FDA: Mock and Pre-Approval Inspections (PAIs) - Part II

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 mock audit and during a Pre-Approval Inspection (PAI). For the latter, it will detail what will the FDA look for, among other related, in depth topics. The mock audits are useful tools, which provides you with identifying the non-compliance and gaps beforehand. Furthermore, it provides you with an understanding on where your issues lie, in order to address them proactively and effectively, before an actual inspection occurs by the FDA.

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 purposes of FDA’s Pre-Approval Inspections (PAIs), mock audits, and strategy used for the latter. It will list most DOs and Don’ts, to prepare you for the referred inspections and audits. In addition, you will learn each detail regarding each PAI objective, among other matters, so you have the opportunity to prepare adequately and effectively for this type of inspection, during pre and post submission stages of your drug product application, and be able to meet related project completion and approval timeframes to commercially be able to market your product.

Areas Covered in the Webinar:

The following topics will be addressed during this webinar:

• Purpose of Inspections and a Mock Audit
• Strategy for Mock Audits
• Dos and Don’t
• Background
• Pre-Approval Inspection Compliance Program 7346.832
• Findings and Deficiencies to Withhold Approval of an Application
• Domestic/International PAIs and Types of PAIs
• Priority Pre-Approval Inspections
• Overall Overview of the Three Primary Inspectional Objectives Regarding the PAI Program
• Priority Pre-Approval Inspection- FDA Recommendations and Reasons for Not Conducting this Type of PAI
• Reasons for Conducting a Discretionary Pre-Approval Inspection and Investigator Preparation before a PAI
• PAI-Type and Depth of Inspection/Audit Coverage, Objectives, and Techniques
• PAI Inspection Reporting
• PAI Inspection Reporting and Sample Collection or Sample Submission Requests
• FDA Laboratory Analysis of Samples
• Findings That May Result in an FDA-483
• Impact of a Negative PAI Report

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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