Drug Manufacturing Inspection Part III

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 in each of the systems.

Note: This webinar requires a pre-requisite webinar titled, "FDA Inspections: Understanding the Core Elements – Part I"

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 apply.

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

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
Instructor Profile:



Vanessa Lopez
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services

Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.

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