectional findings as well as current inspection finding trends
  • QA, checking, QC and monitoring before, during and after an inspection

Timings

8:30 AM - 4:30 PM (Dec 02) (General)
8:30 AM - 4:30 PM (Dec 03) (General)

Entry Fees

Paid Ticket Starts from 1899 USD View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma

Editions

02 - 03 Dec 2019 Interested


Frequency Bi-annual

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ComplianceOnline USA

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User Community [ Users who have shown interest for this Event ]

Jonathan

Jonathan

Accra, Ghana
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Visitor Ticket Price Buy Now

1899 USDAttendee Seminar One Registration (USD)
47.377000 8.542000

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Zürich, Switzerland

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