Medical Devices, Regulatory Requirement

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:

• Understanding the GDPMD requirements
• Awareness on the key elements to ensure medical device quality and safety along the supply chain.

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:

• Understanding of the GDPMD requirements
• Understanding the audit principles
• Plan, conduct, report and close out an internal audit

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.

Course Objective:

• Understanding what is medical devices
• Understanding of the Malaysian Medical Devices Law