Medical Devices, US FDA

Course Objective:

• Overview of the FDA and intention of the 21 CFR Part 820 Quality System Regulation (QSR)
• To understand the up-to-date requirements of 21 CFR Part 820 QSR and other Parts such as Part 11, Part 803 and Part 821
• Working knowledge in application of the requirements
• Preparation for FDA

Course Objective:

• General requirements for Process Validation
• The linkage of the Process Validation with the standards and regulatory requirements
• Step-by-step on performing the Process Validation
• Hands on experience to develop Process Validation documentation

Course Objective:

• General requirements for Software Validation
• The linkage of the Software Validation with the standards and regulatory requirements
• Step-by-step on performing the Software Validation.