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.
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:
Pricing: $500.00 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 and working knowledge of Good Documentation Practices (GDP). Good Documentation Practices are critical to ensure quality, compliance, data integrity, and safety of drug and medical device products sold to patients and consumers. The FDA requires employees, contractors, and consultants supporting GxP and QSR activities to have sufficient education, training, and experience to perform their assigned functions. Annual GDP 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:||Introduction to Good Documentation
|•||Module 2:||The purpose of Good Documentation
|•||Module 3:||The importance of Good
|•||Module 4:||Personnel responsibilities.|
|•||Module 5:||FDA expectations for documentation
|•||Module 6:||Recording information.|
|•||Module 7:||Document signatures, initials, date,
|•||Module 8:||Signature authority.|
|•||Module 9:||Date formats.|
|•||Module 10:||Data and information.|
|•||Module 11:||Incorrect entries and corrections.|
|•||Module 12:||Objective evidence.|
|•||Module 13:||Not applicable (N/A) entries.|
|•||Module 14:||Data transcription.|
|•||Module 15:||Common documentation errors to
|•||Module 16:||Good Documentation Practices
|•||Module 17:||Documentation maintenance.|
|•||Module 18:||The importance of data integrity
and good documentation.
|•||Module 19:||Documentation practices that are
unacceptable by the FDA.
|•||Module 20:||FDA 483 observations related to
Good Documentation Practices.
|•||Module 21:||Your role in maintaining Good
|•||Module 22:||Summary of critical principles
related to Good Documentation
All employees, contractors, consultants, and suppliers currently supporting or wanting to support FDA regulated activities for pharmaceutical, medical device, biotechnology firms, and their supply chains:
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!