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ComplianceOnline Virtual Seminar - 21 Cfr Part 11: Complete Manual For Compliance Success

Added by Referral on 2010-09-17

Conference Dates:

Start Date Start Date: 2010-09-29
Last Date Last Day: 2010-09-29

Conference Contact Info:

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

Conference Description:

This 21 CFR part11 virtual conference will discuss the scope and how to pass a part 11 inspection and how to best use and implement audit trails for part 11 compliance.

Why Should You Attend:
FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities. The number of warning letters is increasing proportionally and we as quality and other professionals utilizing the technology and systems to support our businesses are not ready - we are not ready to prepare and host FDA inspections when Part 11 is in scope, we are unsure how to best use and implement Audit Trails and certainly we have challenges with internal and external auditing for Part 11 compliance.

This webinar will address all these topics and provides you with plenty HOW TO we as auditors and inspectors increase our comfort level with the regulation, with its elements and compliance and practically implement audit system and audit trails - especially since Audit Trails play major role in Part 11 compliance - they can be your best friends and/or worst enemies at the same time.

Duration:

2:00 PM EST - 2:55 PM EST - Module 1 (includes 5-10 min Q&A)
2:55 PM EST - 3:00 PM EST - Break
3:00 PM EST - 3:55 PM EST - Module 2 (includes 5-10 min Q&A)
3:55 PM EST - 4:00 PM EST - Break
4:00 PM EST - 4:55 PM EST - Module 3 (includes 5-10 min Q&A)
4:55 PM EST - 5:00 PM EST - Break
5:00 PM EST - 5:25 PM EST - Module 4 (includes 5 min Q&A)
5:25 PM EST - 5:30 PM EST - Break
5:30 PM EST - 5:55 PM EST - Module 4 (includes 5-10 min Q&A)
5:55 PM EST - 6:00 PM EST - Final Q&A
Who Will Benefit:

Quality Managers
Quality Engineers
Small business owners
CAPA investigators
Inspectors
Six Sigma specialists
Consultants
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