While many organizations have the right intent of stepping up to conform to the latest revision of ISO 13485, many struggle on the journey. Some unsure of where and how to start, some start their journey but falter along the way, and yet others attempt at sporadic patchwork of their QMS and SOPs potentially resulting in gaps exposing the organization to the risk of non-compliance and / or non-conformance.
Rai Chowdhary has been guiding many organizations on how to do this transition in a smoother and effective manner while ensuring compliance with the requirements of 21 CFR 820, and ISO 13485. This seminar discusses the essential steps, shows you the road map, and guides how to create your own. The approach is based on his upcoming book “Do-Magic at Work” that presents a system and framework for organizations to succeed in their initiatives. Do not miss this opportunity to learn this wonderful approach.
- Get an early-and-running start
- Ability to assign responsibilities easily
- Establish key milestones and deliverables along the journey (for ISO 13485, and 21 CFR 820)
- Check your progress on the roadmap
- Having a successful transition
- Quality Departments (Managers, Auditors, Engineers, Associates)
- Regulatory Departments
- Compliance Departments
- Program Managers
- Operations Departments
- Site Managers
- Corporate Quality Departments
- Production Departments
- New Quality Assurance Managers
- ISO 13485 Implementation Team Members
- Management Representatives
- Project and Program Management Teams
- Safety and Quality Auditors
FDB2011