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)
