$1,395 – $3,885

2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare...

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Homewood Suites by Hilton San Diego-Del Mar

11025 Vista Sorrento Parkway

San Diego, CA 92130

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2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare

Description

Course “FDA Inspections: What Regulators Expect and How to Prepare “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"

An Interative Workshop Presented BY WCS & David R. Dills

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.

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,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness.

He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company’s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing.

He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals.

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working group

Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sposnsorships

NO REFUNDS ALLOWED ON REGISTRATIONS
Service fees included in this listing.
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Homewood Suites by Hilton San Diego-Del Mar

11025 Vista Sorrento Parkway

San Diego, CA 92130

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