In this webinar attendees will learn the QSR and ISO 13485 requirements for document control and the ideas associated with the development and control of quality documentation. Also attendees will get knowledge on methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.
- QSR and ISO 13485 requirements for document control
- Description of typical document control system in use
- How to create uniform documentation that is easy to follow.
- Establish systems that will speed up review of new or revised documents.
- Streamlined document control process
- Eliminate common formatting problems that create confusion.
- Create more control over controlled documents in circulation.
- Ensure obsolete documents are removed from use.
- Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes
- Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate.
- Creating Action Plans, and verifying their effectiveness.
- Improving efficiencies over the QMS tasks
- Reducing the risks of manual error
- Ensuring compliance to 21 CFR Part 11 and immutable audit trail.
- Avoid observations, 483 letters and fines
- Taking the resource burden out of creating dashboards/ periodic reports
- Quality Assurance Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Documentation Departments
- Executive Management
- Everyone involved with FDA compliance