FDA Inspections: Understanding the Core Elements – Part I

Why Should You Attend:

This is a detailed course designed to provide pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. The elements of an FDA inspection are established by the agency and recognized by the regulated industry. The unsaid part is that pharmaceutical and medical devices companies reiterate the inspection process, but fail to maintain controls, track responsibilities and monitor their regulated products and activities, adequately. Corrective actions implemented may not be effective on account of inability to identify the “true” root cause and appropriate and timely implementation of corrective action plans, effectiveness checks and closures.

The best practices to manage the inspection and establish, monitor and maintain controls of your regulated product and activities are fundamental. Companies need to bear in mind that nothing should fall through the cracks and must ensure that lessons learned are remembered to avoid any re-occurrences by implementing, monitoring and maintaining an effective cGMP/Quality System as notice for the next FDA inspection might be on its way.

This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

1. "Mock and Pre-Approval Inspections (PAI)"
2. "Drug Manufacturing Inspections"

Learning Objectives:

• This course is designed to meet the objectives of preparing for and managing an FDA Inspection. It will provide you with the actual flow and processes of company activities before, during, and after an FDA inspection.
• In addition, it will furnish you with roles and responsibilities related to an inspection, the consequences resulting from non-compliance to FDA requirements and the impact this has on regulated products, competitiveness in the market, on revenue, distribution, reliability status, and even partnerships with suppliers, among others.
• Furthermore, it will delineate the challenges you will encounter regarding an FDA inspection, in preparing and managing the inspection, and the benefits of successful results from these types of inspections.

Areas Covered in the Webinar:

The webinar will furnish details on the following topics:

• Purpose of FDA Inspections
• Some of the Regulations That Apply to Pharmaceuticals of Human Drugs
• How Does FDA Decide Who to Inspect?
• Inspection Frequency, Relationship to PMAs/NDAs/BLAs and Reference to the Inspection Model
• About NIPP
• EU and FDA Mutual Recognition Program/ New Inspection Protocol Project (NIPP)/ Risk Factors
• FDA Enforcements
• Example of DOJ Pharma/Device Settlements
• How Does “QSIT” Relate to the Pharmaceutical Industry
• Preparation for an FDA Inspection
• Inspection Process: What to Expect From FDA’s Arrival Up to Their Exit
• Timelines to Respond to 483s and Warning Letters and Sequence of Response
• Inspection Observations/Findings-Trends
• Examples of Inspectional Findings on Warning Letters
• Challenges
• Conclusions

Who Will Benefit:

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

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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