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?

Employees, contractors, consultants, and suppliers developing, implementing, using, maintaining, supporting, supplying, managing, or auditing computerized systems in support of FDA regulated GxP and QSR activities:

  • Directors, Managers, Supervisors
  • Engineers
  • IT personnel
  • Validation personnel
  • Auditors
  • Manufacturing personnel
  • Quality and compliance personnel
  • Laboratory personnel
  • Buildings and facilities personnel
  • Equipment personnel
  • Warehouse, Holding and Distribution personnel
  • Packaging and labeling personnel
  • Software vendors
  • Contractors, consultants, 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 & Computer System
Validation (CSV) Basics Certification™


Online On Demand Training, Click Here!

Pricing: $1,200.00 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 Computer System Validation (CSV) Basics. The FDA requires that employees, consultants, and contractors supporting FDA 21 CFR Part 11, GxP, and QSR regulated activities to have the education, training, and experience to perform their assigned functions. Annual 21 CFR Part 11 & CSV Basics training with effectiveness testing improves individual 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: Terms and definitions.
Module 2: Computer System Validation (what is it;
why is it necessary to have a validation
strategy; and core principles).
Module 3: Understand the Validation Life-Cycle.
Module 4: Understand FDA 21 CFR Part 11
regulations for computerized systems:
  • 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 cGMP & QSR regulations
related to computerized systems.
Module 6: Understand Risk-Based Validation.
Module 7: Understand why Computer System
Validation processes vary so much.
Module 8: Common misconceptions about
Computer System Validation.
Module 9: Computer System Validation
compliance challenges.
Module 10: Understand what software requires
validation.
Module 11: Relevant Computer System Validation
FDA warning letters.
Module 12: Overview, fundamentals, and working
knowledge of Validation Master Plan.
Module 13: Overview, fundamentals, and working
knowledge of:
  • GxP Risk Assessment.
  • 21 CFR part 11 Assessment.
  • Validation Plan.
  • Auditing software vendors.
Module 14: Overview, fundamentals, and working
knowledge of:
  • User Requirements
    Specifications.
Module 15: Overview, fundamentals, and working
knowledge of:
  • Functional Specifications.
  • Configuration Specifications.
  • Design Specifications.
Module 16: Understand the Code and
Configuration Phase.
Module 17: Understand the Development
Testing Phase.
Module 18: Overview, fundamentals, and working
knowledge of:
  • Test Plan.
  • Installation Qualification (IQ)
    Protocol and Report.
  • Operational Qualification (OQ)
    Protocol and Report.
  • Performance Qualification (PQ)
    Protocol and Report.
    • Deviation management.
Module 19: Overview, fundamentals, and working
knowledge of the:
  • Requirements Traceability
    Matrix.
  • Validation Summary Report.
Module 20: Understand the Deployment and Use
Phase.
Module 21: Understand Prospective Validation.
Module 22: Understand Retrospective Validation.
Module 23: Understand Security.
Module 24: Understand System Use & Maintenance.
Module 25: Understand Change Control.
Module 26: Understand Incident Management.
Module 27: Understand Periodic Evaluation.
Module 28: Understand Back-up and Restore.
Module 29: Understand Records Retention,
Archiving, and Retrieval.
Module 30: Understand the Decommissioning Phase.


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