World Conference Calendar

35127 Conferences

Validating Excel and Word Applications Documents - Medical Device Webinar By ComplianceOnline

Added by Referral on 2010-11-18

Conference Dates:

Start Date Start Date: 2010-12-07
Last Date Last Day: 2010-12-07

Conference Contact Info:

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

Conference Description:

This validation training will discuss FDA impacts and approaches for compliance for use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing.

Areas Covered in the Seminar:

Tougher FDA and EU MDD Software V&V Expectations.
Key COTS Software Apps V&V Requirements.
Problem Areas.
Product, Equipment/Process, QMS and Apps Software and Part 11 Requirements .
Realistic Limits of Apps Software V&V.
Suggested Approaches.
How to Implement, Execute and Document.
Proper Risk Allocation of Scarce Resources.

Who Will Benefit:

This webinar will provide valuable assistance to personnel in all regulated companies responsible for software validation under the cGMPs and EU MDD/CE-marking. This information applies to personnel / companies in the FDA-regulated industries, e.g., Devices, Pharmaceutical, Diagnostic, Biologics and Dietary Supplements. The employees

who will benefit include:

Senior management
Regulatory affairs
Quality Assurance / QAE
Software Implementers
Sales and Marketing
All personnel involved in a U.S. FDA- and/or EU ISO 13485/MDD-regulated environment
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