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

Learning Objectives:

This course has been planned to:

• Provide the essential skills and tools to prepare for, host and react to a GCP regulatory inspection
• Identify key stakeholders in the inspection process
• Enable recognition and prioritization methodologies to prepare for an inspection
• Plan and prepare efficiently for an inspection
• Establish what will be inspected.
• QA, checking, QC and monitoring before, during and after an inspection
• Prepare your site/company/organization to be “inspection ready”
• Dos and Don’ts when preparing the TMF for inspection.
• Facilitate the response and follow-up to the inspection outcome, findings (483s)
• Provide guidance on best practices to conduct the necessary Corrective Actions and Preventive Actions (CAPA) processes.
• Provide an understanding of the differences between GCP inspections at Sponsor and Contract Research Organization (CROs) and inspections conducted at clinical investigator sites.
• Provide real past examples common inspectional findings as well as current GCP inspection finding trends.
• Outline regulatory inspections’ current critical topics/focus trends.
• Provide a comparative review of the differences between methodologies and practices used by FDA investigator (inspectors) and inspectors coordinated by the European Medicines Agency (EMA).

Areas Covered:

• Inspection Rationale and Process
• Essential relevant definitions
• Reasons for inspections
• FDA Legal Framework for conducting regulatory inspections
• Types of inspections conducted by the FDA
• What are the typical background and experiences of FDA Investigators (inspectors)?
• How do the FDA investigators (inspectors) prepare for the inspection?
• The objectives and goals of the inspector
• Inspection Readiness
• The Three Stages of Inspection Management
• Stake Holders during an FDA Inspection at Clinical Sites
• Stake Holders during an FDA Inspection at Sponsor/Clinical Research Organization (CRO)?
• Before the inspection: Preparing the organization for an Inspection:
• The essential skill sets, and tools needed to prepare and host a regulatory inspection
• Conducting Mock Inspections
• Simulating Investigator (inspectors) Interviews
• Selecting and Training Subject Matter Expert (SMEs)
• Logistical preparation for the Inspection
• Preparing the TMF for inspection
• Some Common Pitfalls
• Training Subject Matter Experts
• During the inspection: Conduct during an Inspection:
• How to prepare for the Inspection Opening Meeting
• Scope (areas likely to be inspected)
• At a clinical investigational site
• At the trial sponsor/CRO
• At a clinical central laboratory
• Best practices when interviewed by inspectors:
• Interview Dos and Don’ts
• Dealing with difficult questions
• Closing Meeting of the inspection:
• How to prepare for closure of the inspection?
• How to respond to Major and Critical observations during the Closing Meeting?
• After the inspection:
• What needs to be done when receiving a finding?
• Criticality/Ratings of Observations: what does each rating mean? What needs to be done in response to each finding?
• Regulatory inspections’ current critical topics/focus trends
• How to respond to Form 483 and follow-up to the inspection outcome?
• How to deal with a “Critical” observation?
• Corrective Actions and Preventive Actions (CAPA): How to develop a plan of action to Analyse, Respond & Remedy any deficiencies?
• Analysis & investigation;
• Establish Remedial & Preventative Plans;
• Respond to the inspecting agency on CA already done and rest of the plan;
• Continually review CAPA progress
• Some real past examples common inspectional findings as well as current regulatory GCP inspection finding trends
• What are your biggest concerns about an FDA Inspection?
• Lessons Learned

Who will Benefit:

Clinical Research/Trials’ Leaders, Data Managers, Clinical Trials Physicians, Clinical Research Coordinators, Clinical Investigators, Study Nurses, Clinical Research Associates, Pharmacovigilance/Drug safety Professionals, QA GCP Auditors, Drug-, Biological- and Medical Device-makers, Executive suite, Regulatory affairs, QA GVP Auditors, Strategic planners, Legal Counsel, Clinical Trials Managers, TMF Managers, Consultants.