Writing and Managing SOPs for GCP
portes grátis
Writing and Managing SOPs for GCP
Prokscha, Susanne
Taylor & Francis Ltd
10/2024
224
Mole
9781032926735
Pré-lançamento - envio 15 a 20 dias após a sua edição
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FOUNDING PRINCIPLES. Introduction to SOPs. Document Hierarchies. When to Have an SOP. What the SOP Should Say. Where to Put the Output. WRITING, REVIEWING, APPROVING, AND POSTING. Who Writes SOPs? Document A Stable Process. Mapping a New Process. The SOP Template. SOP Review and Approval. Posting: Setting Up for Success. MAINTAINING SOPs; MAINTAINING COMPLIANCE. Deviations from Controlled Procedures. Active SOP Maintenance. HELPING STAFF FOLLOW SOPs. Finding SOPs. Training on SOPs? Department-Managed Documents. ADDITIONAL TOPICS. Where to Start. SOPs during Mergers and Acquisitions. Controlled Glossaries. Example SOP Template. Example SOP of SOPs.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Controlled Document Group;Sop Template;controlled;Sop Author;document;TMF;group;Controlled Document System;clinical;EDC System;data;Controlled Document;management;Ich;system;GCP.;trial;Clinical Data Management;master;Follow;file;Data Management Plan;Contract Research Organizations;Sop Writing;Clinical Trial Management System;Sop Deviation;CRFs;Good Clinical Practice;EDC;Good Clinical Practice Guide;Cross-functional Review;MHRA;Prospective Deviations;Ich E6;Versus
FOUNDING PRINCIPLES. Introduction to SOPs. Document Hierarchies. When to Have an SOP. What the SOP Should Say. Where to Put the Output. WRITING, REVIEWING, APPROVING, AND POSTING. Who Writes SOPs? Document A Stable Process. Mapping a New Process. The SOP Template. SOP Review and Approval. Posting: Setting Up for Success. MAINTAINING SOPs; MAINTAINING COMPLIANCE. Deviations from Controlled Procedures. Active SOP Maintenance. HELPING STAFF FOLLOW SOPs. Finding SOPs. Training on SOPs? Department-Managed Documents. ADDITIONAL TOPICS. Where to Start. SOPs during Mergers and Acquisitions. Controlled Glossaries. Example SOP Template. Example SOP of SOPs.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Controlled Document Group;Sop Template;controlled;Sop Author;document;TMF;group;Controlled Document System;clinical;EDC System;data;Controlled Document;management;Ich;system;GCP.;trial;Clinical Data Management;master;Follow;file;Data Management Plan;Contract Research Organizations;Sop Writing;Clinical Trial Management System;Sop Deviation;CRFs;Good Clinical Practice;EDC;Good Clinical Practice Guide;Cross-functional Review;MHRA;Prospective Deviations;Ich E6;Versus
