RCA for GMP Investigations FDB3751

The Leader in Quality Life Science Training INSTANT STREAMING COURSE Root Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPA Examine how repeatable failure investigation methods, structured root cause analysis, and closed-loop CAPA support lasting corrective actions and stronger GMP quality systems. ♟ Faculty John E. Lincoln ▶ Format Ready-to-Stream Course Details […]

FDA EXPECTATIONS FOR 505(B)(2) REGULATORY PATHWAY FOR NEW DRUGS

The Leader in Quality Life Science Training READY-TO-STREAM COURSE FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs A practical review of 505(b)(2) application requirements, reliance strategies, CMC expectations, product categories, and FDA approval pathway considerations. Kelly Thomas 90 Minutes Instant Streaming Available Assessment & Certification 30-Day Continued Learning REGISTER NOW Included with TalkFDA Subscription. […]

The First FDA Warning Letter on AI: What It Means for Your Quality System

Live Webinars Seminars Packs READY-TO-STREAM COURSE The First FDA Warning Letter on AI What It Means for Your Quality System June 05, 2026 11 AM Eastern Time US 3 PM GMT 60 Minutes Streaming Available 90 Minutes Certificate of Completion REGISTER NOW Designed for professionals managing digital quality systems, AI-enabled workflows, computerized processes, compliance oversight, […]

AI for CAPA and Investigations

Live Webinars Seminars Packs READY-TO-STREAM COURSE AI for CAPA and Investigations Where It Helps and Where It Can Get You in Trouble May 27, 2026 11 AM Eastern Time US 3 PM GMT 60 Minutes Streaming Available 60 Minutes Certificate of Completion REGISTER NOW Designed for professionals responsible for investigations, root cause evaluation, CAPA effectiveness, […]

Environmental Monitoring Programs: Development, Implementation, and Evolving FDA Expectations for Controlled Environments

Live Webinars Seminars Packs READY-TO-STREAM COURSE Environmental Monitoring Programs Development, Implementation, and Evolving FDA Expectations for Controlled Environments May 26, 2026 11 AM Eastern Time US 3 PM GMT 90 Minutes Streaming Available 90 Minutes Certificate of Completion REGISTER NOW When reviewing your monitoring strategy, the question is whether sampling locations, frequencies, and limits still […]

Leveraging AI in Risk Assessment for Smarter Computer Systems Validation

INSTANT WEBINAR STREAMING Leveraging AI in Risk Assessment for Smarter Computer Systems Validation Risk models often rely on static scoring that no longer reflects how interconnected GxP systems behave across validation, release, and ongoing operation decisions. This session establishes a structured method to incorporate AI-based signals into validation risk assessments, strengthening evidence trails and maintaining consistent […]

Good Clinical Practices (GCP) Audit and Inspection Readiness

WEBINAR INSTANT STREAMING ACCESS Good Clinical Practices (GCP) Audit and Inspection Readiness February 06, 2026 11 AM Eastern Time US 4 PM GMT 90 Minutes Streaming Available 60 Minutes Certificate of Completion REGISTRATION OPTIONS This course sharpens GCP audit and inspection readiness by turning quality systems, documentation, and training into defensible proof of compliance that […]