Role of Commissioner of Food and Drugs


Book Description




Good Manufacturing Practices for Pharmaceuticals


Book Description

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.







Human Resources Impact


Book Description




Federal Register


Book Description




The Code of Federal Regulations of the United States of America


Book Description

The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.




Code of Federal Regulations


Book Description

Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.




Strauss' Pharmacy Law and Examination Review, Fifth Edition


Book Description

This revised fifth edition maintains and enhances the features that made the previous four best-selling and highly acclaimed editions (formerly entitled Strauss's Pharmacy Law and Examination Review) so popular among pharmacy law faculty, students, and candidates for pharmacist licensing examinations. The book's extensive editorial contents and multiple-choice review questions accurately mirror the subjects and format of the Multistate Pharmacy Jurisprudence ExaminationTM (MPJETM) and state law pharmacist licensing examinations. The editorial matter reflects the need for new and expanded information to keep abreast of legal and regulatory developments. Further, the addition of new and revised graphics and tabulations are intended to focus on important facets of law and retention of the topic.




Pharmaceutical Computer Validation Introduction Guidebook


Book Description

Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and so on. It is also relevant for the medical device, food, and cosmetic industries. 86 pages in the guide include a handy printout of several relevant FDA documents. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version.