Creating Successful Device History Record and keep FDA happy in the process
Overview:
Many companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue.
Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production records regulations; with an emphasis on just what is it that FDA is looking for. Emphasis will be placed on the Quality System Inspection Technique (QSIT) which FDA uses as an inspection tool.
Learning Objectives:
- Learn what FDA expects and will request from you during your DHR review.
- How QSIT inspections related to record keeping is performed by FDA.
- How Change can affect DHRs.
- Learn what constitutes a good DHR procedure.
- Learn how risk management fits into DHR compliance.
- Learn how to better audit quality record systems.
Areas Covered in the Session:
- Introduction
- Guidance documents/ QS regulation
- Major FDA 483 points
- Trends in FDA warning letters
- Determining best practice for the DHR audit
- Be prepared by knowing how to conduct a MORE thorough record audit
- FDA 483 point issuance prevention
Who Will Benefit:
- Senior executives of pharmaceutical and device firms
- Quality Unit Vice Presidents
- Directors and Managers
- Vice presidents
- Directors and Managers of operations
- Quality Engineers and field Auditors
- Regulatory and Compliance Management
- Consultants