Pharmaceutical, Medical Device, Biotechnology firms, and their supply chains are constantly seeking qualified personnel because they are dealing with dynamic corporate changes and regulatory compliance challenges to meet business demands. Highly regulated companies understand there is a strategic competitive advantage when they hire employees, consultants, and contractors with the education, training, and experience needed to facilitate corporate compliance, improve their overall on-the-job effectiveness, and mitigate compliance issues.
Our Web-based Online On Demand FDA Compliance Training™ is developed by highly credentialed industry experts who are uniquely qualified and average over 15 years of hands-on FDA regulated industry quality and compliance experience. Each of our instructors have held senior management positions working for some of the world’s most widely recognizable and trusted pharmaceutical, medical device or biotechnology life science organizations in the world. Each of our course Instructors have real-world experiences representing highly regulated firms during FDA inspections.
All employees, contractors, consultants, and supplierscurrently supporting or wanting to support FDA cGMP audit and Inspection activities:
Our global cGMP, Medical Device, and Supplier Quality Auditing services are backed with a 100% money back guarantee. Simply put, if you’re not satisfied with the quality of our auditing services, we will refund your money. Call us Today!
Pricing: $2,000.00 per person
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About the Course:
This Web-based Online On Demand FDA Compliance Training™ course (accessible for 90 days from the purchase date) provides a comprehensive overview, FDA regulatory knowledge, and working knowledge of 21 CFR Part 11 and FDA Auditing of Computerized Systems. The FDA requires employees, contractors, and consultants supporting FDA 21 CFR Part 11, GxP, and QSR regulated activities to have sufficient education, training, and experience to perform their assigned functions. Annual 21 CFR Part 11 & FDA Auditing of Computerized Systems training with effectiveness testing improves individual contributor working knowledge, skills and effectiveness; helps to proactively reduce regulatory risks; and facilitates FDA compliance. Investing in FDA Compliance Training is essential to the qualifications, growth, and success of any individual wanting to support FDA regulated activities. All participants will receive a Certificate of Training upon successful completion.
|•||Module 1:||Understand the FDA regulatory
framework for computerized systems
supporting GxP and QSR activities for:
|•||Module 2:||Understand common industry
21 CFR Part 11 misconceptions.
|•||Module 3:||Understand why Computer System
Validation processes vary so much.
|•||Module 4:||Understand FDA auditing against 21
CFR Part 11 criteria:
|•||Module 5:||Understand industry compliant
Validation standards for Electronic
|•||Module 6:||Understand key elements of FDA
expectations for Electronic Record
System Data Integrity.
|•||Module 7:||Relevant Computer System Validation
FDA warning letters.
|•||Module 8:||Understand procedural controls governing
Computer System Validation operational
|•||Module 9:||Understand key elements of the
Validation Master Plan (VMP).
|•||Module 10:||Understand key principles of Computer
|•||Module 11:||Understand FDA Auditing of
Computerized Systems supporting
GxP and QSR regulated activities:
|•||Module 12:||Understand change control and
|•||Module 13:||Understand how to audit software and
technology vendors for 21 CFR Part 11
|•||Module 14:||Understand how to avoid FDA 483s
related to Electronic Record / Electronic
|•||Module 15:||Understand Inspection Readiness for
Electronic Record / Electronic Signature
We provide Web-based Online On Demand FDA Compliance TrainingTM certifications for employees, consultants, and contractors currently supporting or wanting to support FDA regulated activities for pharmaceutical, medical device, biotechnology, and related supply chain firms. All training course certifications have been developed by a committee of highly credentialed industry experts who are FDA Compliance Specialists and average over 15 years of hands-on FDA regulated industry quality and compliance experience. There is no formal application process and no extra cost above standard training course fees.
Frequently Asked Questions:
How do I register for an FDA Compliance Training course?
There are two ways to register for the training course.
You may click on Register
at the top of the page to enroll using a credit card via this website or, you may call our office at +1 (212) 884-0333 to enroll by telephone.
To register for a training course, you must pay for the course in full, or be approved for direct invoice. Payment in full is required before any Web-based Online On Demand FDA Compliance Training™ is provided.
After I register for a training course, how long will I have
to access the training course?
The Web-based Online On Demand FDA Compliance Training™ will be available for 90 days from the purchase date.
Do I need to download software to participate?
No. The training is provided by a secure, Online On Demand Web Based Learning Management System as long as you have a standard internet browser to access the course.
What is your cancellation policy?
Because of development and infrastructure costs, highly competitive pricing, and exceptional content that will be made available after the purchase, all Web-based Online On Demand FDA Compliance TrainingTM sales are final.
Do you offer discounts for group pricing?
Yes. Please contact us for special group discount pricing: