Topics
- Audit recommendations from the FDA Quality System guidance for cGMPs
- Regulatory requirements: FDA, EU, PIC/S
- Developing an SOP for audits of computer systems
- Effective development and use of audit checklists
- Conducting the audit: review procedures, walk through the computer system area
- Assigning responsibilities
- Auditing for data integrity
- Most critical questions to ask
- Documenting detailed audit findings
- Auditing in preparation for FDA`s ongoing Part 11 initiative
- Effective follow up
- The audit summary report
- Case study: going through a life audit
- Presenting evidence of the audit to the FDA
Who should Attend
QC and Lab managers, QA managers and personnel, Validation specialists, IT managers and system administrators, Training departments, Regulatory affairs, Consultants and Documentation department.
