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  FDA Inspection Seminar
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Course Description

Non-compliance is an expense that no healthcare company can afford. Companies must establish proven and sustainable GXP Compliance Strategies and risk mitigation strategies when responding to a crisis so you avoid costly product approval delays, recalls and adverse impacts on shareholder value, including FDA enforcement actions. Companies must adopt a risk-based approach to managing quality and regulatory compliance not only for GCP, GLP and GMP but across the entire platform. Whatever solution you are using it needs to provide a common framework and an integrated approach to meet FDA GxP regulations through effective risk management, document control, compliance training, ongoing auditing, surveillance and monitoring activities and other critical areas that will be addressed during the seminar.

This is a practical, hands-on two-day seminar designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively and successfully. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters.

The course will go through what typically goes on during an FDA Inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will emphasize and focus on the critical and vital elements that you should do or not do during the inspection. Typically, FDA inspections can be highly structured and there are procedures that are to be followed as you prepare for state of readiness. It is important for anyone who might be involved in the inspection to be aware of these procedures, including all employees and personnel to ensure there are no surprises.

The course will also provide information for inspections conducted by international agencies as well as non- FDA agencies, including self-inspections for manufacturing and the famous FDA Mock Inspection or Mock Audit. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection and what follow up to expect after an inspection.

Why Should you Attend?

  • ·      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

Training Agenda

Day 1

  • ·      Introductions and Background
  • ·      FDA’s Inspectional Authority and History
  • ·      FDA Inspection Program Overview
  • ·      Key factors for a successful FDA inspection
  • ·      Quality System Readiness
  • ·      Organization Readiness
  • ·      Manage Inspection Outcomes
  • ·      Information and Documentation
  • ·      How a firm should prepare for an FDA inspection?
  • ·      Ways to train employees in view of the inspection
  • ·      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
  • ·      How to reply to 483's and warning letters
  • ·      Legal implications of non-compliance
  • ·      Why inspections are conducted and by what statutory authority
  • ·      The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
  • ·      What is subject to FDA purview and what's off-limits
  • ·      Understand and apply the do's and don'ts and comprehend that preparation is the key to success
  • ·      What are the prohibited "Acts" and the enforcement categories that you need to deal with?
  • ·      What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key
  • ·      The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
  • ·      How to respond to findings and facilitating the documentation and remediation process...and reaching final closure
  • ·      Define clear responsibilities, roles and goals for personnel involved in FDA inspections and SOP development
  • ·      Exit Interview
  • ·      FDA interviewing employees and personnel

Day 2

  • ·      Maintain, or return to, regulatory compliance and minimize downtime
  • ·      Establish a risk management plan in place to proactively manage compliance, including a crisis-management plan
  • ·      Set post-inspection deadlines and working closely with FDA’s regulatory partners
  • ·      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.
  • ·      Guidance on how to request and conduct PDUFA meetings and expectations for Sponsor-FDA Meetings
  • ·      Guidance outlining clear recommendations for sponsors and for FDA staff and managers as well for Pre-Submission meetings as expected timeframes for scheduling meetings
  • ·      Mechanics of requesting any FDA meeting and what you need to know to be successful with communication style, approach and tactics
  • ·      Prioritize follow-up on warning letters and other enforcement actions
  • ·      Develop and implement a formal warning letter “close-out” process
  • ·      Untitled Letter and the Warning Letters
  • ·      Recent Trends and Enforcement Actions for 2017
  • ·      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 for 2017 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


Who Will Benefit

This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing and FDA inspection and external regulatory inspections and for those companies who 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

Know Your Faculty  

Kelly Thomas, Vice President at America’s Quality Operations, has 20 years of hands-on experience in the industry. She has worked with reputed facilities like FDA, EMEA, IMB, JP, and Health Canada. Her core expertise includes computer system validation, equipment process validation, and facilities validation. In addition, she will guide you on implementing a robust quality system, evaluating the KPIs of the facility, and executing high-quality management. 


RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria