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Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
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![](/rcimages/rc200big.jpg) (Buch) |
Dieser Artikel gilt, aufgrund seiner Grösse, beim Versand als 3 Artikel!
Lieferstatus: |
i.d.R. innert 14-24 Tagen versandfertig |
Veröffentlichung: |
Oktober 2019
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Genre: |
Wirtschaft / Recht |
ISBN: |
9780367394769 |
EAN-Code:
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9780367394769 |
Verlag: |
CRC Press |
Einband: |
Kartoniert |
Sprache: |
English
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Dimensionen: |
H 226 mm / B 152 mm / D 38 mm |
Gewicht: |
907 gr |
Seiten: |
704 |
Bewertung: |
Titel bewerten / Meinung schreiben
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Inhalt: |
A guidebook to FDA compliance, this text lists the necessary steps for meeting compliance requirements during the drug development process. Presenting comprehensive approaches for validating analytical methods for pharmaceutical applications, it covers important compliance and quality systems used in the FDA-regulated industries related to medical devices, pharmaceuticals, and biologics. The book includes topics such as validating analytical methods for pharmaceutical applications, stability testing, computer validation, vendor qualification, internal audit programs, and strategic planning for compliance and regulatory defensiveness. |
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