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.
Learning Objectives:
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.
Areas Covered in the Session :
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
Who Should Attend:
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