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Subscribe NewsletterDocument Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner
Product Id
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600265
Overview: Document control can be a time- and paper-consuming process.
Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system.
Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system.
Areas Covered in the Session:
- QSR and ISO 13485 requirements for document control
- Description of typical document control system in use
- Streamlined document control process
- Paper-free document review
- Immediate document distribution
- Paper-free document management system
Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Executive Management
- Document Control Management
- Document Control Clerks
- Consultants
- Quality system auditors