Online GMP Training - FDA Regulations Compliance Solutions
Meet the United States Food and Drug Administration's compliance requirements for education [ 21 CFR 820.25] using affordable resource like e-learning GMP training packages. Our suggested training materials will not only continue to be in compliance with 820.25, they will also prepare you for audits relating to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practice (GLP), medical devices, and the required validation of electronic records and signatures systems - 21 CFR Part 11.
Welcome to THE Internet's most concise free resource of FDA regulations compliance information. WE help you to continue to Meet FDA regulations requirements for education [ 21 CFR 820.25 ] by finding, reviewing and providing affordable resources like interactive GMP training SOFTWAR, GMP related books and nook® e-books.
Since its inception in 2004, FDARegulatory.com has had one primary objective: be the Internet's most concise free resource of FDA regulations compliance information. In addition to recommending FDA compliance resources, we provide a Free FDA Regulations Information Library - a collection essential documents which outline ethical and scientific quality standards for designing and conducting operations in an FDA regulated environment. FDA regulations are mandatory standards because they are based on the regulations of the United States Code; collectively, these standards make up the Code of Federal Regulations (CFR). Our focus is on this section of the CFR: "Title 21 CFR 820.25 - Personnel. (a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed." Through the use of our suggested reading material and affordable, all inclusive e-learning software, you can be compliant without spending a small fortune.
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"Widely used and accepted GMP training book which covers 21 CFR Part 11, Pharmaceutical Computer Validation Introduction, and Pharmaceutical Quality Control Lab. These three courses will give an excellent introduction to the most important areas of pharmaceutical manufacturing. When you successfully complete the exam, you will receive a certificate of completion that will demonstrate your mastery of this topic and provide documentation of GMP training... more
Investigations Operations Manual: FDA Field Inspection and Investigation Policy and Procedure Concise Reference
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 operations regulated by the Food and Drug Administration. more
Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance. Covering Title 21 of the Code of Federal Regulations (CFR) Part 11 and the parallel, recently passed Title 45 CFR Parts 160, 162, and 164 of the Health Insurance Portability and Accountability Act ... more
Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP
"Quality System requirements for medical have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983, and were instituted as requirements in a final rule published on October 7, 1996. source: Wikipedia . more
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