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

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Category Food, Drugs & Biologics

Deadline: March 11, 2015 | Date: March 11, 2015

Venue/Country: Mississauga, Canada

Updated: 2015-02-27 14:21:18 (GMT+9)

Call For Papers - CFP

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:

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 : supportcompliancetrainings.com

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