Industries: Pharma / BiotechMedical Device

FDA Inspections - What Regulators Expect and How to Prepare

Course Director: Kerry Potter

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

 

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

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, biologics, and device facilities.

Additional benefits of this class include discussion of:

  • FDA authority and process including 483s, Warning Letters, recalls, and other potential actions
  • The FDA inspection process and approach
  • Device Master Records requirements
  • The use of a mock audit and outside certifying audit
  • Required documentation, format, and archive
  • How to respond to inspection and audit results
  • Parallel process from the EMEA, TGA, PMDA, and other international regulatory agencies
  • A chance to actively learn form fellow participants and well as from an instructor who brings 30 years of practical regulatory experience to a lively combination of lecture, discussion, and exercises

Who Should Attend

This is a practical, hands-on course 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. Our FDA inspection preparation course is ideal for Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.

Course Agenda

First Day

Introduction

  • Participant goals, issues and questions: a flexible framework to assure that everyone leaves with the information they need
  • FDA Inspections: authority, guidelines, internal agency controls
  • Strategies for copies with FDA inspections

The Inspection Process

  • Systems and traditional inspection approaches
  • Establishing clear SOPs and policies
  • Managing the process
  • Device issues: engineering, quality control, and the Device Master Record (DMR)
  • Common 483s and warnings

MOCK AUDIT (workshop): Case Study of a Manufacturing Facility Inspection: Systems Inspection

  • FDA inspection questions
  • Documentation
  • CAPA: corrective and preventive actions
  • OOS: "Out of Specification" prevention and response

Legal Issues

  • Executive responsibility and vulnerability
  • Management review
  • Staff training
  • FDA authority and powers

Second Day

FDA Inspection Checklist: Do's and Don'ts

  • Documentation preparations
  • Hosting investigators
  • What not to say
  • Key roles and players
  • Responses to the inspections
    • Initial response
    • Challenge
    • Dispute

Emerging Issues

  • Part 11 Signatures and records: latest interpretation, 483s
    • Signature authentication
    • Archiving
    • Audit trails
  • QbD product development and design: latest interpretation, 483s
    • Process Analytical Technology (PAT)
    • Design space
    • Risk analysis
  • Special device issues
    • Engineering
    • DMR
    • Testing
  • Other emerging 483 issues

MOCK AUDIT (workshop): Case Study-GMP Audit Medical Device

  • FDA inspection questions
  • Documentation
  • CAPA: corrective and preventive actions
  • OOS: Out of specification: prevention and response
  • The DMR

Uses and Limits of Internal Audits

  • Fear factor
  • Inside versus outside
  • Checklist
  • A model of successful audits
  • A model for FDA inspections

Learning Objectives

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

  • Understand the guidelines, philosophy and practical approach of the FDA to inspections and visits
  • Understand the new FDA "systems approach" to inspections (QSIT), and the differences from the traditional "issues" approach
  • Develop strategies for preparing for and coping with FDA inspections
  • Plan for a self-audit in anticipation of FDA inspections
  • Have resources for reference and update

Testimonials

"We only take courses with CfPIE and both I've attended have been very good." David C., QC Pharmacist, Kaiser Permanente
"This course was more specific and in-depth than courses I’ve taken with other training providers. I wish you offered courses in Dubai or Abu Dhabi" 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. I enjoyed the interaction Kerry had with us and liked very much that he included us in the training process." 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.
"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
"Instructor had a great demeanor and good presentation skills. He was very easy to listen to and made his points well and clearly. 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.,
"A true asset to your company. He sets the mark high. Pay him more! Information was great and interactive. Pay him more!" Mitchell H., Quality Manager, Pfizer
"One of the all-time best instructors I have encountered in my career. Kerry knows his subject matter and was able to truly present it in an engaging fashion. Well done! Frank, Director, IT Audits, Pfizer
"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 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
"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

Frequently Asked Questions

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.

RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.