$994 – $3,195

Preparing for and Managing Successful FDA Inspections (WCS)

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Hilton Garden Inn Boston Logan Airport

100 Boardman Street

Boston, MA 02128

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Description

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



Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(a)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Hilton Garden Inn Boston Logan Airport

100 Boardman Street

Boston, MA 02128

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