Project Management for Computer Systems Validation
Cleaning Validations Using Extraction Techniques
21 CFR 11 Compliance for Excel Spreadsheets
Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
Acceptance Activities in FDA QSR
Marketing FDA Regulated Products Through Social Media
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
How to manage virtual employees and achieve real results… any time… any place
How to Manage a Product Medical Device Recall Efficiently and Effectively
Construct and manage the technical file and design dossier
Creating Value: Employee Engagement at Work
The Hitchhiker’s guide to 483s and warning letters