World Leader in Quality Life Sciences Training
Built by Experts. Backed by Experience. Designed for Life Sciences Community
Featured Courses
Live Expert-led training for pharmaceutical, medical device, biotechnology, clinical, validation, laboratory, and quality professionals.
Available for Instant Access
Selected courses available for immediate registration and streaming.
- EO Sterilization Validation and Revalidation Under ISO 11135: Practical Implementation and Lifecycle Considerations
- Acceptance Criteria for AI Validation: Determining What “Reliable” Actually Means in GxP Systems
- Aseptic Processing and Contamination Control Under EU GMP Annex 1: Practical Applications for Modern Sterile Operations
- Audit Trail Review by Exception: Reducing Reviewer Burden Without Weakening Detection
- AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend
- Root Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPA
- IQ, OQ & PQ: What Now Counts as Sufficient Validation Evidence
- ChatGPT-Assisted Technical Writing
- Digital Quality Metrics and AI/ML Analytics: Building a Continuous-Improvement Framework that Aligns with Regulatory Expectations
- AI Errors May Be Impossible to Eliminate - What That Means for Its Use in the FDA
- HPLC Analytical Method Development and Validation
- RCA & CAPA: What Inspectors look for Beyond a “Well-Documented” Investigation
- AI for CAPA and Investigations: Where It Helps and Where It Can Get You in Trouble
- Validating AI Use in Quality Systems: Practical CSV and CSA Approaches for FDA Inspection Readiness
- Environmental Monitoring Programs: Development, Implementation, and Evolving Expectations for Controlled Environments
- The First FDA Warning Letter on AI: What It Means for Your Quality System
- Inspection Readiness: Defending Your Use of AI to FDA and Auditors
- OOS Investigations: Decision-Making in Practice and FDA Expectations for 2026
- Validating Cloud & Digital GxP Systems Using a CSV/CSA Approach
- Risk-based Excel Spreadsheet Validation
- OOS and OOT Investigations Course - 9-hour training
- FDA Inspections After QMSR: What Replaces QSIT 2.0 - The New Inspection Reality
- Leveraging AI in Risk Assessment for Smarter Computer Systems Validation
- The FDA Medical Device File (DHF, DMR, DHR, Market Authorizations) and EU MDR Technical Documentation
Need customized training for a larger team?
TalkFDA courses can be customized and brought directly to your organization for larger teams, site-level programs, and department-specific training needs.
© All rights reserved