DUBLIN--(BUSINESS WIRE)--The "Managing Your FDA Inspection: Before, During and After" conference has been added to Research and Markets' offering.
FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, I am here to conduct an inspection. What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert, or a legal action, e.g., civil money penalties, seizure, injunction or prosecution. This course will help you need to know and what you should do to survive an FDA inspection with the least possible pain.
Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA's requirements.
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.
Learning Objectives:
- FDA legal authority to inspect
- Over products
- Over firm's
- Scientific/clinical studies
- Premarket requirements
- Postmarket requirements
- FDA's annual inspection work plan
- Inspection Procedures
- FDA inspection Manuals
- FDA Training
- Documenting violations
- Refusals
- Human factors
- Recall procedures (What FDA expects from you.)
- FDA Field Office Management
- FDA Center(s) Management
- The firm's job
- Inspectional observations (Form FDA-483)
- Responding to a 483
- Responding to a Warning Letter
- Recall procedures (What FDA expects from you.)
- FDA Field Office Management
- FDA Center(s) Management
- The firm's job
- FDA enforcement actions
- Follow up inspections
- Foreign Inspections
For more information about this conference visit https://www.researchandmarkets.com/research/5p7w47/managing_your_fda
