Preparing for and Managing Successful FDA Inspections

By: David R. Dills, Director of Regulatory Services at CROMSOURCE.
Product code: SEM65
Location 1: Chicago Sep 09 - 10

Description

Course “2 Days Workshop Preparing for and Managing Successful FDA Inspections " has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop Tuition per attendee includes the two-day workshop, all workshop materials, Complimentary breakfast and lunch both days provided by WCS"

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 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

  • Identify the ground rules and do’s and dont’s 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
  • Parallel process from the EMEA, TGA, PMDA, and other international regulatory agencies
  • 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

Areas Covered

  • 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
  • Class I: Low Risk (similar to Class 1 of the EU System)
  • Class II: Medium Risk (similar to Class 2a of the EU System)
  • Class III: Medium High Risk (similar to Class 2b of the EU System)
  • Class IV: High Risk (similar to Class 3 of the EU System)
  • 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
  • Mock Inspections and Mock Audits and why role playing is important

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. 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
  • Compliance Officer
  • Compliance Specialist
  • Clinical Affairs
  • Quality Assurance Management
  • Marketing & Sales
  • Laboratory
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Engineering/Technical Services
  • Operations/Manufacturing
  • Consultants

Learning Objectives

Course Outline:

  • 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
  • Class I: Low Risk (similar to Class 1 of the EU System)
  • Class II: Medium Risk (similar to Class 2a of the EU System)
  • Class III: Medium High Risk (similar to Class 2b of the EU System)
  • Class IV: High Risk (similar to Class 3 of the EU System)
  • 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
  • Mock Inspections and Mock Audits and why role playing is important

 

 

speaker

David R. DillsDirector of Regulatory Services at CROMSOURCE

David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific. He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, among other regulatory and compliance responsibilities. 

09-September-2020 To 10-September-2020 Chicago
Seminar One Registration
$ 1497 (Early Bird)



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How to Reach

Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

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Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou. 


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15-20 minutes product demo during the live session

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