Managing Regulatory Inspections Training – The Dos and Don’ts Before, During And After an FDA GCP Inspection: 2-Day In-Person Seminar

By: Amer Alghabban, Managing Director, GxP Compliance and Training Partners (GCTP)
Location :- Zurich, Switzerland | Monday, December 2, 2019 | Tuesday, December 3, 2019

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Course Description:

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).

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.

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.30 AM - 09.00 AM - Registration
  • 09.00 AM - Session Start Time
  • 9:00 AM - 10:00 AM
    • Seminar objectives review, expectations and scope
    • Inspection Rationale and Process
    • Definitions
  • 10:00 AM - 11:00 AM
    • FDA Legal Framework for conducting regulatory inspections
    • Why do they inspect?
    • Types of inspections
    • Who are the FDA Investigators?
    • How do the FDA investigators (inspectors) prepare for the inspection?
  • 11:00 AM - 12:00 PM
    • What is the Inspector looking for?
    • What is Inspection Readiness?
    • Who Are the Stake Holders during an FDA Inspection at Clinical Sites?
    • The Three Stages of Inspection Management
    • Who Are the Stake Holders during an FDA Inspection at Sponsor/Clinical Research Organization (CRO)?
  • 12:00-1:00 PM Lunch
  • 1:00 PM - 2:00 PM

    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
  • 2:00 PM - 3:00 PM

    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
  • 3:00 PM - 4:00 PM

    Best practices when interviewed by inspectors:

    • Interview Dos and Don’ts
    • Dealing with difficult questions
  • 4:00 PM - 4:15 PM
    • Closing Meeting of the inspection
    • How to prepare for closure of the inspection?
  • 4:15 PM - 4:30 PM
    • How to respond to Major and Critical observations during the Closing Meeting?
  • Day Two (8:30 AM – 4:30 PM)
  • 08.30 AM - 09.00 AM – Registration
  • 09.00 AM - Session Start Time
  • 9:00 AM - 10:00 AM

    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?
  • 10:00 AM - 11:00 AM
    • 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?
  • 11:00 AM - 12:00 PM

    Corrective Actions and Preventive Actions (CAPA): How to develop a plan of action to Analyse, Respond & Remedy any deficiencies?

    • Analysis & investigation
    • Establishing Remedial & Preventative Actions (CAPA) Plans
    • Communicating with the inspecting agency on progress of the CAPA; Corrective actions already done and rest of the plan
    • Continually review CAPA progress
  • 12:00 - 1:00 PM Lunch
  • 1:00 PM - 2:00 PM
    • Some real past examples common inspectional findings as well as current regulatory GCP inspection finding trends
  • 2:000 PM - 3:00 PM
    • Examples of proposed CAPAs: the good, the bad and the ugly
  • 3:00 PM - 4:00 PM
    • What are your biggest concerns about an FDA Inspection?
  • 4:00 PM - 4:30 PM
    • Preparing, Hosting, Managing FDA regulatory inspections: Lessons learnt
  • Meet Your Instructor

    Amer Alghabban
    Amer Alghabban
    Managing Director, GxP Compliance and Training Partners (GCTP)

    Amer Alghabban, M.Sc. (Clin. Pharmacology), Post-Grad. Cert. Clinical Research, Dipl. Bio. Sci., B.Sc., Cert. Teacher Education, M Soc. Pharm. Med., MRQA, MIQA, MDIA, ISO 9001:2015 QMS Certified Lead Auditor, IRCA Certified Lead Auditor.

    Amer is currently the Managing Director of GxP Compliance and Training Partners (GCTP), which he founded, helping pharmaceutical companies & academic institutions worldwide to achieve compliance with GCP, GVP, GCLP, GDP and GLP.

    Amer, a Clinical pharmacologist by education, has over 28 years’ experience in the pharmaceutical industry. He enjoys imparting his experiences, as an invited speaker at over 125 international congresses and as writer; he published 2 reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. Amer has experience of working at the MHRA where he participated in the conduct of the very first Regulatory Authority pharmacovigilance-GCP inspection in the EU and wrote the 1st EU regulatory authority SOPs on conducting GVP inspections. He has over 21 years’ experience of directing Inspection Readiness Programs (Mock Inspections & Pre- & Post-Mock Inspection-Training) and hosting regulatory authorities’ & notified bodies’ inspections. To date, he has prepared, trained, hosted & managed over 67 Regulatory Authorities’ inspections by all major regulatory authorities (FDA, EMA, EU Authorities (CAs), Japanese PMDA, Brazilian, Chinese SFDA & Middle Eastern authorities etc.) Earlier in his career, he was Assistant Editor for 11 medical journals and was the 1st invited Course Director for The Pharmacovigilance Auditing Course at the RQA.

    Amer’s other previous positions included: Vice President GxP Quality Assurance, Compliance & Training at Karyopharm Therapeutics Inc. Boston, USA, Global Director, Head of Quality Assurance at Merck Serono, Geneva, Switzerland, Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.

    Venue

    Location:
    Zurich, Switzerland (Venue to be announced shortly)

    December 2-3, 2019
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