FDA regulations information and affordable online GMP training.

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 and provider of affordable online GMP training. We provide Information which outlines ethical and scientific quality standards for designing and conducting operations in an FDA regulated environment. FDA regulations are mandatory standards because they are standards are based on the regulations of the United States Code; collectively, these standards make up the Code of Federal Regulations (CFR). FDARegulatory.com focuses on a critical section of CFR Part 11: Section 820.25: the importance and requirement for highly trained personnel. In the March of 2010, FDARegulatory.com partnered with The Validation & Compliance Institute to provide affordable GMP training which fits any company's budget!

Quick Facts about The Validation & Compliance Institute's Online e-Learning Curriculum:

What is the e-Learning Curriculum? The product is a series of online training courses that teaches employees of the Biotech, Pharmaceutical, and Medical Device industries how to comply with FDA regulations.
How can I access this online GMP training? The training is available to single users or companies. It is available anywhere the internet is accessible.
Is learning verified? A final test provides verification that participants met the course objectives. All participants who pass the final test can print certificates indicating their successful completion of the course.
Can training be tracked? A secure Learning Management System is available for companies. Each employee gets a unique login ID. Training can be tracked by managers and email reminders can be scheduled.
Are the courses effective? Yes. The courses incorporate the experiences of a cross-functional team of developers which includes regulatory experts, adult learning professionals, and experienced industry operations personnel. Feedback from customers has been excellent.

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Discounts and a Learning Management System are available for volume users.

Each company gets its own course catalog. The company can assign a system administrator and every employee who is authorized by the system administrator can individually log into their online GMP training courses at will. The LMS can be configured to track the training and will send emails to warn of impending deadlines to both the employees and managers. The company can configure a wide variety of reports as well. The system supports 21 CFR Part 11 compliance Assigning, scheduling, and monitoring coursework is quick for managers. Taking the courses is minimally invasive for trainees. They can take courses at any time within the timeframe assigned by management. They can start and stop a course as many times as necessary to fit it within their busy schedules.

However, along with that flexibility comes accountability. At the end of each course is a test. The trainees must pass the test at the level set by the company. Good managers know that when learning is verified by testing, excellent performance is one more step closer to reality. We believe that Knowledge + Dedication = Performance. You supply the Dedication. We'll supply the Knowledge.

Structure and Content of the Courses

Our GMP training courses incorporate the experiences of our crossfunctional team of developers. It includes regulatory experts, adult learning professionals, and experienced industry operations personnel who have had to live these regulations while running profitable businesses. In these courses we not only teach the regulatory requirements, but also provide many hints on best practices drawn from our years of operational experience.

Course material is created using adult learning theory to help assure that course objectives are consistently met. Learning games and interactive lessons alternating with quizzes reinforce learning. This web-based GMP training is intensive; not a surface skim that one could simply check off and say that they've been "trained". Real life illustrations enable the participants to relate the concepts to their own jobs. These illustrations, for instance actual examples of documentation, make the material come alive for the students.

Minimum technical requirements for running e-Learning courses:

Microsoft Internet Explorer 7.0 or higher or, Mozilla Firefox 3.0 or higher

Why should you purchase GMP training from us?
Proper GMP Training is a requirement per Title 21 CFR 820.25 as established by the United States Food and Drug Administration. "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."

Answers to Frequently Asked Questions:

What is GMP training and how does it apply to FDA regulations compliance?

GGMP or cGMP refers to the "current Good Manufacturing Practice". The FDA regulates the manufacture of Pharmaceuticals, Medical Devices, Human Foods, Laboratory Practices and various other aspects of how products are developed, manufactured, and distributed. Therefore, following GMP facilitates the ability to adhear to FDA regulations.

A person referring to the "GxPs" is making a reference to all current best practices and their predicate rules. The GxPs include:

Current Good Clinical Practices (cGCP)
Current Good Laboratory Practices (cGLP)
Current Good Manufacturing Practices (cGMP)

What are the predicate rules?

The predicate rules include the follow:

ICH E6 Good Clinical Practices (GCP) - 21 CFR Parts 310,312 and 314
Good Laboratory Practices (GLP) - 21 CFR parts 58
Good Manufacturing Practices (GMP) 21 CFR Parts 210,211
Quality system Practices - 21 CFR Part 820

What is validation?:

A [good] definition of validation: "An on-going process to establish documented, objective evidence which provides a high degree of assurance that a system will consistently meet its predetermined specifications, and will perform repeatedly as intended.

What is the difference between verification and validation?

Wikipedia^® has a great wiki posting to answer this common question. Click here to go to their page on verification and validation.

What is a Validation Master Plan?

The validation master plan is the foundation for a validation program at an organization and includes, but is not limited to, the documentation for defining the following:

Process validation
Facility and utility qualification and validation
Equipment qualification
Cleaning protocols
Computer validation
Software development life cycle (SDLC)

Usage disclaimer: We are not affiliated with, or supported by the FDA. Every attempt is made to provide accurate information and we can not be held liable for any damages resulting from misuse of information or services obtained directly or indirectly from this site. Copyright 2004-2010 FDARegulatory.com. All Rights Reserved. N

An important reminder regarding GMP Training and FDA Regulations

Be reminded: the CFRs and industry guidelines represent a minimum set of requirements for the industry to follow in order to produce a reliable and reproducible product or service throughout the product development lifecycle - so FDA training / GMP training is key! Start preparing yourself for your responsibilities, like taking online GMP training classes with VCI, and keep your training record up to date! In addition to training, please take advantage of our Free FDA Regulations Information Library of information and reference papers to help provide you with the education and proficiency you need to meet FDA regulations compliance requirements.