Strategy and Roadmap for Transition to ISO 13485:2016

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.

Areas Covered in the Session :

• 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

Who Should Attend:

• 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

Course Director: RAI CHOWDHARY

Rai Chowdhary brings over 30 years of business and technical expertise from diverse industries to bear during his workshops. He has implemented Risk Management in several organizations, and coached thousands of participants in the approach. He has worked with / for world leaders such as Applied Materials, Dell, DuPont, Frito-Lay, Tokyo Electron, Samsung, Intermedics Orthopedics / Sulzermedica, Abbott Spine, Amedica, Edwards Life Sciences, Evenflo, Reckitt Benckiser, Ultradent, Siemens, GE, Philips, and more. Rai holds certifications from ASQ as: Quality Auditor, Quality Engineer, Quality Manager / Operations Excellence, and Six Sigma. He has conducted several workshops (including Lead Auditor training) on a vast range of topics such as: ISO 9001, 13485, 14971, IEC 62366, AS 9100, 21 CFR 820, MDDEV, Risk Management, Lean, Six Sigma, etc. He is an award winning presenter, and top rated workshop leader. His book on The Ten Mistakes of Risk Management was first published in 2007; an updated version is expected soon.