Download or read book Linguistics and Psychoanalysis written by Michel Arrivé and published by John Benjamins Publishing. This book was released on 1992 with total page 195 pages. Available in PDF, EPUB and Kindle. Book excerpt: between linguistic and psychoanalytic concepts necessarily arises. Until now this question has been examined mainly by psychoanalysts, from their own perspective, but here it is investigated by a linguist, who systematically explores two domains. The first is related to the sign and symbol, where the meeting of Freud, Saussure and Hjelmselv occurred; whereas in the second, that of the signifier, Saussure reappears escorted by Lacan. But Freud is not far away, since the.

Download or read book Cleaning Validation Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2010-05-24 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on a CD-ROM to enable users to amend or adopt them as necessary. Grounded in practicality, the book’s applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

Download or read book La m thode de calcul des Limites R siduelles Acceptables un pilier de l optimisation de la strat gie de la validation de nettoyage dans l industrie pharmaceutique written by Fanny Dupuy and published by . This book was released on 2024 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dans l'industrie pharmaceutique, le nettoyage représente un pilier fondamental dans la lutte contre les contaminations des produits fabriqués. Afin d'évaluer l'efficacité de cette opération la stratégie de validation de nettoyage est particulièrement importante. Cela passe notamment par le choix de seuils d'acceptation adaptés et pertinents (prise en compte de la Permitted Daily Exposure (PDE), de la surface réelle des équipements...). Ce travail expose donc dans un premier temps, les différents modes de contamination et les différents moyens mis en œuvre pour les éviter. Puis, il détaille les pré requis à la validation de nettoyage ainsi que ses diverses étapes. Pour finir, il présente un exemple concret d'optimisation de stratégie de validation de nettoyage via le calcul de nouvelles Limites Résiduelles Acceptables (LRA) et le choix de nouveaux critères d'acceptation.

Download or read book Validated Cleaning Technologies for Pharmaceutical Manufacturing written by Destin a LeBlanc and published by CRC Press. This book was released on 2019-08-30 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.