World Conference Calendar

32676 Conferences

Product Risk Management - ISO 14971 and ICH Q9

Added by Referral on 2010-08-25

Conference Dates:

Start Date Start Date: 2010-08-31
Last Date Last Day: 2010-08-31

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

In this Product Risk Management webinar learn how to develop and implement product risk management planning. Understand the Key requirements of ISO 14971 and ICH Q9.

Areas Covered in the Seminar:

- Key requirements of ISO 14971 and ICH Q9.
- Suggested formats to meet both FDA and MDD requirements.
- Expected sources of information for evaluation and inclusion.
- How to compile.
- When to involve the team.
- How to complete, document and control as a 'living' document.
- An often neglected safety feature.
- Effectiveness -- Determining and Monitoring.
- Realizing real cost savings.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in cGMP and MDD/CE-marking compliance. It will discuss and provide examples of ISO- and FDA/D31ICH-compliant product risk management templates. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

- Senior management
- Regulatory affairs
- Quality Assurance
- Production
- R&D and Engineering
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