• Select your website

30/06/2011

Audit Reference

Regulatory Compliance support before FDA inspection

 

Industry: Biotechnology

Functional Environment: Mock audit, Supplier audit

Methodologies: Mock audit, training, 21 CFR part 210 & 211 & 820

Technical Environment: Quality System

 

Context & Objectives

Client required the consultant to support and coordinate regulatory compliance activities of their facility before an FDA inspection (21 CFR part 210 & 211/ 21 CFR PART 820).
 

 

Approach & Solution

• Mock Audits to FDA agreement on: Management, Documentation Management, Qualification-Maintenance, Validation, Deviation/CAPA, Complaints & Purchasing
• Supplier Audits: Chemical methods validation, Packaging I (syringes), Excipients & reagents, API
• GMP Training & Coaching: Basic cGMP,QMS, Warehouse-Clean Areas-Quality Control & FDA Inspections
  

 

Results & Added-Value

• FDA inspection passed successfully
• Completion of 7 Mock Audits to FDA agreement
• Completion of 7 supplier Audits
• Provision of GMP Training & Coaching (4 modules / 140 people)