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3rd Edition Conference

Why is FDA at my facility, and what do I do during an inspection

06 - 07 Feb 2020  New Date Reminder
University Club Atop Symphony Towers, San Diego, USA

About Users 4 Reviews Exhibitors Photos 4 Speakers 2 Travel Deals

"Quality Assurance management"
This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included.This course begins with a high level discussion about why FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. Next, we cover what to expect during the inspection, including how to communicate with the investigators, run your front and back rooms, and present documents and records. We cover do’s and don’ts, choosing your core inspection team, facilitators, Subject Matter Experts (SME’s), runners and scribes.

Highlights

  • Legal Obligations, FD&C Act and 704(a)(1), Right to Inspect, Case Law - Real Life Examples
  • FDA Enforcement, Management Responsibility from FDA’s View, FDA Inspection
  • SME Training and FDA-483’s / Warning Letter Responses, FDA Interviews
  • How To Get The Best Out of The Inspection, Replying to FDA-483’s and Warning Letters
  • Which FDA sanctions apply to you, and how to operate in compliance with FDA requirements.

Timings

8:30 AM - 4:30 PM (Feb 06) (General)
8:30 AM - 4:30 PM (Feb 07) (General)

Entry Fees

Paid Ticket Starts from 1499 USD View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Food & Beverages

Editions

06 - 07 Feb 2020 3rd Edition
23 - 24 Feb 2017 2nd Edition
05 - 06 Feb 2015 1st Edition
View More

Frequency Bi-annual
Next edition likely in Aug 2020

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ComplianceOnline USA

Top Rated 375 Total Events / 23 Upcoming Events

User Community [ Users who have shown interest for this Event ]

Dr Farwa

Dr Farwa

Physician at Any

Sialkot, Pakistan
Tim Dowe

Tim Dowe

Holistic/ Natural Food, ingredient Importer at 25 Degrees Co.

Irvine, United States
Globalcompliance Panel

Globalcompliance Panel

Fremont, United States
Michelle Negrete

Michelle Negrete

La Mesa, United States

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Speakers (past edition)

Speaker
Martina LaGrange

Martina LaGrange

Principal at FDA Compliance Group LLC United States
Speaker
Shelly Maifarth, RAC

Shelly Maifarth, RAC

Principal at FDA Compliance Group LLC United States

Visitor Ticket Price

1499 USDAttendee Seminar One Registration
32.718334 -117.157870

Venue Map & Directions

map of University Club Atop Symphony Towers

University Club Atop Symphony Towers

750 B St #3400 San Diego CA 92101
USA

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