Geben Sie die erste Bewertung für diesen Artikel ab
A step-by-step guide based on real-world examination experience. Discover how to document process validation in a way that is sure to satisfy — and impress — regulators!
Lieferung sofort nach Zahlungseingang
345,00 € netto
Excerpt from the GMP Compliance Adviser Few things in drugmaking are as challenging as process validation — nor as likely to trip you up with FDA inspectors. Hundreds of individual manufacturing processes to validate. And the most common mistakes occur after the work of validation has taken place: when documenting the work to show that it’s been done. What validation method should you use? Who should be involved in validation? When should you conduct the validation? You are beyond the introduction to process validation and ready to get straight to the heart of the matter. Managing Process Validation: A Drugmaker’s Guide — written by pharma industry veteran and GMP specialist, Dr. Christine Oechslein — gives you the information you need to craft a solid validation program, including:
Order Managing Process Validation: A Drugmaker’s Guide and gain the confidence to conduct process validations that reduce risk and satisfy regulators. BONUS feature: Detailed sample documents to adapt to your specific manufacturing situations: - Sample Validation Master Plan: includes scope of plan, key terms, validation policy, organization responsibilities, and more - Validation Matrix: featuring table listing key details of each validation project in the master plan
Bitte geben Sie die Zeichenfolge in das nachfolgende Textfeld ein.
This file is in PDF format!Filesize: 1,5 MB
To view PDF files, we recommend using the Adobe Reader.
If you choose payment by bank transfer:
If you choose payment by credit card:
59,00 € netto
87,00 € netto
117,00 € netto
49,00 € netto
345,00 € netto
179,00 € netto
321,00 € netto
169,00 € netto
189,00 € netto
0,00 € netto
75,00 € netto
129,00 € netto
34,90 € netto
219,00 € netto
Various different aspects must be considered in order to transfer documentation management,...
A qualification serves to prove that equipment is fit for its given purpose. So far, so good....
Do your validation processes meet their specified requirements? This bilingual guide offers an...
Lesen Sie GMP-News und informative Beiträge zum Thema GMP in unseren kostenlosen GMP Newsletter "LOGFILE".
Bitte wählen Sie Ihre Währung aus