How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection (Arlington, VA, United States - September 26-27, 2018)

  • ID: 4585576
  • Conference
  • Location: Arlington, VA, United States
  • 2 Days
  • NetZealous LLC
  • Conference Dates: September 26-27, 2018
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Course "How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Senior management takes responsibility for Quality and GXP compliance. It is not something delegated to the Quality unit or to the Regulatory Affairs group. Developing and implementing an effective Inspection readiness plan will help ensure better results, as well as a less stressful inspection. Planning strategically ahead will reduce document turn-around time, improve presentation skills from SMEs, and increase inspector confidence in the Quality System. Successfully completing an FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection Management techniques can help mitigate the risk of receiving an observation for compliance gaps. Quality and GXP compliance are an opportunity, not an obligation, and are owned by everyone in the organization. For those interacting with FDA regarding submissions, as an example, every interaction with the FDA is a crucial moment for your development program, and meetings represent a culmination of compiled and scheduled work. Strategies, timelines, costs and complexity are all organized through this interaction - the stakes are high, and the outcomes are extremely important. It all comes down to strategic communication. Every facet of FDA meetings - from the information your company is providing, to scientific research and the tone and articulation of that information - must be conducted flawlessly. For example, for many medical device companies, a meeting with a US Food and Drug Administration (FDA) Advisory Committee is a high-profile, high-stress event. A successful meeting can assure regulators, patients and investors that a product is safe and effective, while an unsuccessful meeting can torpedo a product's chances of a timely approval.

Why you should attend:

This seminar will offer learning on the following:

  • How a firm should prepare for an FDA inspection
  • Ways to train employees in view of the inspection
  • Field Management Directives
  • Sub-Systems for Pharmaceutical and Medical Devices
  • The emphasis on systems-based inspections...and the IOM, QSIT, CPGM and other crucial FDA reference documents
  • How to ensure that required documentation is in place
  • How to interact with the investigator-DO's and DON'T's
  • What companies should do when the inspection ends
  • Post inspection actions
  • Why inspections are conducted and by what statutory authority
  • The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
  • Define and execute proven GxP Compliance Strategies
  • Proven Operational Readiness and State of Readiness tactics
  • Determine optimal pathway during inspections and post-inspection correspondence and meetings
  • Identify the visible signs of GXP compliance that are present as a daily reminder of the importance of GXP compliance with "risk-based" awareness demonstrated by companies
  • Improve credibility and trust with FDA and other regulators
  • Important training areas in GxP compliance and topical issues
  • Gain a better understanding of how to interact and communicate effectively with FDA
  • Identify the ground rules and do's and don'ts with FDA inspections
  • Learn what FDA can request and not request during an inspection
  • Understanding the interview process and why pre-inspection planning is critical for your company
  • Navigate the inspection process from preparation, execution to close-out and debrief/exist interview
  • FDA authority and process including 483s, Warning Letters, recalls, and other potential actions
  • The FDA inspection process and approach
  • The use of a mock audit and outside certifying audit
  • Required documentation, format, and archive
  • How to respond to inspection and audit results
  • In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions for any FDA inspection
  • Prepare for lively discussions and a mock inspection as part of a classroom exercise
  • Communicate effectively with FDA and reference FDA guidance and other critical resources.
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Day 1 Schedule
Lecture 1: Introductions and Background
Lecture 2: FDA's Inspectional Authority and History
Lecture 3: FDA Inspection Program Overview
Lecture 4: Key factors for a successful FDA inspection
Lecture 5: Quality System Readiness
Lecture 6: Organization Readiness
Lecture 7: Manage Inspection Outcomes
Lecture 8: Information and Documentation
Lecture 9: How should a firm prepare for an FDA inspection?
Lecture 10: Ways to train employees in view of the inspection
Lecture 11: How to ensure that required documentation is in place
Lecture 12: How to interact with the investigator-DO's and DON'T's
Lecture 13: What companies should do when the inspection ends
Lecture 14: How to reply to 483's and Warning Letters
Lecture 15: Legal implications of non-compliance
Lecture 16: Why inspections are conducted and by what statutory authority
Lecture 17: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents such as QSIT
Lecture 18: What is subject to FDA purview and what's off-limits
Lecture 19: Understand and apply the do's and don'ts and comprehend that preparation is the key to success
Lecture 20: What are the prohibited "Acts" and the enforcement categories that you need to deal with?
Lecture 21: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key
Lecture 22: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
Lecture 23: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure
Lecture 24: Define clear responsibilities, roles and goals for personnel involved in FDA inspections and SOP development
Lecture 25: Exit Interview
Lecture 26: FDA interviewing employees and personnel
Lecture 27: Management Controls, Production and Process Controls, Design Controls, CAPA, and sub-systems

Day 2 Schedule
Lecture 1: Quality System, Facilities and Equipment System, Materials System, Production System, Laboratory Controls and Operations, Packaging and Labeling System
Lecture 2: Maintain, or return to, regulatory compliance and minimize downtime
Lecture 3: Establish a risk management plan in place to proactively manage compliance, including a crisis-management plan
Lecture 4: Set post-inspection deadlines and working closely with FDA's regulatory partners
Lecture 5: Compliance remediation is the process of recognizing problems, creating a plan to correct and prevent them from occurring in the future, and executing to that plan to helps with your GxP Compliance Strategy.
Lecture 6: Guidance outlining clear recommendations for sponsors and for FDA staff and managers as well for Pre-Submission meetings as expected timeframes for scheduling meetings
Lecture 7: Mechanics of requesting any FDA meeting and what you need to know to be successful with communication style, approach and tactics
Lecture 8: Prioritize follow-up on warning letters and other enforcement actions
Lecture 9: Develop and implement a formal warning letter "close-out" process
Lecture 10: Untitled Letter and the Warning Letters
Lecture 11: Recent Trends and Enforcement Actions
Lecture 12: Mock Inspections and Mock Audits and why role playing is important
Recap of Day 1 and Day 2

Exercise on Day 2

  • Interactive Discussions
  • Review Regulatory and Compliance Documentation
  • Recent Enforcement Actions and Emerging FDA Trends
  • Classroom Project: Prepare for and Host an FDA Mock Inspection and Prepare Effective Company Response to FDA 483 and/or Warning Letter
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  • David R. Dills David R. Dills,
    Regulatory Affairs & Compliance Consultant ,
    David R. Dills

    David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space.

    He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

    Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems.

    This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus.

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Who will benefit:
This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing an FDA inspection and external regulatory inspections and for those companies which must establish proven and sustainable GXP compliance strategies and risk mitigation strategies when responding to a crisis. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the FDA inspection process from preparing for the inspections, during the inspections and post-inspection responsibilities and follow up activities with FDA, including:

  • Executive Management
  • Regulatory Affairs Management
  • Regulatory Affairs Specialist
  • Auditors
  • QC/QC Management
  • Compliance Officer
  • Compliance Specialist
  • Clinical Affairs
  • Quality Assurance Management
  • Marketing & Sales
  • Laboratory Operations
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Engineering/Technical Services
  • Operations/Manufacturing
  • Consultants
  • Individuals who come in contact with regulatory inspectors
  • Auditors
  • Compliance/Regulatory affairs professionals
  • QA/QC professionals
  • Manufacturing managers, supervisors & personnel
  • Project Managers
  • Regulatory Affairs Management
  • Regulatory Affairs Specialist
  • Compliance Officer
  • Compliance Specialist
  • Clinical Affairs
  • Distributors
  • Legal Counsel
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Courtyard Arlington Crystal City/Reagan National Airport
2899 Jefferson Davis Highway
Arlington, VA
United States

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