The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Regulatory basis for process validation John M. Dietrick and Bernard T. Loftus; prospective process validation Allen Y. Chao F. St Forbes and Reginald F. Johnson; retrospective process validation Chester J. Trubinski; sterilization validation Michael J. Akers and Neil R. Anderson; validation of solid dosage forms Jeffrey S. Rudolph and Robert J. Sepeljak; validation of medical devices Toshiaki Nishihata; validation of biotechnology processes Gail Sofer; transdermal process validation Charlie Neal Jr; validation of lyophilized products Edward H. Trappler; validation of inhalation of aerosols Chris Sciarra and John Sciarra; process validation of pharmaceutical ingredients Robert A. Nash; qualification of water and air handling systems Kunio Kawamura; equipment and facility qualification Tom Peither; validation and verification of cleaning processes William E. Hall; analytical methods validation Ludwig Huber; computer systems validation Tony de Claire; integrated packaging validation Mervyn J. Frederick; analysis of process data using quality control charts Peter Cheng and John Dutt; statistical methods for blend uniformity and dissolution testing Bergum and Utter; change control and SUPAC Nellie H. Waterland and Christopher C. Kowtna; process validation and quality assurance; Carl B. Rifino; validation in contract manufacturing Dilip M. Parikh; terminology on non-aseptic process validation Kenneth G. Chapman; harmonization GMPs and validation Alfred Wachter.
Regulatory basis for process validation John M. Dietrick and Bernard T. Loftus; prospective process validation Allen Y. Chao F. St Forbes and Reginald F. Johnson; retrospective process validation Chester J. Trubinski; sterilization validation Michael J. Akers and Neil R. Anderson; validation of solid dosage forms Jeffrey S. Rudolph and Robert J. Sepeljak; validation of medical devices Toshiaki Nishihata; validation of biotechnology processes Gail Sofer; transdermal process validation Charlie Neal Jr; validation of lyophilized products Edward H. Trappler; validation of inhalation of aerosols Chris Sciarra and John Sciarra; process validation of pharmaceutical ingredients Robert A. Nash; qualification of water and air handling systems Kunio Kawamura; equipment and facility qualification Tom Peither; validation and verification of cleaning processes William E. Hall; analytical methods validation Ludwig Huber; computer systems validation Tony de Claire; integrated packaging validation Mervyn J. Frederick; analysis of process data using quality control charts Peter Cheng and John Dutt; statistical methods for blend uniformity and dissolution testing Bergum and Utter; change control and SUPAC Nellie H. Waterland and Christopher C. Kowtna; process validation and quality assurance; Carl B. Rifino; validation in contract manufacturing Dilip M. Parikh; terminology on non-aseptic process validation Kenneth G. Chapman; harmonization GMPs and validation Alfred Wachter.
Es gelten unsere Allgemeinen Geschäftsbedingungen: www.buecher.de/agb
Impressum
www.buecher.de ist ein Internetauftritt der buecher.de internetstores GmbH
Geschäftsführung: Monica Sawhney | Roland Kölbl | Günter Hilger
Sitz der Gesellschaft: Batheyer Straße 115 - 117, 58099 Hagen
Postanschrift: Bürgermeister-Wegele-Str. 12, 86167 Augsburg
Amtsgericht Hagen HRB 13257
Steuernummer: 321/5800/1497
USt-IdNr: DE450055826
