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