FDA Inspections - What Regulators Expect and How to Prepare

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    "We only take courses with CfPIE and both I've attended have been very good."


    David C., QC Pharmacist, Kaiser Permanente

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    "This course was much better than others I’ve taken with different training providers. The course provided specific, real world examples."


    Ranyelle R., Field Application Scientist, Molecular Devices

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    "The Course Director displays and conveys knowledge and experience about the topic. He is an excellent facilitator and instructor. He is very adept at active listening. He has a strong sense of purpose in the course material and in his need for quality in his delivery. He knows the material. He is passionate about informing the class members."


    Paul A., Principal Scientist, RJR

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    "The Course Director's presentation was absolutely fabulous. Although I come from the GCP world, specific modules of her course were very helpful to my current needs. The instructor's VAST knowledge and ability to deliver it. Most importantly, the instructor's delightful personality made our two day course very worthwhile and enjoyable."


    Billie G., CQM Advisor (Auditor), AstraZeneca

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Course Director

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Course Fee

$1650.00 Regular Registration

$1450.00 Early Bird Pricing (Register 30 Days in Advance)

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Course Brochure

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Course Description

This FDA inspection preparation course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical facilities.


Additional benefits of this class include discussion of:


  • FDA mission, expectations and inspection authority
  • GMP Overview
  • Expectations of regulatory inspections
  • 483s, Warning Letters, recalls, and other potential actions
  • Details of the FDA inspection process and approach by inspectors/investigators
  • 21 CFR regulations and Guidance Documents as they apply to FDA inspections
  • Types of inspections
  • Roles and responsibilities and planning of inspection readiness
  • How to manage an FDA inspection
  • Do's and Don'ts of interviews and the inspection process
  • Mutual Recognition Agreement and parallel process with other international regulatory agencies
  • How to respond to FDA inspection findings and start to generate and execute a detailed remediation plan
  • Actively learn from fellow participants and well as from an instructor who brings over 20 years of practical compliance and regulatory experience to a combination of presentation, discussion, and activities related to FDA inspections

Who Should Attend

This 10-hour course is a practical, hands-on course designed to provide all FDA-regulated industry professionals with the information and tools they require to prepare for and manage an FDA inspection.


The course is ideal for the following disciplines:


  • Managers/Directors of Regulatory Affairs and Quality Assurance
  • Auditors
  • Consultants or contractors hired to help firms prepare for inspections
  • Documentation Management
  • Plant and Executive Management
  • Any associates who may interact with FDA inspectors/participate in an inspection
  • Anyone who is looking to learn more about FDA inspections
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  • Learning Objectives

    The course is designed to meet the objectives of preparing for – and surviving – a successful FDA inspection.  Upon completion of the course you will:

    • Recognize the guidelines, philosophy and regulatory expectations of the FDA to inspections and visits
    • Comprehend the FDA "systems approach" to inspections, and the differences from the traditional "issues" approach
    • Develop strategies to prepare for and manage FDA inspections
    • Observe how to conduct a self-inspection in anticipation of FDA inspections
    • Have resources for reference and update
    • Fully understand the “do’s” and “don’ts” during an inspection
    • Fully understand how best to respond to FDA inspection observations

  • Agenda


    Introduction

    • Participant goals, issues and questions: a flexible framework to assure that everyone leaves with the information they need

    The FDA

    • The FDA’s mission, philosophy and expectations to inspections
    • FDA’s 21st century initiative
    • FDA’s responsibilities
    • GMP Overview

    Inspection Readiness

    • Roles and responsibilities of site leadership and Quality
    • The Inspection team and training roll-out
    • Infrastructure preparedness
    • The Inspection Readiness Kit
    • Mock inspection

    Inspection Management

    • Steps to managing the inspection
    • FDA arrival
    • Daily and closing meetings (internal and with the FDA)
    • Tours and interviews
    • Documenting the inspection

    SIMULATED INSPECTION (workshop setting): Case Study of a Regulatory Inspection

    •  Inspection activities
    • Observations
    • Inspection readiness

    Inspection Training

    • Participant responsibility and vulnerability
    • Do’s and Don’ts

    FDA Regulations and Inspections

    • 21 CFR requirements
    • FDA inspector’s guidance and expectations
    • FDA Forms 482, 483, 484
    • Investigations Operational Manual
    • Six system approach vs. traditional approach
    • QSIT

    Challenges

    • Global regulatory agencies
    • Internal audits (self-inspections)

    Responding to FDA Inspection Findings

    • How and when to respond to the findings
    • Remediation planning and execution
    • Follow-up activities

    Communication Management

    • Communication with the inspector
    • Communication with the company and employees

    INSPECTION VIGILANCE (workshop setting): GMP Inspection of a Pharmaceutical Company

    • Description of setting/inspection
    • Review and discuss the case details 
    • Review and determine how the inspection would proceed
    • Describe inspection readiness kit 
    • Determine actions to manage the FDA inspection and follow-up
    • Documentation

    Lessons Learned

    • Additional internal challenges
    • Maintaining an inspection preparedness posture at all time

  • Testimonials

    "This course exceeded all expectations, and I enjoyed how well the instructor lead the course."

