FDA 2015 - Managing FDA After a Bad Inspection

Overview:
The webinar explains how the FDA conducts an inspection and collects evidence to show you failed to meet one or more regulatory requirement. How you respond to the inspection makes a big difference in the FDA's follow up with you. The agency follows well establish procedures for how it evaluates an inspection and uses a number of factors to determine what action it might take after a bad inspection.. If you understand what the FDA does with your inspection results, you may be able to mitigate the financial and marketing damage. You should understand what your competitors may do after your inspection. They can market your bad decision as soon as the inspection is done.
Why should you attend: You can prepare a strategy to manage the FDA when you have had a bad inspection. You can even use relevant criteria to determine what the FDA might do after you bad inspection. A failure to act on your part digs you into a deeper regulatory pit. The FDA uses a number of criteria when it evaluates a firm's bad inspection, or as the FDA would say, a "violative inspection." At the end of your inspection, you may ask the investigator, "How bad is it?" You will not get an answer. If you understand how the FDA evaluates inspections, you are ahead of the process. If you do not know what you are doing or try to wing it, you will eventually realize that you should have had a strategy already in place before the inspection even started. After a bad inspection, the FDA will hover over you and you cannot afford naïve, short sighted or misguided mistakes. What strategy do you have? What will you say to the FDA after a bad inspection and how can you get yourself off of the FDA's radarscope? If you follow pay attention to specific issues, you can begin to manage the FDA's follow up.
Areas Covered in the Session:
FDA's inspection strategy
The evidence against you
Inspectional List of Observations (Form FDA 483)
Discussions with the FDA (To promise not to promise, that is the question.)
Responding to the 48
Responding to a Warning Letter
FDA verification of corrective action
Who Will Benefit:
Regulatory Affairs Director
Manufacturing Director
Sales and Marketing Manager
Legal Counsel
Product Liability Managers
FDA Consultants
Speaker Profile
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.
Compliance4All
Adam Fleaming
Phone: +1-800-447-9407
Event Link: http://bit.ly/1IIZPOM
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