$1,200

FDA Data Integrity Direct-To-Site Training: What You Need To Know To Avoid A Disaster

Buy this

FDA Data Integrity Direct-To-Site Training: What You Need To Know To Avoid A Disaster

$1,200

Data integrity violations remain one of the top reasons companies receive FDA Warning Letters.
This live 30-45 minute mini-workshop, taught by a former FDA Investigator, breaks down the essentials of data integrity and the most common problems FDA inspectors are still finding. This training will be given live via Zoom to your company with unlimited attendees and certificates (upon completion of knowledge assessment)! You set the data/time! Contact: DeVaughn Edwards at: devaughn@fdaid.org; 732-895-7831 (direct and Whatsapp); devaughn@gmail.com

You'll walk away with real-world examples, practical insights, and the clarity you need to avoid inspection-day disasters.


💡 What You'll Learn:

  • The basics of data integrity and how ALCOA+ applies to your operations
  • Why over 60% of FDA Warning Letters cite data integrity failures
  • The top deficiencies: missing audit trails, backdated entries, uncontrolled access, and falsified data
  • What FDA investigators are trained to look for—and how to prepare your systems and records accordingly

📁 Included with Your Registration:

  • ✅ Live 30-45 minute Zoom sessionAvailable: ✅ Printable slide deck (+ $10) - sold separately. Forward a request to devaughn@fdaid.org and a PayPal invoice will be sent to you via email.
Buy this

Learn what the FDA expects—and what companies keep getting wrong. This 30-minute mini-workshop covers the basics of data integrity, the ALCOA+ principles, and the most common violations seen in FDA warning letters. Taught by a former FDA Investigator, this session includes real inspection insights

Product Type
Live Zoom Training
Topic
Data Integrity, FDA Compliance, ALCOA+, GMP Systems
Industry
Pharmaceuticals, Biotech, Medical Devices, CDMOs
Use Case
Team Training, FDA Audit Prep, Data Governance, Remediation
Created By
Former FDA Investigator
Delivery Format
Live Zoom Session (45–60 minutes), Scheduled Per Site’s Availability
Includes
Presentation, Quiz, Certificates of Completion
Level
Intermediate to Advanced
Add-Ons Available
Follow-up Consulting (separate charge; contact devaughn@gmail.com)
Size
2.83 MB
Resolution
1728 x 2304 px