Regulatory Auditing

Audit Areas Management Responsibility Auditing (internal and external) Design Control Document Control Purchasing Control Identification and Traceability

Audit Areas Production and Process Control Production control Inspection, measuring and test equipment Process validation Acceptance Activities Receiving In process Finished goods

Audit Areas Non Conforming Product Options Corrective and Preventive Actions Labeling and packaging control Handling, storage and distribution Records Device Master Record Complaint files

Audit Areas Servicing Customer Service and satisfaction Training Records

Process of Auditing Meeting to review process and timing Tour of company Ask for records Review records Ask for interviewees if necessary Write preliminary report Review prelim report w/mgmt

Types of Equipment Manufacturing Formulation Filling Labeling Packaging In Process testing Weight: balances pH

Types of Equipment Quality Control pH Chemistry testing Inspection: visual, weight, micro, In process testing

Personal Protection Equipment Lab coats Safety glasses Bonnets Booties Full suits

Which ones are involved in label design and control? Manufacturing Quality Assurance Quality Control Chemistry Microbiology Inspection Regulatory Audits Clinical Trials FDA filings Materials Management Receiving Distribution Inventory Control Human Resources Finance Sales and Marketing Management Research and Development