BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T222624Z UID:15643bd9-da75-468b-8131-50220c8f6bac DTSTART:20210608T090000 DTEND:20210609T090000 CLASS:PRIVATE DESCRIPTION:\n
*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! **
*
\nREGISTER TODAY! \;
 \;
\n\n \;
\n\nFDA' \;s inspection program follows well-established procedures and conducts th e inspections with as much consistency as possible. FDA trains its investi gators from day one. During the first six months\, they attend extensive c lassroom and hands on training. FDA investigators learn basic skills. As t ime goes on\, special training is given and the field staff use detailed r eference materials to guide their thinking\, actions\, decisions and concl usions. If you understand FDA'\;s management of its investigators and i nspectional process\, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating proc edures and detailed information on how to handle almost any situation the FDA investigator may face. The course will let you see inside an FDA inves tigator'\;s mind set and what the agency will do when it evaluates what the investigator says and documents. What the investigator does and what FDA does are not mysteries\, they just seem like it.
\n\nWe all know that a bad FDA inspection has immediate and long-term consequences. The cost of fixing your problem s\, the bad public relations\, upset customers and future business plans c an be set into a downward spiral. If you do not understand what FDA is doi ng or thinking\, how can you expect to deal successfully with FDA? If you don'\;t know how to anticipate an investigator'\;s actions or follow their train of thought\, you will not be able to mitigate the effect of i nspectional findings.
\n\n" \;Is FDA going to send us a Warning Letter?"\; You can make a reasonab le prediction if you understand your inspectional results and how FDA will "\;grade"\; it. The tools are available.
\n\n \;
\n\n \;
\n\nTypes of Inspections: purpose\, scope and scrutiny
\n\nImpac t on you during and after inspection
\n\nFDA Investigator Training - This is what t hey are thinking
\n\nInvestigations Operations Manua l
\n\nCompliance Programs
\n\nInvestigations Operations Manual (continued)
\n\nMock "\;Limited"\; inspection
\n\nFDA For m 483 - List of objectionable conditions\, aka list of observations
\n\nYour written respon se to a 483
\n\nFDA Warning Letter - advisory of possible legal action
\n\nGroup Hypothetical Warni ng Letter Response - in 10 minutes
\n\nF DA Enforcement Actions
\n\nCasp er (Cap) Uldriks \;owns Encore Insight LLC\, which provides c onsulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA'\;s medical device program as a fiel d investigator\, served as a senior manager in the Office of Compliance an d as an Associate Center Director for the Center for Devices and Radiologi cal Health. He developed enforcement actions and participated in the imple mentation of new statutory requirements. He is recognized as an exceptiona l and energetic speaker. His comments are candid\, straightforward and of practical value. He understands how FDA thinks\, operates and where it is headed.
\n\n \;
\n\n \;
\n\nPlease contact the event manager Marilyn (marilyn.b.turne
r(at)nyeventslist.com ) below for: \;
\n- Discounts for multiple
participants.
\n- Require a price quotation.
\n- Require to pay
by wire transfer or PayPal
\n- Invitation letter for visa application
s
\n
\nNO REFUNDS ALLOWED ON REGISTRATIONS \;
\n-------
----------------------------------------------------------
\nThis Eve
nt is Brought to You by: \;
\nNetzealous LLC - NewYorkEventsList<
br />\nhttp://www.NyEventsList.com
\nhttp://www.BostonEventsList.com<
br />\nhttp://www.SFBayEventsList.com
\n
\nMYL171010CEV
p>\n
\n
\n \;
SUMMARY:Managing Your FDA Inspection: Before\, During and After (ntz)
BEGIN:VALARM
ACTION:DISPLAY
TRIGGER:-PT1H
SUMMARY:Managing Your FDA Inspection: Before\, During and After (ntz)
END:VALARM
END:VEVENT
END:VCALENDAR