How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach: One and a Half day In-Person Seminar

By: Angela Bazigos, CEO, Touchstone Technologies Silicon Valley Inc.
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Course Description:

The FDA inspection is one of the critical measures of your quality system and your organization as a whole. Since a perfect quality system is usually not implemented, the preparation for and management of an FDA inspection is critically important. A well-established quality system provides a solid foundation for passing FDA inspections; however, if you don’t proactively examine your quality system from the perspective of a FDA inspector, you can still have difficulties. A less than perfect quality system has the potential to attract FDA observations, but if you prepare, proactively identify and mitigate the compliance risks, you can still achieve good inspection results and avoid or minimize negative impact on your business.

Based on extensive experience of both managing inspections from the industry side and conducting inspections from FDA side, this seminar will share insights about FDA inspections and provide a set of comprehensive strategies and instructions on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters.

By attending this seminar on preparing for FDA inspection, participants will learn:

  • Background about FDA inspection program.
  • How to proactively assess quality system readiness for FDA inspection.
  • How to identify compliance risks.
  • How to proactively mitigate before, during and after the inspection.
  • How to respond to 483s and warning letters including templates based on industry best practices.

Additionally attendees will be provided with:

  • Toolkit on how to assess a quality system’s readiness, and identify and mitigate potential compliance risks.
  • A checklist of information that should be prepared prior to inspection.
  • A strategy template on how to manage a FDA inspection (front room, back room, role playing, dos and don’ts, etc.).
  • Toolkit on how to prepare responses to 483 observations and warning letters.

We need the below information to serve you better

If you are looking for the answer to these questions, you will certainly benefit from attending this seminar on preparing for FDA inspections:

  • Do you worry about an upcoming FDA inspection?
  • Do you know how you should behave during the inspection?
  • Do you know what an end to end FDA inspection process looks like?
  • Do you know what an FDA investigator(s) will look for?
  • Do you know how to proactively assess and mitigate FDA compliance risks?
  • Do you know what information you should get ready ahead of an FDA inspection?
  • Does your organization have a game plan for managing an FDA inspection?
  • Does your organization know how to respond to and manage FDA observations (483s), or warning letters?

Course Objectives:

  • To provide an overview of the FDA inspection program and key success factors for a manufacturer.
  • To introduce the best practices on how to manage inspections including a template of game plan.
  • To introduce the industry best practices on what information should be prepared ahead of inspection including a checklist.
  • To introduce the best practices including templates on how to respond to and closeout FDA 483s and warning letters.
  • To introduce the best practices and toolkit on how to assess readiness for a FDA inspection, and how to proactively identify and mitigate compliance risks.

Who will Benefit:

This course will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:

  • Quality Engineers
  • Managers
  • Directors
  • VPs, Regulatory Affairs
  • Auditors
  • Risk Managers
  • Compliance Officers
  • Management Representatives
  • Management with Executive Responsibilities
  • Members of Senior Management Team
  • Validation Managers

Course Outline

Day One (8:30 AM – 5:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Welcome and Introductions (30 Minutes)

  1. FDA Inspection Program Overview (1.5 Hour)
    • Type of FDA Inspections
    • Inspection process
    • Outcome of Inspections
    • Potential business impact – Compliance Risks
  2. Key factors for a successful FDA inspection (0.5 Hour)
    • FDA’s mission
    • FDA investigator’s objectives
    • Organization’s objectives
    • Key factors for a successful FDA inspection
  3. Quality System Readiness (2 Hours)
    • Quality Systems Readiness Assessment
      • Baseline Assessment
      • Additional Assessment
    • Compliance Risk Identification and Mitigation
      • Risk Assessment
      • Plan of Mitigations
      • Story Boards
  4. Information Readiness (1 Hour)
    • Welcome slides
    • Company and Organization information
    • Quality Systems Documents and Records frequently requested
    • Product information
    • Logistic information
  5. Organization Readiness (2 hours)
    • Game Plan: Front Room, Back Room, SMEs, Communications, etc.
    • Facilities
    • Employees
    • Dos and Don’ts
    • Class Exercise: Role Playing
  6. Day one Q&As and Wrap Up (30 minutes)
Day Two (8:30 AM – 01:00 PM)

Welcome (15 Minutes)

  1. Manage FDA inspection Outcomes
    • Study of Examples: (1.5 Hours)
      1. Example of 483
      2. Example of EIR
      3. Example of Warning Letter
    • Response & follow up management (1.5 Hours)
      1. Follow up on EIRs
      2. Manage 483s
      3. Manage Warning Letters
  2. Final Q&As and Wrap Up (30 minutes)

Meet Your Instructor

Angela Bazigos_90x112
Angela Bazigos,
CEO of Touchstone Technologies Silicon Valley Inc.

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

Ms Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry.

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