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FDA/EMEA Joint Inspections: Strategies for Preparation and Success

$357.00
February 2009
978-1-60004-030-6
55
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Now available from FDAnews, this information-packed management report maps out exactly what the new joint inspections mean to your facility — and what you must do now to prepare. Step by step, you’ll learn how to troubleshoot potential problems and align GMPs with both FDA and international rules.

Exclusive information found in no other source! This is your one resource for gaining the insights necessary to ready yourself and your team to respond to both FDA and international inspectors — who themselves come from different backgrounds and have widely varying expectations. 

When you purchase your copy of FDA/EMEA Joint Inspections: Strategies for Preparation and Success, you’ll discover specific strategies for reducing the burden — and risk — of preparing for joint inspections, including:

  • What each agency will be looking for, including technical agreements, written job requirements, transmissible spongiform encephalopathies vulnerabilities, production-floor quality assurance and records previously treated as off limits
  • What regulations each agency will be using to evaluate your operations
  • Who’s in charge of what: Who has lead inspection authority, what format will inspection reports take and who will be responsible for citing deficiencies and hearing appeals
  • How to resolve conflicting agendas: Satisfy the EMEA’s collaborative approach without making your facility vulnerable to FDA inspectors trained to seek out violations and build a case against you
  • The differences among inspectors: Use different strategies to prepare for EMEA officials with five years of industry experience compared with dealing with FDA inspectors who typically come on board right from college
  • Which GMPs and other best practices to follow: Ensure all your operations can stand up to scrutiny from multiple agencies
  • What “small details” make a big difference — for example, having the right translators and enough staff on hand
  • Trends in harmonization between the FDA international agencies: Why joint inspections could ultimately be good for drugmakers

Order now to create GMPs that satisfy the FDA — and the world!

Buy Now!
FDA/EMEA Joint Inspections: Strategies for Preparation and Success. Available in print or PDF format, this invaluable management report is priced at $357 each.

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