“Real Voices. Real Experts. Real Learning.”

FDA GMP Quality Online Training

Navigating FDA regulations can be complex.

BatchWize Training provides introductory to beginner-level training that helps you understand what it takes to bring products to market and maintain their success.

20+ years of industry experience

Available Courses

Graphic with the title '5 steps to FDA approval' showing a pathway with steps marked by dice and a small running figure.
5 Steps to FDA Approval
Free

FDA Product Approval is a necessary journey if you want to market, sell, or distribute regulated products in the United States. These regulations apply equally to U.S. and Non-U.S. Companies. This free course provides a high level roadmap for getting started with your FDA approval process.

✓ 20 minutes of curated content
✓ Understand what it means to be "FDA Approved"
✓ Learn where to look for submission information
Close-up of a person holding a puzzle piece labeled 'RULES' fitting into a puzzle labeled 'REGULATION', with a green and brown background and text indicating 'MODULE 2' of a course on Code of Federal Regulations.
Module 2: CFRs & Products Regulated by FDA
$89.95
One time

Learn about the United States Code of Federal Regulations (CFRs) as they apply to regulated products including drugs, devices, tobacco & food. Understand how the FDA classifies products.

✓ Learn about U.S. FDA Regulations
✓ Tips on how to navigate federal requirements
✓ Understand how the FDA classifies products
A person holding a pink gift box with a brown ribbon, alongside a green and pink promotional graphic for a bundle deal on modules and bonus material, with a gold badge that says 'Best Value'.
Modules 1-4 + BONUS
$299.95
One time

*Best Value* This four course bundle includes full access to Module 1, Module 2, Module 3, and Module 4, plus bonus material! This course bundle is perfect for beginning or intermediate levels.

✓ Clear Understanding of FDA regulations
✓ Learn to navigate regulatory requirements
✓ Includes Drugs, Medical Devices, Food & Beverage
Person using a calculator with cash and a pen on a wooden table, alongside a notebook and a receipt, representing financial calculation or budgeting.
Module 3: The Cost of Noncompliance with U.S. FDA
$89.95
One time

What happens if I don't comply with FDA? This module discusses the regulatory and legal tools available to the FDA and the consequences companies may experience if they do not comply.

✓ Understand "noncompliance" as applied by FDA
✓ Regulatory, financial & business consequences
✓ Discuss important considerations for any product
A person in a brown sweater typing on a laptop at a wooden table, with a green and white course slide on the left side labeled 'Module 1' and 'The United States FDA.'
Module 1: The U.S. FDA
$89.95
One time

Learn the fundamentals of the U.S. Food & Drug Administration. This course includes the history of the FDA, the FDA organizational structure, & a discussion of the FDA's scope and jurisdiction.

✓ History of the U.S. FDA
✓ FDA scope and jurisdiction
✓ Fundamentals everyone should know!
Scrabble tiles spelling out 'GMP' on a wooden surface, with text overlay indicating 'Module 4 Understanding GMPs' on a green background.
Module 4: Understanding Good Manufacturing Practices
$89.95
One time

Learn what GMPs are and why they are significant. We'll explore the core components that form the backbone of GMP regulations and their significance in ensuring product quality, safety, and consistency.

✓ Learn about Good Manufacturing Practices
✓ Understand the 6 core elements of GMP
✓ Discuss continuous improvement

Testimonials

  • "As someone new to FDA regulations, this online training was exactly what I needed. The content was beginner-friendly, yet detailed enough to build a solid foundation. I now feel confident applying the concepts in my work"

    — Emily R., Regulatory Affairs Associate

  • "This training made FDA regulations much less intimidating! The course was easy to follow, with clear explanations and great examples. It’s perfect for anyone starting their career in a regulated industry."

    — Jason K., Quality Specialist

  • "I had no prior experience with FDA regulations, but this online training broke everything down step by step. It’s been a huge help as I prepare my company for FDA compliance. Highly recommend for beginners!"

    — Monica L., Small Business Owner, BioStart Solutions

A woman with long wavy brown hair smiling, sitting at a wooden table, holding a black tablet with a keyboard, in a room with a dark textured wall.

Why train with BatchWize ?

We translate complex concepts into practical working knowledge.

  1. Our training is supported by live quality support.

  2. Our courses are developed by industry veterans.

  3. Any company selling regulated products in the U.S. must follow FDA regulations to ensure product safety, prevents recalls, and avoid legal issues.

  4. We guide you through the essential elements for products such as foods, drugs, medical devices, and cosmetics.

New Training Modules - Coming Soon! -

New Training Modules - Coming Soon! -

Abstract geometric shapes with horizontal lime green and dark green bars, and a large lavender circle.

GMP Training

  • Module 5: GMPs & Enforcement Under The U.S. FDA

  • Module 6: GMPs for Medical Devices

  • Module 7: GMPs for Pharmaceutical Products

  • Module 8: GMPs for Biologics

  • Module 9: GMPs for Combination Products

  • Module 10: GMPs for Food & Beverage Products

  • Module 11: GMPs for Cosmetics

  • Module 12: Good Documentation Practices (GDP)

  • Module 13: Product Release

  • Module 14: The Big Picture

  • Module 15 : Corrective And Preventive Action (CAPA)

Practical training for FDA regulated products.

Our training is provided by industry experts with a working knowledge of FDA regulations, Product Approval, and FDA Inspections. BatchWize online training modules are perfect for beginner to intermediate levels. Take an online course by itself, or purchase a course bundle that includes our quality consulting services.

Meet our team

The BatchWize Team has expertise in quality, regulatory compliance, FDA submissions, engineering, validation, software, supplier management, project management, and more!

20+ years of practical experience

Medical Device, MedTech, Pharma, Biotech, Food, & Cosmetics

Portrait of a woman with long blond hair, wearing glasses, a blue collared shirt, and a dark blazer, smiling softly in front of a neutral background.
A woman with shoulder-length dark hair and glasses smiling outdoors, wearing a white shirt and a brown jacket.
A woman with shoulder-length light brown hair, wearing glasses, a black blazer, and a white blouse with black patterns, posing against a neutral background.

Our services

Training

Quality and regulatory training simplified! Online training modules + Custom Training + Onsite training

Quality Consulting

Quality and regulatory compliance consulting. We support pharma, device, MedTech, biologics, food, & cosmetics.

Product Release

We perform product release on behalf of manufacturing companies. Quality Record Review + Batch Review + DHR Review

  • "The beautiful thing about learning is no one can take it away from you"

    - B.B. King

  • "FDA Regulations are complex, your training shouldn't be."

    - BatchWize

  • "We needed simple GMP training that was easy to understand"

    - J. Scottman

  • "Quality is not an act, it is a habit."

    - Aristotle

  • "GMP training reduces regulatory risks & improves product quality."

    - BatchWize

Contact us

Email: Team@BatchWize.com
Hours: 8am - 4pm (CST)

Email us for questions on training or consulting services.