FDA Validation Inspections and Latest Trends – FDA Validation Inspections and Latest Trends – The presentation will discuss FDA audit observations relating to validation. In particular, the presentation will examine why validation is consistently one of the most common observations reported in FDA audits and which types of validations generate warning letters. In particular, the presentation will focus on Computer System Validation, Equipment Validation and Cleaning Validation.
Computer System Remediation & Validation for Regulatory Inspection – A Case Study – This presentation will outline a computer software validation compliance program. In particular, the presentation will demonstrate methods to generate validation documentation, and provide validation solutions for commonly used software like MS Access and MS Excel. The presentation will also include a validation case study review.