The FDA requires all stakeholders supporting FDA cGMP activities to have adequate training and experience to perform their assigned functions. cGMP advances an individual contributor’s working knowledge, skills, and effectiveness. This helps to proactively reduce regulatory risks; and facilitates FDA compliance, with final aim of patient safety.
It’s worth spending time during this pandemic on virtual training to learn and upgrade knowledge on various topics of pharmaceutical manufacturing and quality systems.
The course provides a breakdown of the current Good Manufacturing practice requirements from the FDA and includes subpart detail. Additionally, this training gives a better understanding of the subparts located within 21 CFR Parts 210 & 211. This training session will also throw light on controls needed to combat Corona Virus by maintaining good manufacturing and quality systems.
This training is specially designed for the Pharma professionals working in manufacturing, Quality, Regulatory and Distribution functions responsible for delivering quality Product.
Areas Covered in the Session :
- Define key terms for cGMP
- Recognize the role of the FDA
- Describe the different types of inspections
- Explain the Quality System
- Relate 21 CFR to your roles and responsibilities
You will also learn about:
- Quality systems
- Laboratory control system
- Production system
- Packaging and Labeling control system
- Material system
- Facility and Equipment system
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Production Departments
- Warehouse Professionals