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DTSTAMP:20260413T024922Z
SUMMARY:FDA Inspections – Do's and Don'ts
DESCRIPTION:Overview: \nMost federal laws concerning the FDA are part
  of the Food, Drug and Cosmetic Act which are codified in Title 21 of
  the United States Code. However, the language in the law and regulati
 ons is often very vague and difficult to interpret. Hence, FDA inspect
 ions often result in observations and compliance actions that cost man
 ufacturers and marketers of FDA regulated products hundreds of hours a
 nd sometimes millions of dollars to address to the satisfaction of the
  agency.\nWhy should you Attend: If you are looking for answers to th
 ese questions, you would certainly benefit by attending this seminar o
 n managing FDA inspections:\n\nHow can your company be prepared for an
  FDA inspection?\nHow should your company respond to a 483 or warning 
 letter correctly the first time without hiring a costly law firm?\nWha
 t can an FDA inspector legally ask for during an inspection and what c
 an you refuse to show the investigator?\n\nWell, the answers to these 
 and many, many more typical questions are now available in a simple to
  understand yet detailed training session designed to help manufacture
 rs of FDA regulated products prepare for, manage, and follow up on ins
 pections. Areas Covered in the Session:\n\nDefine the steps necessary
  to prepare for an FDA inspection\nDiscuss details surrounding the man
 agement of inspections from announcement to close out meeting\nOffer r
 esponses to FAQs regarding typical inspector requests during inspectio
 ns\nDefine the methodology for responding to 483 and warning letters\n
 Discuss common pitfalls to avoid during an inspection\nDefine the step
 s necessary to prepare for an FDA inspection\nDiscuss details surround
 ing the management of inspections from announcement to close out meeti
 ng\nOffer responses to FAQs regarding typical inspector requests durin
 g inspections\nDefine the methodology for responding to 483 and warnin
 g letters\nDiscuss common pitfalls to avoid during an inspection\nDefi
 ne the steps necessary to prepare for an FDA inspection\n\nCompliance4
 AllAdam FleamingPhone: +1-800-447-9407 support@compliance4all.comwww.c
 ompliance4all.comEvent Link :http://www.compliance4all.com/control/w_p
 roduct/~product_id=500470LIVE/\n\nFor more information visit https://m
 edtechiq.ning.com/events/fda-inspections-do-s-and-don-ts
DTSTART;TZID=America/New_York:20150925T100000
DTEND;TZID=America/New_York:20150925T110000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 0470LIVE/
URL:http://www.compliance4all.com/control/w_product/~product_id=500470
 LIVE/
CONTACT:8004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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