Preparing for and Managing Successful FDA Inspections -2-day In-person Seminar

By: David R Dills, Regulatory Affairs & Compliance Consultant.
Product code: SEM19
Location 1: Boston Jul 13 - 14

Description

An Interative Workshop Presented BY WCS & David R. Dills

Course “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 materials by the speaker. Seminar Also Includes Certificate, 

Complimentary Breakfast, Lunch & High Tea/Coffee 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.

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

- 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

 

Who will Benefit

- 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

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 f

Course Outline:

Day 1 09:00 AM - 05:00 PM

  • 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
  • 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 

 

Day 2 09:00 AM - 05:00 PM

  • 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 DillsRegulatory Affairs & Compliance Consultant

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provid

Seminar One Registration
$ 1096
13-Jul,2017 Boston


Special Group Discount Register for Four attendees
$ 3999

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 2% off

3 to 6 Attendees - 5% off

7 to 10 Attendees - 7% off

10+ Attendees - 15% 0ff

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Hilton Garden Inn Boston Logan Airport $169 / Night

Address: 100 Boardman St, Boston, MA 02128, USA

Phone: +1 617-567-6789

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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.

 

Media Partners

Top Media Partners and Sponsors World Compliance Seminars WCS


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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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$2,000 - Silver Sponsor Package Includes

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Sponsors materials will be distributed onsite to all the attendees

15-20 minutes product demo during the live session

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