    Tristan A., VP of Quality, Willow Birch Pharma


    "We only take courses with CfPIE and both I've attended have been very good."

    David C., QC Pharmacist, Kaiser Permanente


    "In comparison to other training companies, I have never taken a course like this, but I have taken some ISO courses. I liked this one better since the handouts and work was provided and on hand.  I enjoyed how interactive and personal the instructor was. If the instructor is not good, the class can fail, so glad she was great.”

    Daniel D., Chemist, Calumet Penreco


    "This course was much better than others I’ve taken with different training providers. The course provided specific, real world examples."

    Ranyelle R., Field Application Scientist, Molecular Devices


    "Excellent! Better than other training providers. I enjoyed the engagement in role playing and group activities."

    Johnny S., Validation Engineer, CAI


    "This course was more specific and in-depth than courses I’ve taken with other training providers."

    Kamran A., Corp Quality & Regulatory Director, ADCAN Pharma


    "This course was both dynamic and interactive. The class size was great."

    Joseph T., Validation Specialist, Commissioning Agents (CAI)


    "This course was very informative. I was very impressed with the instructor's knowledge."

    Susan S., Director of Operations/Quality Assurance, Remedy Repack


    ""Well done! As a newcomer, the information provided was informative and presented in a way that was easily understood."

    Martin T., Manager Product Safety and Regulatory Affairs, Arkema Inc.


    "Exercises were relevant and made points clearer and relative. Information was current and related directly to regulations and will help significantly to improve our audit readiness."

    William K., Director of Quality Assurance and Regulatory Compliance, Almac Clinical Technologies


    "The course was very informative and valuable for me. The instructor was very engaging and knowledgeable on the subject. This was one of the best training courses I have taken!"

    Linda Babbitt, Quality Systems Manager, Comar, Inc.,


    "I am planning to go back and tell my management that this course should be required for all Quality Auditors, as well as, people who create/write procedures. This is the most useful course I've ever taken!"

    Jen M., Systems Manager, Schering Plough


    "In the relatively short timeframe available, and given the subject matter covered, this course was an excellent overview. Hosted by a fantastic instructor in a nice setting too!"

    Hillsley G., Regulatory Affairs Mgr., Micro Medical Ltd.


    "Information is extremely useable in EU. Information not only related to US situations."

    Jan-Willem A., Quality Manager, Sanquin D&R


    "The Course Director was very knowledgeable and approachable. I would definitely take another class from CfPIE and recommend this course to others."

    Robbin M., QC Manager, Novo Nordisk


    "This course was very beneficial. Very nice atmosphere and very knowledgeable and approachable presenter. This course is a must when preparing for an FDA inspection."

    Michelle R., Quality Systems Supervisor, Cook Medical


    "This course was very exciting and I learned tons of new information that will be immediately useful in my daily activities."

    Bertram B., Quality Engineer, Porey Technologies


    "The instructor was very knowledgeable in the course topic and did a great job thoroughly presenting the very useful and applicable material! Well done!!"

    Jennifer D., Sales and Marketing Manager, Vitaflo USA


    "This course was just the right pace, containing the right amount of examples, and information. It was a great learning experience! Just the right combination of verifying what I already knew mixed with learning some new concepts. The Course Director is simply the best!"

    Henry G., QA Specialist II


    "The Course Director was very knowledgeable. The course is a must for any person in charge of handling an FDA inspection."

    Mario M., Regulatory Compliance Manager, Hospira Costa Rica


    "The Course Director's presentation was absolutely fabulous. Although I come from the GCP world, specific modules of the course were very helpful to my current needs. The instructor's VAST knowledge and ability to deliver it. Most importantly, the instructor's delightful personality made our two day course very worthwhile and enjoyable."

    Billie G., CQM Advisor (Auditor), AstraZeneca


    "This was an excellent course with an excellent Course Director. Very personable and knowledgeable instructor. I look forward to seeing the coming course lists and possibly attending future courses."

    Michelle L., Assistant Director, Drug Safety/Medical Affairs, ICON Clinical Research

FAQs

  • Is the class specific to pharmaceutical inspections?

    Generally, the material is targeted to the pharmaceutical industry. However, the expectations for all FDA regulated industries (e.g. clinical, medical device) are covered.

  • Does the course include inspection of tobacco manufactures?

    In that inspection regulations have not been adopted by the FDA, the instructor makes analogies to the tobacco industry throughout the course to assist such firms with inspection expectations.

  • I've attended other course on FDA inspections - telling me what my company needs to do. How is this course any different?

    The instructor not only covers how companies need to prepare for an inspection, but also reviews (and reveals) how FDA inspectors prepare themselves to conduct an inspection.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.