Mastering FDA Inspection Readiness in 2025: Essential Trends and Strategies for Drug and Device Compliance
Exclusive Online Webinar | February 26, 2025 | 12 PM EST / 11 AM CST
Robbinsville, NJ — Compliance Architects® is excited to announce a must-attend online webinar, Mastering FDA Inspection Readiness: Key Trends and Strategies for Drug and Device Compliance in 2025, on February 26, 2025, at 12 PM EST / 11 AM CST.
This 90-minute expert-led webinar will provide critical insights and essential information for any company to prepare for and manage an FDA inspection successfully.
Delivered in an approachable panel discussion format, the session will cover a broad range of information necessary to ensure your company is always ready for the FDA to show up at your door and how to handle aggressive, determined investigators when they visit.
Why You Should Attend
Achieving successful FDA inspection outcomes is far more challenging than ever. Although the FDA has increasingly prioritized its inspection schedule, FDA inspections tend to be more focused, with better data and deeper inquiries into critical operations.
This exclusive webinar brings together a distinguished panel of a former FDA official and industry-leading quality and compliance experts to share first-hand knowledge, real-world case studies, and practical guidance for ensuring inspection readiness in 2025 and beyond.
This is a unique opportunity for professionals in the drug, biopharmaceutical, medical device, and research sectors, including those in compliance, regulatory affairs, quality assurance, clinical research organizations (CROs), Institutional Review Boards (IRBs), and more.
Gain expert insights and hear “war stories” that will empower your organization to proactively address inspection readiness, mitigate risks, and optimize FDA inspection outcomes.
What You’ll Learn:
- Emerging FDA inspection trends and regulatory priorities for 2025
- How to maintain constant inspection readiness: Best practices for ensuring your company or site is ready for the Investigator to walk in your door
- Proven strategies for successful FDA interactions and handling the Investigator during the inspection process
- Real-world case studies on overcoming inspection objections and challenging inspection situations
- Actionable steps to strengthen your organization’s subject matter experts to support the inspection process
Meet the Expert Panel
This power-packed session features renowned FDA and industry experts with decades of experience in compliance, regulatory affairs, and quality management:
Teresa Gorecki, Practice Director, Compliance Architects
Teresa is one of the industry’s definitive FDA inspection management experts. With over 30 years of quality assurance experience across medical device, pharmaceutical, and biopharma sectors and having directed dozens and dozens of inspections, Teresa brings deep, pragmatic expertise to one of the riskiest events your company can face.
Diluks De Silva, VP, Compliance Architects
A seasoned leader in quality operations for cell and gene therapies, radiopharmaceuticals, and biologics, Diluks has led successful FDA inspection outcomes worldwide.
Ricki Chase, Former FDA Director and Field Investigator
Providing the “lens” of the FDA with extensive FDA inspection experience and an industry consulting track record in driving quality system improvements, Ricki offers invaluable perspectives on always being ready for an FDA inspection and what to do about it when it occurs.
Gerard Appert – Chief Operating Officer, Compliance Architects
Compliance consulting operations expert with extensive experience in life sciences consulting and large-scale consulting operations delivery.
Secure Your Spot Today
This is an essential learning event for quality and operations professionals striving to master FDA inspection readiness in 2025. Don’t miss this opportunity to gain exclusive industry insights and expert strategies to help safeguard your organization’s business from the significant business and financial impacts of poor FDA inspection outcomes.
We suggest early registration since space for this event is limited. For more details and registration information, visit ComplianceArchitects.com.
About Compliance Architects
Compliance Architects is a trusted leader in FDA regulatory compliance, quality assurance, and risk management. Our team of seasoned industry experts and former FDA professionals provides both strategic solutions and operational execution support to help pharmaceutical, biotech, and medical device companies navigate complex compliance challenges and achieve sustainable regulatory success.