You will gain a thorough insight into the quality system requirements of the all new International ISO 13485:2016 Standard requirements for Medical Device single audit program.
This extremely informative webinar will truly build your knowledge. It will help you grow into fulfilling the quality and regulatory requirements as a professional working for medical device manufacturers of fully assembled devices and global suppliers manufacturing critical parts for the medical device industry. All key changes incorporated into this key international standard will be discussed to pave the path for implementation of the changes in your organization.
Why Should You Attend:
Employees of the medical device industry get audited to this important global standard and feel that they really don’t understand the auditor expectations for compliance to this standard.
You must attend this unique webinar presented by an expert trainer to erase any uncertainties in your quality, risk management, auditing and regulatory expectations and lay the foundation to make the switch from ISO 13485: 2003 to the brand new ISO 13485:2016 Medical Device Quality System Standard requirements.
Learning about the source and scope of the changes including the process of performing a gap assessment of your current quality system will help you to make a smooth seamless transition into the new requirements of this key international standard. This early understanding and implementation of the standard requirements will help you gain an edge in in the arena of competitive global medical device marketing.
Areas Covered in this Webinar:
• History of evolution of the standard elements and alignment of the standard with ISO 9001
• Comparison of the standard requirements to FDA 21 CFR 820 requirements
• Current vs Future expectations in the ISO 13485 world will be thoroughly examined to get you prepared
• A quick comparison of how the new standards of harmonization with FDA and GHTF Documents for alignment of the standard to cater to the Medical Device Single Audit Program MDSAP) will be discussed
• Deep dive into the audit elements that have changed and those that have been elevated for additional compliance
• Extension of the quality system requirements to the life cycle of the medical device
• Discussion of timeline for full implementation of ISO 13485: 2016 to initiate your planning for implementation
• Understand the key changes to ISO 13485: 2016 to facilitate the preparation for transition to the new ISO standard requirements
Who Will Benefit:
• Quality Assurance/ Auditing Personnel
• Design Engineers
• Research & Development Staff
• Quality Control Personnel
• Manufacturing Engineers
• Supplier Management Team
• Upper Management
Meena Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A. SC in Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar is now enrolled in MS Applied Clinical Research Program focusing on medical devices.
Meena is currently working as a Quality Associate for NAMSA under her LLC, MNQ Consulting Services. She worked as the Quality and Regulatory Manager for ProMed Pharma, Medical and combination device manufacturer in Minnesota, USA.
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