WHAT FDA EXPECTS IN DATA INTEGRITY COMPLIANCE
Data Integrity Training Slide Deck (FDA-Focused, GMP-Compliant)
Price: $69 USD
This downloadable presentation is a professional, ready-to-use training tool covering current FDA expectations for data integrity compliance—with real-world enforcement examples, ALCOA+ principles, and remediation strategies.
Designed by a former FDA Investigator, this resource is ideal for pharmaceutical and biotech companies preparing for inspections, remediating Warning Letter findings, or training QA and laboratory staff on data governance best practices.
This training covers:
- FDA, EMA, and WHO expectations for data integrity
- ALCOA+ applied to paper, electronic, and hybrid systems
- Data lifecycle risks: creation, modification, review, archival
- Audit trail failures, shared login issues, Excel misuse
- Metadata compliance and time synchronization gaps
- 2023–2025 FDA Warning Letter trends
- Real enforcement case: MARCS-CMS 699183 (Jiangsu, China)
- FDA’s remediation demands: third-party audits, CAPAs, and Chief Integrity Officer roles
Ideal for:
- Quality Assurance and Quality Control teams
- Laboratory managers and analysts
- IT/CSV/computerized systems teams
- GMP trainers and consultants
- Regulatory affairs professionals
Format: PDF (20 slides, watermark-free, presentation-ready)
Bonus: Pairs well with the optional quiz and certificate add-on (available separately).
Contact: devaughn@fdaid.org for site licenses, customization, or live Zoom training.
A professional, FDA-aligned slide deck covering the fundamentals of data integrity compliance. Includes real-world enforcement examples, audit trail failures, and FDA remediation expectations. Ideal for training QA, lab, and IT teams.