© CERULEAN ASSOCIATES LLC

Bulletproof Yourself against FDA Enforcement

$ 349.00

Category:

Description

Summary

Since 2009, FDA’s enforcement budget has increased by $1.5 billion for more inspections and more prosecutions.  FDA warning letters, product seizures, and consent decrees have increased as a result – even though company personnel thought they had a good quality system in place.

You can protect yourself.  First, you need to know what the FDA is scrutinizing.  Second, you have to know how FDA’s expectations of your compliance infrastructure have changed.  And third, you need to prepare your personnel on how to handle the inevitable inspection while encouraging a positive closeout.  This recorded seminar will show you how.

Learning points

  • What hot button items FDA is scrutinizing through 2012
  • Five keys to successfully responding to 483s in 15 days or less
  • How to determine if your firm is attracting undue agency attention
  • Triggers of pre-approval inspections (PAIs) and steps to avoid
  • Warning letter citation trends
  • What FDA inspectors look for when examining CAPA processes
  • The #1 question every inspector will ask about your supplier qualification program that will result in an FDA Form 483 if you get wrong
  • What supplier due diligence aspects investigators look for
  • How to quickly distinguish between critical compliance needs versus “nice-to-have’s”
  • A practical, eight-step inspection preparation process
  • A detailed action plan to prepare for, handle and monitor, and then follow-up from an inspection

And much more

Get 15+ documents for easy & quick implementation

  • Checklist:  Inspection preparation
  • Checklist:  Inspection handling and closeout
  • Checklist:  Form 483 responses
  • Checklist:  FDA enforcement priority review self-assessment
  • Sychronized audio-visual recording
  • Slides with room for your own notes
  • Customizable training certificate
  • FDA presentation on how to effectively respond to 483 observations:  Anita Richardson, Writing an Effective 483 Response
  • FDA presentation on quality systems compliance expectations:  Mary Malarkey, FDA Compliance Update: Quality Systems
  • FDA presentation on international compliance expectations:  Jan Welch, Recent Developments in the International Compliance Landscape – a US FDA Perspective
  • FDA presentation on GCP inspection processes:  Jean Toth-Allen, Anatomy of a GCP Inspection
  • FDA presentation on GMP quality system enforcement actions:  Joe Famulare, Effective Pharmaceutical Quality Systems – A Regulatory Perspective
  • Article case study:  17 Lessons from the KV Pharma Consent Decree
  • 13 different FDA warning letters representative of key inspectional trends and compliance expectations

And more

How it works

Either purchase the recorded seminar in an immediately available digital download format or request an invoice and the CD shipped to you within 10 business days.

Note: CD will be shipped after payment has been received. See our Better Business Bureau-accredited online purchasing and return policy for questions.

More benefits

  • Efficiency:  Elimination of travel means more affordable advice
  • Productivity:  Rely on technology tools to view the recorded seminar and get the reference materials
  • Veteran expertise:  Complement the seminar with a confidential teleconsulting session for further questions specific to your situation
  • Environmentally sound:  Spare our environment with less travel and a digital download