America's Top Tradeshow Directory | Events In America
Facebook Linked In Twitter Videos

Paid membership required to see this information

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. We provide tips for Executive Management/CEO’s, Production area staff, Reception Area staff and what each group needs to know during an inspection. The session includes real life inspection scenarios/case studies. Participants are given real life FDA inspection scenarios and are asked to discuss how they would handle each situation. Feedback is given on how to best handle each situation and scenario. This is one of our most popular training sessions!

Learning Objectives:

If you are looking for answer of these questions, you would certainly benefit by attending this seminar:

  • Which FDA sanctions apply to you, and how to operate in compliance with FDA requirements.
  • What to do when FDA knocks – step by step instructions to handle inspections.
  • How to handle day by day inspection scenarios?
  • What is a front room and back room? Do you need one?
  • Runners and Scribes? What do they do?
  • Are your SME’s the right people, and are they ready/right for the job?
  • Why responses to 483’s and Warning Letters are critical?
  • Steps for responding to 483’s and Warning Letters.

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

If the Why is FDA at my facility, and what do I do during an inspection?: 2-day In-person Seminar is important to your business, act now and make the appropriate connections. See the contact information below.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Conference/Event Dates: 10/20/2016 - 10/21/2016
Conference/Event Hours: 8:30 AM to 4:30 PM
Classification: B2B
Primary Industry: Sciences
Other Industries: Business, Sciences
Estimated Attendance: 30
Cost to Attend: One Registration: $1499
Audience: Manufacturing facilities
Private label and contract manufacturing facilities
Distributors, warehouses
Own label distributors, private label distributors
Packers, Labelers
Ingredient suppliers
Venue: Venue TBD
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
Call for information.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

Advance Networking

How do I show up here?

Personal Notes

Add a note here, it is only visible by you.

New Search Contact This Event