FDA Regulations and Associated Guidance Documents: - Part 11 Electronic Records; Electronic Signatures - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community - Part 200 Drugs General - Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution - Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs - Part 211 Current Good Manufacturing Practice...

This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.

FDA Acronyms, Abbreviations and Terminology provides a quick reference to the acronyms, abbreviations and definitions related to Food and Drug Administration (FDA) human and veterinary products regulatory activities. The emphasis for this reference guide is on scientific, regulatory, government agency, computer application terms, and includes some FDA organizational and program acronyms. Definitions from Title 21 of the United States Code have been included because of their relevance to FDA activities.

The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents. The IOM is recommended reading for all...

The United States Navy Basic Military Requirements have long been the standard used as the pinnacle of training achievement. This manual has been continuously tested and updated to successfully educate every member of the Navy since its inception. The needs of the instructor, the student, and the Navy are perfectly balanced. Whether you are planning to join the Navy, have served in the Navy, or plan to use the BMR as a template for training material development, this book is for you. This is the model all educators should follow when developing training programs and course materials.

Part I: Food and Drugs Act - Part A: Administration - Part C: Drugs Division 1 - Division 1A: Establishment Licences - Division 2: Good Manufacturing Practices Part II: Guidance Documents Part III: Annexes to the Current Edition of the Good Manufacturing Practices (GMP) Guidelines Part IV: Questions and Answers Part V: International Conference on Harmonisation (ICH) Guidance Documents - ICH Q1A(R2): Stability Testing of New Drug Substances and Products - ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products - ICH Q1C: Stability Testing for New Dosage Forms -...

ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation Q2(R1)] * Part III: Impurities Q3A(R2), Q3B(R2), Q3C(R4)] * Part IV: Pharmacopoeias (List Overview) * Part V: Quality of Biotechnological Products Q5A(R1), Q5B, Q5C, Q5D, Q5E] * Part VI: Specifications Q6A, Q6B] * Part VII: Good Manufacturing Practice Q7] * Part VIII: Pharmaceutical Development Q8(R2)] * Part IX: Quality Risk Management Q9] * Part X: Pharmaceutical Quality System Q10] Reference Tools * Part XI: Questions and Answers for...

Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a refresher. While the specific regulations and requirements may differ widely between pharmaceutical, biotechnology, medical device, and food manufacturers, the inspection processes and procedures do not.

Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality...

The United States Army is recognized internationally as the standard for complete, efficient and effective adult education. The Army has a tradition of pioneering training systems (including computer-based training) that then transition into the corporate sector. This manual has been continuously tested and updated to successfully educate every member of the modern United States Army. The needs of the instructor, the student, and the Army are perfectly balanced. This is the model all educators should follow when developing and delivering training programs. This book is Volume 1 of a 2 volume...