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We provide e-books in downloadable PDF format in many different fields to keep you current and save you time. These documents are available across many different fields, including: regulatory guidance, manufacturing and quality compliance regulations, approval process, and relevant Best Practices (GMP, GDP, GCP, GLP, GVP, GPP, GTP, …) in drugs, medical devices, combination products, food & food ingredients, dietary supplements, and complimentary & alternative medicine. They are available for a small fee or free of charge. Simply search by category then browse to find the document you need. New e-books documents are added on a daily basis so please check often.
In this comprehensive e-Book (Good Documentation Practices), the essentials of GDP, its definition, purpose, and importance are explored first, followed by expanding on general rules and principles of GDP (ISO, ICH, FDA, EMA, USP), general tips for Laboratory Notebook documentation, and GDP enforcement by regulatory bodies in different countries with some examples of FDA citations and observations.
In this comprehensive guide (Safety Data Sheets and HazCom 2012 Compliance e-Book), you will learn how to produce or read a safety data sheet. Furthermore, we have included an example for every single section we have discussed to be included in the SDS. We have included a proposed structure for an SDS as well as guidance to assist you in creating a good compliant SDS. We have saved this template in .docx format.
In this 27-page comprehensive guide (Standard Operating Procedure e-Book), you will learn how to produce an effective SOP. We have included a proposed structure for an SOP as well as draft language and other guidance to assist you in creating a good SOP.
This 9-page e-Book (The Basics of Medical Review e-Book) provides a brief explanation on the role of Medical Monitoring and the importance of Medical Monitoring, the minimum items to be included in the SAE Medical Review Form along with a template to enable you to create your own Medical Monitoring Forms.
In this comprehensive guide (21 CFR Part 11 e-Book), Part 11 is discussed since it remains in effect during FDA reexamination period. Also, we elaborate on the latest guidance published in Aug 2003.