Preparing for an FDA Inspection - Webinar CD/Transcript

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Preparing for an FDA Inspection: 16 Simple Steps to Take Today

Athletes go over their plays until they become second nature. So, by the time they're facing their opponent on the field, it's 'showtime.'

Your employees need the same kind of training and rehearsing to fine-tune their FDA investigator playbook.

Sure, you have all the logistics nailed down.  But how well prepared is your team to interact with FDA investigators?

The day the phone rings, announcing "the date," you'll have to already BE prepared! That takes practice.

We invited John Avellanet, an award-winning FDA compliance expert, to give you step-by-step advice on how to put your best foot forward prior to an inspection and understand the actions to take during and after the closeout meeting. 

You will discover:

  • How an FDA investigator prepares for an inspection … and how to take advantage
  • Workflow of the inspection — from the FDA’s perspective
  • Impact of FDASIA’s and remote inspections
  • Specific inspectional questions to be prepared to answer
  • 13 records to have immediately available — and ready to send to the investigator prior to arrival
  • 16 Do’s and Don’ts during the opening and closeout meetings that have caused 483s
  • 3 core members of a modern inspection handling team
  • Hidden 483s lurking in your records today
  • 7 steps to immediately take upon FDA notification of an inspection

This one-of-a-kind 90-minute webinar CD and transcript can help you turn an FDA inspection nightmare into a dream! 

The manner in which these inspections are handled can have a major impact on the results. The appropriate handling of inspections can affect the timing of approvals and may mean the difference in whether the agency takes a regulatory action or grants a product approval.

In just 90-minutes, have your team ready for game time.

  • Compliance officers
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • Regulatory/legislative affairs professionals

Meet Your Presenter
John Avellanet is the author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (2010, Logos Press), and founder of the FDA compliance consulting firm, Cerulean Associates LLC. Prior to founding Cerulean, Mr. Avellanet was a former Fortune 500 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, FDA, DEA, and HIPAA compliance. During his career, he had to defend decisions to inspectors, auditors, and litigators alike. John is also an expert member of the ISPE Data Integrity Working Group. He now brings that real-world experience and practical advice to his consulting clients, his articles, and his speeches.