Competitive Advantage:

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.


What differentiates our FDA Compliance Training?


  • We provide exceptional, value-added, cost-effective, easily accessible Web-based Online On Demand FDA Compliance Training™ (available for 90 days from the purchase date).
  • Our training content is developed by FDA Compliance Specialists with over 15 years of FDA regulated quality and compliance experience.
  • Our training is deployed on a secure, reliable, Learning Management System, powered by Sun Enterprise servers, located in a secure facility, with redundant hardware, power, and internet connections.
  • Our Learning Management System is easy to use and offers the flexibility to train anytime, anywhere, as long as you have a standard internet browser.
  • To ensure each participant is sufficiently trained and our training is effective, there are test questions for each training module. Upon successful completion of the course, a Training Certificate is provided as documented evidence for your training records.
We provide exceptional training for less money:
  • Why pay extra money for membership fees?
  • Why pay extra money for third party training
    certification that is not required by the FDA?
  • Why pay extra money for expensive reference
    books that are not required by the FDA?
  • Why pay extra money for exam preparation
    materials that are not required by the FDA?
  • Why pay extra money to take the exam?
  • Why pay extra money to re-take the exam if you
    fail to pass the exam?
  • Why pay extra money for airfare, car rental, and
    hotel expenses to attend training?
  • Why pay extra money for inferior content?
Course Instructor:

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.


Who should take FDA Compliance Training?

All employees, contractors, consultants, and suppliers currently supporting or wanting to support FDA cGMP audit and Inspection activities:

  • Directors, Managers, Supervisors
  • Engineers
  • IT Personnel
  • Validation personnel
  • Auditors
  • Quality and compliance personnel
  • Laboratory personnel
  • Buildings and facilities personnel
  • Equipment personnel
  • Warehouse, Holding and Distribution personnel
  • Packaging and labeling personnel
  • Software vendors
  • All personnel, contractors, and suppliers

Health Care

FDA Compliance Specialists on Demand:

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!


FDA Compliance Specialist:

21 CFR Part 11 & FDA Auditing of
Computerized Systems Certification™


Online On Demand Training, Click Here!

Pricing: $2,000.00 per person


I Have Read and Agree to Terms of Services

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.


Course Content:

Module 1: Understand the FDA regulatory
framework for computerized systems
supporting GxP and QSR activities for:
  • Quality Management Systems
  • Storage & Distribution Systems
  • Laboratory Systems
  • Product Testing Systems
  • Production Systems
  • Packaging Systems
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:
  • Validation
  • Education, Training, & Experience
  • Security
  • Protection of records
  • Audit trails
  • Operational System Checks
  • Authority Checks
  • Input Checks
  • Policies for using electronic signatures
  • Accurate and complete copies of records
  • Document Control
Module 5: Understand industry compliant
Validation standards for Electronic
Record Systems.
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
activities.
Module 9: Understand key elements of the
Validation Master Plan (VMP).
Module 10: Understand key principles of Computer
System Validation.
Module 11: Understand FDA Auditing of
Computerized Systems supporting
GxP and QSR regulated activities:
  • Validation Plans.
  • Risk Assessments.
  • User Requirements
    Specifications.
  • Functional Requirements Specifications.
  • Design Specifications.
  • Code and Configuration activities.
  • Test Plans.
  • Installation Qualification (IQ)
    Protocols and Reports.
  • Operational Qualification (OQ)
    Protocols and Reports.
  • Performance Qualification (PQ)
    Protocols and Reports.
    • Deviation management.
  • Requirements Traceability Matrix.
  • Validation Summary Reports.
Module 12: Understand change control and
configuration management.
Module 13: Understand how to audit software and
technology vendors for 21 CFR Part 11
capabilities.
Module 14: Understand how to avoid FDA 483s
related to Electronic Record / Electronic
Signature systems.
Module 15: Understand Inspection Readiness for
Electronic Record / Electronic Signature
Systems.


Certifications:

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:

  • Up to 10 Users
  • Up to 25 Users
  • Up to 50 Users
  • Up to 100 Users
  • Up to 200 Users
  • 300 Users or more