Managing Your FDA Inspection: Before, During and After

FDA Inspection Training
Copy of GxP Training Seminar
Copy of GxP training
FDA Inspection Training
Copy of GxP Training Seminar
Copy of GxP training

Managing Your FDA Inspection: Before, During and After

1,499.00

June 20-21 2019
San Francisco, CA

The FDA conducts inspections based on well established procedures. You can lower your anxiety level when you can predict what they will do during an inspection, what products they cover and how they will document your problems. Any type of regulated firm should the ground rules of an inspection to keep it under control. You should be able to see the hand writing on the wall if it looks bad and prepare accordingly. You should understand what is at stake based on the progress of an inspection. How you respond to an investigator, to the inspection in general and to the FDA can seal your fate to an unhappy ending if you don’t know what to do, how to do it and how fast you need to do it. Questions are encouraged. What did you want to know about FDA, but were always afraid to ask? What are the big mistakes firms make? Here the firsthand accounts of an ex-FDA investigator.

The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. There should be no surprises if you have prepared properly. Firms need to understand the details about inspectional techniques to avoid making new problems for yourself during the inspection. You can save yourself a lot of corporate misery if you know what to do before, during and after an inspection.

Who will Benefit:

  • Regulatory Affairs

  • Quality Assurance

  • Quality Control

  • Manufacturing

Seminar Fee Includes:

  • Lunch

  • AM-PM Tea/Coffee

  • Seminar Material

  • USB with seminar presentation

  • Hard copy of presentation

  • Attendance Certificate

Quantity:
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Agenda

DAY 01 (8:30 AM - 4:30 PM)

  • Registration Process - (8:30 am till 8:45 am)

  • FDA legal authority

  • FDA inspection plans and risk

  • FDA inspection procedures

  • FDA staff guidance

  • FDA staff training

  • Inspection strategy and technique

  • War rooms

DAY 02 (8:30 AM - 4:30 PM)

  • Documenting violations

  • Collecting “samples”

  • Responding to inspectional observations (FDA Form 483)

  • Responding to a warning letter

  • Legal enforcement actions

  • Recall actions and procedures

  • The field district office

  • The Center(s)

  • The recalling firm

  • Notifying the public

  • Follow up inspections

  • Corrective and preventive actions

  • Foreign inspections

  • Import alert

Andrew Campbell

Speaker:

Casper Uldriks
Former Associate Center Director of FDA’s CDRH

 

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.