Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements
Duration : 60 Minutes
Jeff Kasoff,
Jeff Kasoff, RAC, CMQ/OE, Lean Black Belt, has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff unique Read more
This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.
Course Objective:
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.
Course Outline:
• 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.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that are interested in spending less time on document implementation. The employees who will benefit include:
• Executive Management
• Document Control Management
• Document Control Clerks
• Consultants
• Quality system auditors
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
