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.

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

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Course Outline:

Day One (8:30 AM – 5:30 PM) Day Two (8:30 AM – 1:00 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)

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
CEO of Touchstone Technologies Silicon Valley, Inc.

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

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

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Local Attractions

The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.

Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.

The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.

The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”

An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.

Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.

The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.

One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.

Franklin Square, one of Philadelphia’s five original public squares laid out by William Penn in his original plan for the city, has undergone a dramatic renovation. The park now boasts several family-friendly attractions, including a miniature golf course, classic carousel, burger joint, storytelling bench, picnic area and more.

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