Description :
This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product, and satisfy U.S. FDA cGMP and CE-marking / Notified Body expectations. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a “living document”.
Areas Covered in the Session :
The Revised ISO 14971 for Devices (with ALARP discussion)
ICH Q9 for Pharma
Product Hazard Analysis
Fault Tree Analysis
Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
Suggested Risk Management File / Report, FMECA, FTA Templates
Why and How to use the ISO 14971 "Model" in all Regulated Industries
The Team and It's Involvement – Who, When and How
Using the Completed Document – It's Real Value “In the Loop”
Q & A session
Who Will Benefit:
This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their developing / reviewing / modifying their product design / formulations, manufacturing processes, and use environment in light of product risk to the end user. Also in addressing their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, Biologics and Combination products fields. The employees who will benefit include:
Senior management
Middle management
R&D
Engineering
Software
QA / RA
Manufacturing
Operators
Consultants
cGMP instructors
And all personnel involved in verification and/or validation planning, execution and documentation.
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@compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1540
Like Us On Facebook:
https://www.facebook.com/events/648409451956155
This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product, and satisfy U.S. FDA cGMP and CE-marking / Notified Body expectations. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a “living document”.
Areas Covered in the Session :
The Revised ISO 14971 for Devices (with ALARP discussion)
ICH Q9 for Pharma
Product Hazard Analysis
Fault Tree Analysis
Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
Suggested Risk Management File / Report, FMECA, FTA Templates
Why and How to use the ISO 14971 "Model" in all Regulated Industries
The Team and It's Involvement – Who, When and How
Using the Completed Document – It's Real Value “In the Loop”
Q & A session
Who Will Benefit:
This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their developing / reviewing / modifying their product design / formulations, manufacturing processes, and use environment in light of product risk to the end user. Also in addressing their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, Biologics and Combination products fields. The employees who will benefit include:
Senior management
Middle management
R&D
Engineering
Software
QA / RA
Manufacturing
Operators
Consultants
cGMP instructors
And all personnel involved in verification and/or validation planning, execution and documentation.
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@compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1540
Like Us On Facebook:
https://www.facebook.com/events/648409451956155
