July - Warning Letter Wednesday (WLW)
Readiness for Unannounced FDA Inspections: What You Need to Know
In May of 2025, the FDA announced it would start increasing unannounced inspections at foreign pharmaceutical facilities. For a long time, many of these sites were given advance notice, unlike U.S. manufacturers who often have to be ready at any moment. That’s starting to shift. If your team isn’t prepared for a surprise visit, the consequences can be serious. Form 483s are often the result of unclear roles during inspections, inconsistent SOPs, or documentation that’s incomplete or hard to find.
Join us for a high-impact webinar designed to keep your organization inspection-ready, anytime. We’ll break down the top triggers for unannounced FDA inspections, reveal what investigators focus on in the crucial first 30 minutes, and share how to structure your team and documentation for a confident, coordinated response. Whether you work in QA, compliance, or operations, you'll walk away with actionable strategies, real-world case examples, and proven best practices to minimize risk and strengthen your inspection readiness.
You’ll also get a hands-on look at WLW’s AI-powered tools, built to streamline compliance workflows, flag potential gaps, and generate insights from thousands of inspection records. Whether you're new to the regulatory world or a seasoned professional, WLW offers a collaborative space to stay sharp and stay compliant. Bring your team and your questions!
Guest Speakers:
Daniel Barreto, President and Owner of PharmQ Global Consulting, LLC. Established in 2020, PharmQ specializes in providing strategic, operational, and tactical consulting services to clients in the pharmaceutical industry.
Martin Orcoyen, President of ISPE Argentina, has over 20 years of experience in pharmaceutical quality and regulatory consulting. He currently serves as COO Sudamérica at QUALIPHARMA and sits on the board of EntrePuentes.
Dr. Ligia Zubik, Director of Quality at Global Key Solutions, has over 20 years of experience leading regulatory compliance and inspection readiness at major pharmaceutical companies.
Kasia Grzelecka has over 15 years of experience driving procurement, supply chain, and digital operations in the biopharma industry. She has led global sourcing strategies, improved regulatory timelines, and implemented innovative technologies to enhance operational efficiency.
Whether you're new to the regulatory world or a seasoned professional, WLW offers a collaborative space to stay sharp and stay compliant. Bring your team and your questions!
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