Preapproval Inspection and Submission to the FDA
🎤 John E. Lincoln | 📅 March 19, 2025 | 🕒 11 AM Eastern Time US
Is Your FDA Submission Ready for Approval?
🚀 Do you fully understand FDA’s preapproval inspection expectations? 🚀 Is your facility, personnel, and documentation aligned with FDA compliance? 🚀 Want expert strategies to minimize risks and accelerate approval? This webinar is critical for professionals involved in FDA submissions, compliance, and regulatory approval, including: 👨💻 Senior Management in Pharma & Medical Device Companies – Oversee regulatory readiness for FDA approval. 🏭 Quality Assurance (QA) & Regulatory Affairs (RA) Teams – Strengthen cGMP compliance strategies. 🛠 R&D Scientists & Engineers – Align product development with regulatory expectations. 📊 Production & Operations Managers – Ensure manufacturing practices meet FDA approval standards. 💡 Compliance & Validation Experts – Prepare teams for FDA on-site evaluations & establishment file reviews. 📈 Marketing & Business Development Teams – Accelerate product launches with faster FDA approval. Applicable industries: Pharmaceuticals | Medical Devices | Biotech | Clinical Research | Regulatory Compliance |
Securing FDA approval for NDA, ANDA, or PMA submissions is more than just a regulatory step—it’s a make-or-break moment for pharmaceutical and medical device companies. Non-compliance during a preapproval inspection can lead to application delays, warning letters, or outright denials. Understanding 21 CFR 210/211 (for pharmaceuticals) and 21 CFR 820 (for medical devices) is essential for ensuring compliance in manufacturing, processing, packaging, and testing. This webinar provides an in-depth guide to FDA’s preapproval inspection process, covering common compliance pitfalls, documentation best practices, and risk-based strategies to pass inspections with confidence. Join John E. Lincoln, a regulatory expert with 36+ years of experience in FDA-regulated industries, as he walks you through the entire preapproval inspection process—so you can secure FDA approval faster and with fewer obstacles.
Key Topics Covered:
📌 Understanding FDA Preapproval Inspections – Regulatory expectations for NDA, ANDA, and PMA submissions
📌 21 CFR 210/211 & 21 CFR 820 Compliance – Mastering cGMPs for pharmaceuticals and medical devices
📌 Critical Inspection Focus Areas – Personnel, facilities, equipment, validation, and documentation
📌 Risk-Based Compliance Strategies – Facility, product, and process risk assessments
📌 Handling FDA Audits & Post-Market Surveillance – Preparing for inspection triggers & establishment file reviews
📌 Strengthening Pharmacovigilance Programs – The role of drug safety in preapproval compliance
📌 Common FDA Pitfalls & Enforcement Trends – Lessons from 483 observations & warning letters
