Webinar on Hazard Analysis and Product Risk Management under ISO 14971 and ICH Q9

Description :

The U.S. FDA has stated that the use of a medical device or pharmaceutical entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as “practical” / possible, given the ‘state of the art’ at the time. Expectations for meaningful hazard analysis, hazardous conditions and the resulting product risk management documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities, as well as CAPA resolution actions, in the company. High-profile field problems indicate that such activities are not yet adequately planned, executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to “toughen” its approach to product clearance and approval, while reducing liability issues.

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.

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

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