The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
WebcastFaculty
OVERVIEW
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization is organized by Compliance4All and will be held on Feb 16, 2018.
Who Will Benefit:
• Medical Devices Quality Personal (QA and QC)
• Laboratory Managers
• R&D Researchers of Medical Devices and Combined Products
• Quality Control Staff
• Regulatory Affairs (RA) Staff.
Overview:
This ISO 13485:2016 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices.
Why should you Attend:
For people in the medical devices industry which either develops or planning to market medical devices to USA and Europe and plan to implant a QMS that complies with both regulatory authorities and ask themselves how to do it correct and efficiently.
Areas Covered in the Session:
• Introduction
• Brief review of regulations and standard: status and history
• ISO 13485:2016 short review
? Principals
? Quality management system
? Management responsibility
? Resource management
? Product realization
? Measurement, analysis and improvement
• FDA QSR (21CFR820) short review
? Quality System Requirements
? Design Controls
? Document Controls
? Purchasing Controls
? Identification and Traceability
? Production and Process Controls
? Acceptance activities
? Nonconforming Product
? Corrective and Preventive Action
? Labeling and Packaging Control
? Handling, Storage, Distribution, and Installation
? Records
? Servicing
? Statistical Techniques
• Comparison between both QMS
? Common features
? Variances between both
• Terms/ vocabulary
? Comparison between terms
• Summary
Speaker Profile: Eyal Lerner is owner of ELC Consulting Services which offers the pharmaceutical and medical devices industries support in all quality related issues: Preparation for inspections, CAPA and RCA, quality manual QSM, self-inspection, compliance gap analysis, 3rd party audits, Management Review, GMP, GLP,MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 and Validation.
Event Fee: One Dial-in One Attendee Price: US$150.00
Additional details will be posted as soon as they are available.
Who Will Benefit:
• Medical Devices Quality Personal (QA and QC)
• Laboratory Managers
• R&D Researchers of Medical Devices and Combined Products
• Quality Control Staff
• Regulatory Affairs (RA) Staff.
Overview:
This ISO 13485:2016 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices.
Why should you Attend:
For people in the medical devices industry which either develops or planning to market medical devices to USA and Europe and plan to implant a QMS that complies with both regulatory authorities and ask themselves how to do it correct and efficiently.
Areas Covered in the Session:
• Introduction
• Brief review of regulations and standard: status and history
• ISO 13485:2016 short review
? Principals
? Quality management system
? Management responsibility
? Resource management
? Product realization
? Measurement, analysis and improvement
• FDA QSR (21CFR820) short review
? Quality System Requirements
? Design Controls
? Document Controls
? Purchasing Controls
? Identification and Traceability
? Production and Process Controls
? Acceptance activities
? Nonconforming Product
? Corrective and Preventive Action
? Labeling and Packaging Control
? Handling, Storage, Distribution, and Installation
? Records
? Servicing
? Statistical Techniques
• Comparison between both QMS
? Common features
? Variances between both
• Terms/ vocabulary
? Comparison between terms
• Summary
Speaker Profile: Eyal Lerner is owner of ELC Consulting Services which offers the pharmaceutical and medical devices industries support in all quality related issues: Preparation for inspections, CAPA and RCA, quality manual QSM, self-inspection, compliance gap analysis, 3rd party audits, Management Review, GMP, GLP,MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 and Validation.
Event Fee: One Dial-in One Attendee Price: US$150.00
Additional details will be posted as soon as they are available.
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