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.
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: $1,000.00 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 of the regulatory requirements for the FDA’s Quality System Regulation (QSR) [specifically 21 CFR Part 820]. The FDA requires employees, contractors, and consultants supporting medical device regulated activities to have sufficient education, training, and experience to perform their assigned functions. Annual QSR 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 sources for QSR
Laws and Regulations.
|•||Module 2:||Fundamentals of “The Act” and the
|•||Module 3:||Understand why we must comply
with the QSR.
|•||Module 4:||Understand who should comply with
|•||Module 5:||Understand what happens if we
don’t comply with the QSR.
|•||Module 6:||FDA Regulations vs FDA Guidelines.|
|•||Module 7:||Fundamentals of the QSR.|
|•||Module 8:||Understand Class I, Class II, & Class III
Device Classifications, 510K, and PMA.
|•||Module 9:||Subpart A – General Provisions.
|•||Module 10:||Subpart B – Quality System
|•||Module 11:||Subpart C – Design Controls.|
|•||Module 12:||Subpart D – Document Controls.|
|•||Module 13:||Subpart E – Purchasing Controls.|
|•||Module 14:||Subpart F – Identification &
|•||Module 15:||Subpart G – Production & Process
|•||Module 16:||Subpart H – Acceptance Activities
|•||Module 17:||Subpart I – Nonconforming Product.|
|•||Module 18:||Subpart J – Corrective and
|•||Module 19:||Subpart K – Device Labeling and
|•||Module 20:||Subpart L – Handling, Storage,
Distribution, and Installation.
|•||Module 21:||Subpart M – Records.
|•||Module 22:||Subpart N – Servicing.|
|•||Module 23:||Subpart O – Statistical Techniques.|
|•||Module 24:||FDA Inspections (In-depth review of
four high risk subsystems):
|•||Module 25:||FDA Inspections and FDA Inspection
Do’s and Don’ts.
All employees, contractors, consultants, and suppliers currently supporting or wanting to support FDA medical device regulated activities:
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 Training™ sales are final.
Do you offer discounts for group pricing?
Yes. Please contact us for special group discount pricing: