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 TrainingT™ 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?
Personnel, contractors, consultants, and suppliers developing, implementing, using, maintaining, supporting, supplying, managing or auditing manufacturing quality systems in support of FDA regulated GMP and QSR activities:
- Directors, managers, supervisors
- Engineers
- Auditors
- Manufacturing personnel
- Quality and compliance personnel
- IT personnel
- Regulatory affairs personnel
- Corporate personnel
- Laboratory personnel
- Warehouse, holding and distribution personnel
- Packaging and labeling personnel
- Contractors, consultants, and suppliers
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:
Manufacturing Quality Assurance
(MQA) Certification™
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:
- Current Good Manufacturing Practice (cGMP) Training
(21 CFR Part 210 and 21 CFR Part 211) - 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 Manufacturing Quality Assurance (MQA) which is essential for the Quality, Purity, Identity, and Safety of FDA regulated products manufactured. The FDA requires employees, contractors, and consultants supporting GMP and QSR activities to have sufficient education, training, and experience to perform their assigned functions. FDA Compliance Training 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: | Introduction and the Quality Management System. |
| • | Module 2: | Management Responsibilities. |
| • | Module 3: | Personnel Qualifications. |
| • | Module 4: | Professional Development and Training. |
| • | Module 5: | Quality Personnel. |
| • | Module 6: | Quality Risk Management. |
| • | Module 7: | Buildings. |
| • | Module 8: | Pest Control. |
| • | Module 9: | Facilities and Utility Systems. |
| • | Module 10: | Periodic Review. |
| • | Module 11: | Cleaning and Sanitization. |
| • | Module 12: | Purchasing. |
| • | Module 13: | Materials Management. |
| • | Module 14: | Warehousing and Storage. |
| • | Module 15: | Clothing and Personal Hygiene. |
| • | Module 16: | Inspection and Testing. |
| • | Module 17: | Sampling. |
| • | Module 18: | Laboratory Controls. |
| • | Module 19: | Test Method Validation. |
| • | Module 20: | Analytical Testing. |
| • | Module 21: | Out of Specifications. |
| • | Module 22: | Atypical Results. |
| • | Module 23: | Stability Program. |
| • | Module 24: | Safety and Pharmacovigilance. |
| • | Module 25: | Quality Plans. |
| • | Module 26: | Equipment Cleaning. |
| • | Module 27: | Equipment Qualification. |
| • | Module 28: | Computer System Validation. |
| • | Module 29: | Process Validation. |
| • | Module 30: | In-Process Controls. |
| • | Module 31: | Data Integrity. |
| • | Module 32: | Preventative Maintenance. |
| • | Module 33: | Calibration. |
| • | Module 34: | Aseptic Operations (Drugs). |
| • | Module 35: | Terminal Sterilization Operations. |
| • | Module 36: | API Operations (Drugs). |
| • | Module 37: | Biologics (Drugs). |
| • | Module 38: | Device Master Records (DMR). |
| • | Module 39: | Device History Records (DHR). |
| • | Module 40: | Medical Device Servicing. |
| • | Module 41: | Environment Monitoring. |
| • | Module 42: | Product Identification and Traceability. |
| • | Module 43: | Manufacturing and Packaging Operations. |
| • | Module 44: | Deviations and Investigations. |
| • | Module 45: | Corrective Action and Preventative Action (CAPA). |
| • | Module 46: | Change Control. |
| • | Module 47: | Documentation and Records. |
| • | Module 48: | Electronic Records and Electronic Signatures. |
| • | Module 49: | Label Controls. |
| • | Module 50: | Batch Release. |
| • | Module 51: | Shipping and Distribution Practices. |
| • | Module 52: | Audits and Self-Inspections (Internal Audits). |
| • | Module 53: | Management of Suppliers and Contractors. |
| • | Module 54: | Contract Manufacturers. |
| • | Module 55: | Complaint Management. |
| • | Module 56: | Recall and Field Action Management. |
| • | Module 57: | Annual Product Quality Review (APQR). |
| • | Module 58: | Management Reviews. |
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 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