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?

Who should take FDA Compliance Training?

All employees, contractors, consultants, and suppliers currently supporting or wanting to support medical device audit program activities:

  • Directors, Managers, Supervisors
  • Engineers
  • Auditors
  • Manufacturing personnel
  • Quality Control personnel
  • Quality Assurance personnel
  • Quality Management personnel
  • Corporate personnel
  • Laboratory personnel
  • Equipment personnel
  • Warehouse, Holding and Distribution personnel
  • Personnel supporting the control of components
    and drug product containers and closures
  • Packaging and labeling personnel
  • All personnel, contractors, and consultants


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.


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:

Certified Medical Device Quality Auditor™


Online On Demand Training, Click Here!

Pricing: $1,500.00 per person

I Have Read and Agree to Terms of Services

Pre-requisites for this course are:

  1. Quality System Regulation (QSR) Training
    (21 CFR Part 820).

  2. Good Documentation Practices (GDP) Training.

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 and working knowledge of Medical Device Quality Auditor Training. All phases of the audit process are covered to provide the knowledge, skills, and tools needed to be a Medical Device Quality Auditor. The FDA requires employees, contractors, and consultants supporting FDA QSR activities to have sufficient education, training, and experience to perform their assigned functions. Annual Medical Device Quality Auditor 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: Audit terms and definitions.
Module 2: Understand the different phases
and activities of the quality system
audit.
Module 3: Independence of the audit function.
Module 4: Understand the audit team leader.
Module 5: Understand the importance of selecting
the right audit team members.
Module 6: Roles and responsibilities of the
auditor and the auditee participants.
Module 7: Auditor conduct, professionalism,
personal behavior, and ethics.
Module 8: Understand the audit purpose, audit
scope, audit objectives, and audit
criteria.
Module 9: Understand audit scheduling, pre-
audit requests and activities, audit
preparation, audit logistics, and
coordination.
Module 10: Understand the audit notification
letter.
Module 11: Understand the audit plan, effective
resource utilization, and reviewing
the audit plan with the auditee.
Module 12: Understand the importance of
traceability with the audit report in
accordance with the audit plan.
Module 13: Understand audit checklists.
Module 14: Understand the audit agenda for
effectiveness.
Module 15: Understand how to conduct an
opening meeting, audit management,
and establishing transparent
communication.
Module 16: Conducting a site tour.
Module 17: Sampling of records and documents
to verify QSR compliance.
Module 18: Documenting the audit activities.
Module 19: Conducting effective interviews and
conflict resolution.
Module 20: Understand how to document clear,
complete, defendable audit
observations with objective
documented evidence.
Module 21: Understand the Pre-daily wrap-up
meeting with the audit team.
Module 22: Understand the daily wrap-up
meeting with the auditee.
Module 23: Understand the final audit debrief /
Close out for effectiveness.
meeting with auditee.
Module 24: Audit report development and
compliance with audit process
requirements.
Module 25: Understand combining similar audit
observations for the audit report.
Module 26: Understand critical elements for
documenting defendable audit
observations on the audit report.
Module 27: Review and approval of the audit
report.
Module 28: Confidentiality and controlled
distribution of the audit report.
Module 29: Audit certification.
Module 30: Reviewing the audit response and
action plan for acceptance.
Module 31: CAPA management.
Module 32: Revisit the auditee and follow-up.
Module 33: Verification of audit response
action plan completion for audit
closure.
Module 34: File retention and audit metrics.
Module 35: Revisit the auditee and follow-up.
Module 36: Verification of audit response
action plan completion for audit
closure.
Module 37: File retention and audit metrics.


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