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

ComplianceOnline

Thursday, October 20, 2016 at 8:30 AM - Friday, October 21, 2016 at 4:30 PM (PDT)

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

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (Early Bird Price)
Registrations after October 5, 2016 - $1699
Oct 20, 2016 $1,499.00 $0.00
Seminar One Registration Oct 20, 2016 $1,699.00 $0.00
Seminar One Registration (With 2 Nights Stay) Oct 20, 2016 $2,199.00 $0.00

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Event Details

Course Description:

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.

Who will Benefit:

Industries Positions/Titles Types of facilities:
  • FDA regulated Industries
    • Medical Device
    • Pharmaceuticals
  • Dietary Supplements
    • Food
    • Med Tech
  • Top and Middle Management
  • Subject Matter Experts (SME)
  • Quality Assurance/management
  • Compliance Management
  • Manufacturing
  • Laboratory
  • Regulatory Personnel
  • Manufacturing facilities
  • Private label and contract manufacturing facilities
  • Distributors, warehouses
  • Own label distributors, private label distributors
  • Packers, Labelers
  • Ingredient suppliers
  • Laboratories
  • Importers

 

For Registrationhttp://www.complianceonline.com/fda-inspection-requirements-seminar-training-80075SEM-prdsm?channel=eventbrite          

 

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

Have questions about Why is FDA at my facility, and what do I do during an inspection?? Contact ComplianceOnline

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When & Where


San Diego

San Diego, CA

Thursday, October 20, 2016 at 8:30 AM - Friday, October 21, 2016 at 4:30 PM (PDT)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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