Build confidence and reduce risks with our expert-led FDA training.
When it comes to FDA inspections, preparation is crucial. If you are not ever ready for an FDA inspection, your company’s business can be put at significant risk. Compliance Architects® offers the most comprehensive inspection readiness training anywhere to ensure your team is ready to handle even the most rigorous inspection with confidence and certainty.
Going well beyond just the regulations, our 90-minute online inspection readiness training program, Survive and Thrive During FDA Inspections, provides you with a comprehensive background in FDA’s inspection authority, along with approaches to ensure you are “ever ready” for an inspection, including a detailed review of the activities needed to manage the inspection effectively and efficiently. Whether you’re facing an initial FDA inspection or are a veteran of inspection management, our 90-minute inspection readiness training has something for everyone who is looking to reduce their risk from aggressive FDA enforcement!
An FDA inspection is potentially one of the most significant risk situations an FDA-regulated company can experience. The costs to a company from a poor FDA inspection can be in the millions – hundreds of millions – or in extreme cases, billions – of dollars. You risk reputational loss and failure to obtain new product approvals. Many high-stakes litigations don’t have the sort of potential business risks that an FDA inspection can have. And shockingly, most companies are woefully prepared, and never really train their people on the why, how, and what of an FDA inspection.
Taught by two of the FDA-regulated industry’s leading experts in inspection management, Teresa Gorecki and Jack Garvey, Survive and Thrive During FDA Inspections brings you time-tested and industry-leading concepts that only a few of the best companies in the world may know. Teresa and Jack provide practical advice to help you build trust with the regulators during an FDA inspection – one of the most critical things that you need to achieve to be successful.
Performing poorly during an FDA inspection can result in costly regulatory actions, from FDA 483 observations to warning letters, recalls, or worse! This is why comprehensive, well-structured inspection preparation training is essential for your company and your staff. Compliance Architects’ inspection readiness training program not only covers the technical and operational aspects of inspection readiness but also helps your employees build confidence through inspection stories that are related during the training. You can have confidence that this training will provide you and your with the best information available to be, ready for an FDA inspection – short of Jack and Teresa being onsite with you!
Survive and Thrive During FDA Inspections covers every critical aspect of FDA inspection readiness:
When preparing for an FDA inspection, trust Compliance Architects to be your partner in success. Our FREE inspection readiness training, Survive and Thrive During FDA Inspections, is our way of introducing you to our firm – the leading FDA quality and compliance consulting firm. This training will help you understand the most important concepts necessary for a good inspection outcome. But, we know good inspections don’t always occur. If your inspection was difficult – or you’ve received an FDA 483, call us! We can immediately help you to address the FDA’s concerns, reducing further risk and possibly the risk of further enforcement action.
Equip your organization with the skills and confidence to excel under scrutiny. Reach out to Compliance Architects today to learn how we can help your team master inspection readiness and build a robust culture of compliance.
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