Cost-contained regulatory compliance for the pharmaceutical, biologics, and medical device industries /

-д хадгалсан:
Номзүйн дэлгэрэнгүй
Үндсэн зохиолч: Weinberg, Sandy, 1950-
Байгууллагын зохиогч: ebrary, Inc
Формат: Цахим Цахим ном
Хэл сонгох:англи
Хэвлэсэн: Hoboken, N.J. : John Wiley & Sons, c2011.
Нөхцлүүд:
Онлайн хандалт:An electronic book accessible through the World Wide Web; click to view
Шошгууд: Шошго нэмэх
Шошго байхгүй, Энэхүү баримтыг шошголох эхний хүн болох!
Агуулга:
  • Controlling regulatory costs
  • Clear operation definitions of requirements
  • Pre-regulatory audits
  • Quality by design
  • Outsourcing
  • Electronic submissions
  • Emea/fda coordination
  • Managing FDA inspections
  • Risk assessment
  • Cases
  • Cost containment analysis
  • Managing regulation in times of chaos
  • International regulation
  • Cost contained regulatory compliance.