What will FDA expect and request from your firm during Design Control portions of Inspections?
Category: All FDA Regulated Industry , FDA Audit and Inspection , Quality and Safety , Audit & Inspection-Role , All FDA Reg. based Audit , Life Sciences

Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation
Category: Medical Devices , FDA Audit and Inspection , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , R & D , Research & Development , Device R & D , Life Sciences

How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters
Category: Medical Devices , Audits & Inspections , Audit & Inspection-Role , Medical Device Inspection , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences , Documentation and Data Management

Understanding the new International and FDA accepted Software Development Standard IEC 62304
Category: Medical Devices , All FDA Regulated Industry , Life Sciences , Documentation and Data Management

'Performing effective supplier audits: a coming FDA compliance focus'
Category: All FDA Regulated Industry , Quality Management , FDA Audit and Inspection , Quality and Safety , Audit & Inspection-Role , All FDA Reg. based Audit , Life Sciences

Using the FDA guidance General Principles of Software Validation to strengthen your firm's software FDA compliance
Category: Medical Devices , All FDA Regulated Industry , FDA Validation , Documentation and IT , Life Sciences

How to perform effective supplier audits, and avoid FDA 483
Category: All FDA Regulated Industry , FDA Audit and Inspection , Quality and Safety , Audit & Inspection-Role , All FDA Reg. based Audit , Life Sciences

What are best practices for creating a Risk Management File?
Category: Drugs and Chemicals (Pharma) , Medical Devices , Risk Management , Quality Management , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences , Documentation and Data Management