Document control can be a time- and paper-consuming process. To your start-up, time is a valuable commodity. So is money.
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. Your start-up 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. And the best thing... it utilizes software you already have.
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
- Q/A Session with the Expert to ask your question
- PDF print only copy of PowerPoint slides
- Certificate of attendance
Director of Quality ,
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
This webinar will provide valuable assistance to all resource-challenged FDA-regulated companies, since Document Control is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields no matter how small how you are!
The employees who will benefit include:
- Executive Management
- Document Control Management
- Document Control Clerks
- Quality system auditors