Attend this course to prepare for and understand what will happen during a Drug Manufacturing Inspection for Surveillance Inspections. It will explain the FDA criteria to perform a For Cause Inspection.

Learning Objectives:-

This course will provide you with the system-wide controls the FDA requires from the regulated pharmaceutical industry as they will verify through Surveillance Inspections. It will also explain the purpose and strategy they use for these inspections. You will learn each detailed element they will cover for each system, during the referred inspection, and when do each type of surveillance inspection applies.

Areas Covered in the Webinar:-

The following topics will be addressed during this webinar:

• Background
• Objectives and Strategy Related to the Compliance Program 7356.002
• Strategy Related to the Compliance Program 7356.002
• Scheme of Systems for the Manufacture of Drugs/Drug Products
• Program Management
• Investigational Operations
• Analytical
• Typical Deficiencies Found as a Result of Systems Inspected

Why Should You Attend:-

Inspections by the FDA can be challenging and there are consequences if you do not meet the requirements. This is a detailed course designed to provide pharmaceutical professionals with the information they require, in order to prepare for and understand what will happen during a Drug Manufacturing Inspection (Compliance Program 7356.002) for Surveillance Inspections and it will explain the FDA criteria to perform a For Cause Inspection. For your awareness, it will detail what will the FDA look for during Surveillance Inspections, the purpose and types of Surveillance Inspections, and who selects which systems will be covered during an inspection. Furthermore, it will go into in-depth information on what will the FDA inspect for each system, and common deficiencies related to each of the systems.

Who Will Benefit:-

• Quality Auditors
• Compliance Officers
• Managers/Directors/Supervisors and Personnel Related to:
  • Regulatory Compliance
  • Regulatory Affairs
  • Quality Control
  • Quality Assurance
  • Research and Development
  • Project Management
  • Production/Manufacturing
  • Risk Management
  • Complaint Handling
  • Personnel who are new to the regulated industry
  • Document Control