2015 - Webinar On FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems
Date2015-01-30
Deadline2015-01-30
VenueOnline, Canada
KeywordsFDA QSR 21 CFR 820; ISO 13485 Requirements; Upcoming changes ISO 13485
Topics/Call fo Papers
Description :
The webinar will also focus on the major difference in expectations between FDA Quality System Regulations and Quality System inspection Techniques (QSR and QSIT) and ISO 13485 for globally distributed products. Proposed changes to ISO 13485 for additional vigilance in areas such as supplier management, risk management and training will be discussed.
Areas Covered in the Session :
You will gain a thorough understanding of:
Requirements of ISO 13485
How to carefully attend to every aspect of the related biomedical standards
Document control
Purchasing Controls
Production controls
CAPA
Identification and Traceability
Upcoming changes ISO 13485:2015
How ISO 13485 differ from FDA QSR 21 CFR 820 requirements
Regulatory expectations of other major growing geographies in the world
Who Will Benefit:
A must attend webinar for Managers, Supervisors, Leads, Specialists, Engineers and Groups in Department of:
Quality Assurance
Regulatory Affairs
Research & Development
Quality Control
Supplier Management
Documentation
Production
Internal Auditors
Quality Auditors
Supplier Auditors
Operations
Manufacturing
Suppliers to medical device industry
Price tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/Product...
The webinar will also focus on the major difference in expectations between FDA Quality System Regulations and Quality System inspection Techniques (QSR and QSIT) and ISO 13485 for globally distributed products. Proposed changes to ISO 13485 for additional vigilance in areas such as supplier management, risk management and training will be discussed.
Areas Covered in the Session :
You will gain a thorough understanding of:
Requirements of ISO 13485
How to carefully attend to every aspect of the related biomedical standards
Document control
Purchasing Controls
Production controls
CAPA
Identification and Traceability
Upcoming changes ISO 13485:2015
How ISO 13485 differ from FDA QSR 21 CFR 820 requirements
Regulatory expectations of other major growing geographies in the world
Who Will Benefit:
A must attend webinar for Managers, Supervisors, Leads, Specialists, Engineers and Groups in Department of:
Quality Assurance
Regulatory Affairs
Research & Development
Quality Control
Supplier Management
Documentation
Production
Internal Auditors
Quality Auditors
Supplier Auditors
Operations
Manufacturing
Suppliers to medical device industry
Price tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/Product...
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Last modified: 2014-12-09 18:21:22