Quality Assurance & GMP
About This Course
Build a rock-solid quality assurance system that keeps your manufacturing operations compliant and your products safe. This course teaches you the practical side of GMP—not just what the regulations say, but how to actually implement them in your facility. You'll learn how to create documentation systems that work, conduct validations that pass inspections, and maintain quality standards day after day. We show you real-world examples of what works and what doesn't, so you can avoid the costly mistakes that shut down production lines. Whether you're new to QA or looking to strengthen your existing program, this course gives you the foundation to build quality into every process. You'll understand how to train your team, manage documentation, handle deviations, and prepare for inspections with confidence.
What's Included
Course Format
Self-paced, on-demand learning with lifetime access. Complete at your own speed with no deadlines.
Key Topics Covered
What You'll Learn
- Understand GMP regulations and requirements
- Establish quality assurance systems
- Implement documentation and record-keeping practices
- Conduct validation and qualification activities
- Maintain GMP compliance
Course Outcomes
By the end of this course, you will be able to:
- Establish effective quality assurance systems
- Implement GMP documentation practices
- Conduct validation and qualification activities
- Maintain GMP compliance
- Prepare for regulatory inspections
Who Should Take This Course
- Quality assurance professionals
- Manufacturing personnel
- Regulatory affairs specialists
- Quality control analysts
- Anyone working in GMP environments
Course Content
Module 1: GMP Fundamentals
- GMP regulations overview
- Quality systems framework
- Personnel and training requirements
Module 2: Documentation Systems
- SOP development and management
- Batch records and documentation
- Change control procedures
- Document retention
Module 3: Validation & Qualification
- Equipment qualification
- Process validation
- Cleaning validation
- Computer system validation
Module 4: Quality Control
- Laboratory controls
- Testing and release procedures
- Out-of-specification investigations
- Stability testing
This course is delivered through Thinkific. You'll receive access instructions after enrollment.