Pharma Compliance Webinars | Insights by WebinarWaves

Description

As globalization intensifies, U.S.-based manufacturers, distributors, and contract sponsors are increasingly relying on foreign suppliers to support operations. However, with this expansion comes significant regulatory risk, especially from the U.S. FDA. Foreign vendors are frequently cited for violations related to data integrity, inadequate quality systems, poor documentation practices, and failure to adhere to GMPs. These issues can trigger serious consequences, such as Form 483s, Warning Letters, Import Alerts, and refusal of product entry into the U.S. market.

This training is designed to equip both foreign vendors and their U.S. partners with practical tools to align with FDA compliance expectations. The session explores how FDA inspections are conducted overseas, what documents and practices are scrutinized most closely, and how to proactively identify and close compliance gaps. Attendees will walk away with an understanding of the most common FDA enforcement triggers and how to avoid them.

We will break down recent examples of FDA Import Alerts and 483s issued to foreign entities, providing insight into real-world inspection failures and their consequences. In addition, we’ll cover strategies for audit readiness, document control, CAPA effectiveness, quality agreements, and FDA’s expectations for remote evaluations and electronic records from foreign suppliers.

Whether you’re a Quality Director at a U.S. pharma company, a Regulatory Affairs professional managing a global supply chain, or a foreign vendor preparing for your first FDA inspection, this webinar delivers the insight you need to stay compliant—and stay in business.

Areas Covered:-

How the FDA inspects foreign facilities
What triggers Import Alerts and Form 483s
FDA expectations for documentation, data integrity, and QMS
Remote Record Reviews & e-record expectations
Critical components of an FDA-ready foreign supplier file
Case studies of Import Alerts and enforcement outcomes
CAPA and response expectations for foreign entities
How to align your practices with U.S. GMPs and GDPs
Proactive inspection readiness tips and tools
Role of U.S. importers and manufacturers in foreign vendor compliance.

Learning Objectives:-

Understand how FDA evaluates foreign suppliers and common enforcement triggers
Learn how to proactively prepare foreign vendors for inspection
Identify and correct high-risk compliance gaps in documentation and processes
Interpret recent FDA enforcement actions and apply lessons learned
Create a robust compliance file for each foreign vendor
Strengthen quality agreements and oversight practices for foreign entities.

Background:-

Global sourcing has become standard in regulated industries, but with that global reach comes increased FDA oversight. Foreign vendors supplying drug substances, APIs, excipients, medical devices, dietary supplements, or raw materials are subject to the same strict FDA requirements as domestic manufacturers. Unfortunately, many foreign vendors fall short of FDA expectations, resulting in Form 483 observations, Warning Letters, and even Import Alerts.

This training provides a proactive roadmap for foreign suppliers and the companies that rely on them to navigate FDA compliance successfully and stay off the radar for all the wrong reasons.

Why Should You Attend?

An FDA Import Alert or Form 483 is more than a temporary inconvenience—it can halt shipments, damage reputations, and cause severe disruption across your supply chain. This session is designed to help QA, Regulatory Affairs, and international business managers understand what the FDA expects from foreign vendors and how to prepare accordingly. Learn what documentation the FDA wants to see, how inspections are conducted abroad, and what common compliance pitfalls derail even well-meaning suppliers. Whether you’re a supplier or the manufacturer of record, this session is essential to protect your business.

Who Should Attend?