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.
- 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?
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.
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:
Current Good Manufacturing Practice
(cGMP) Certification™
[21 CFR Parts 210 & 211]
Online On Demand Training, Click Here!
Pricing: $500.00 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 Current Good Manufacturing Practice (cGMP) [21 CFR Part 210 and 21 CFR Part 211]. The FDA requires employees, contractors, and consultants supporting FDA cGMP activities to have sufficient education, training, and experience to perform their assigned functions. Annual cGMP 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 sources for cGMP Drug Laws and Regulations. |
| • | Module 2: | Fundamentals of “The Act” and the “CFR”. |
| • | Module 3: | Brief history of the Food, Drug, and Cosmetic Act as it applies to cGMP. |
| • | Module 4: | Drug Adulteration, Misbranding, and Violations. |
| • | Module 5: | Fundamentals of cGMP Regulations. |
| • | Module 6: | cGMP Purpose, Enforcement, & Working Knowledge. |
| • | Module 7: | Consumer Safety and Testing. |
| • | Module 8: | The Quality System & cGMP Structure. |
| • | Module 9: | Consent Decree & Cost of FDA Non- Conformance. |
| • | Module 10: | FDA cGMP Regulations vs FDA Guidelines. |
| • | Module 11: | FDA’s Quality System Approach to cGMPs. |
| • | Module 12: | Corporate SOPs written to comply with cGMPs. |
| • | Module 13: | Basic principles of cGMP compliance. |
| • | Module 14: | 21 CFR Part 210. |
| • | Module 15: | 21 CFR Part 211 Subpart A – General Provisions. |
| • | Module 16: | 21 CFR Part 211 Subpart B – Organization and Personnel. |
| • | Module 17: | 21 CFR Part 211 Subpart C – Buildings and Facilities. |
| • | Module 18: | 21 CFR Part 211 Subpart D – Equipment. |
| • | Module 19: | 21 CFR Part 211 Subpart E – Control of Components and Drug Product Containers and Closures. |
| • | Module 20: | 21 CFR Part 211 Subpart F – Production and Process Controls. |
| • | Module 21: | 21 CFR Part 211Subpart G – Packaging and Labeling Controls. |
| • | Module 22: | 21 CFR Part 211 Subpart H – Holding and Distribution. |
| • | Module 23: | 21 CFR Part 211 Subpart I – Laboratory Controls. |
| • | Module 24: | 21 CFR Part 211Subpart J – Records and Reports. |
| • | Module 25: | 21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products. |
Who should take FDA Compliance Training?
All employees, contractors, consultants, and suppliers currently supporting or wanting to support FDA cGMP regulated activities:
- Directors, managers, supervisors
- Engineers
- Auditors
- Manufacturing personnel
- Quality Control personnel
- Quality Assurance personnel
- Quality Management personnel
- Corporate personnel supporting cGMP activities
- Laboratory personnel
- IT personnel
- Buildings and facilities personnel
- Equipment personnel
- Warehouse, holding and distribution personnel
- Personnel supporting the control of components
and drug product containers and closures - Packaging and labeling personnel
- Contractors, consultants, and suppliers
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?
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.
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:
- Up to 10 Users
- Up to 25 Users
- Up to 50 Users
- Up to 100 Users
- Up to 200 Users
- 300 Users or more