Navigating FDA Inspections Successfully

Overview:
FDA inspections are an unavoidable part of operating in regulated life science industries. This webinar helps you take the guesswork out of inspections by breaking down the most frequent issues flagged by the FDA and providing proven strategies to prevent them. Learn how to build a culture of compliance, prepare your team, and minimize your organization’s risk exposure.

Webinar Agenda:

• A step-by-step overview of the FDA inspection process
• FDA 483 Observations and Warning Letters: what they mean and how they escalate
• The most common findings — from documentation gaps to inadequate training
• Real-world examples of inspection failures and lessons learned
• Strategies for developing strong CAPA processes and thorough investigations
• Proactive approaches to facility, equipment, and record-keeping compliance
• Creating an inspection readiness plan to stay audit-ready at all times

Why Attend?

• Gain a deep understanding of what FDA inspectors look for
• Learn to anticipate and address the most common deficiencies
• Reduce the likelihood of receiving FDA 483s or warning letters
• Equip your team with tools to maintain a state of constant readiness
• Protect your brand’s reputation and ensure operational continuity

Why This Training Is Important:

When it comes to FDA inspections, prevention is far more effective (and less costly) than correction. Being prepared not only protects your company from fines and disruptions but also fosters trust with regulators and clients. This session will empower you to move beyond reactive fixes and establish a proactive compliance framework.

Who Should Attend?

• Quality and Compliance Managers
• Regulatory Affairs Specialists
• Operations and Manufacturing Leaders
• Internal Auditors and QA Teams
• Training and Documentation Staff
• Facility and Equipment Managers
• Consultants and Advisors in regulated industries