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33841 Conferences

Auditing Systems for 21 CFR Part 11 Compliance - Webinar By ComplianceOnline

Added by Referral on 2011-07-01

Conference Dates:

Start Date Start Date: 2011-08-18
Last Date Last Day: 2011-08-18
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2011-08-18

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

Why Should You Attend:

Can you show me how you manage your computer systems in compliance with 21CFR Part 11?

This presentation will describe a process which has prepared several companies to answer this question from FDA inspectors accurately, completely and to the great satisfaction of the inspectors. We will show how to inventory the site, assess the compliance risk of existing systems, implement new systems, remediate any non-compliance found, prepare SOPs and quality policies, collate the required documentation and train the staff.

Attendees will learn how to prepare and present a concise and comprehensive presentation to regulatory inspectors. Preparation and knowing in advance the expectations and required deliverables for a successful inspection is critical to your pharmaceutical, medical device, biotechnology or software company. Case studies will be presented showing the outcomes for three inspections at companies following this methodology.

Areas Covered in the seminar:

- 21CFR Part 11 Requirements.
- Regulatory Inspections of Computer Systems.
- Required Policies and Procedures.
- Training.
- Performing a Comprehensive Inventory: Team Effort.
- System Inventory Assessment - Preliminary Risk Assessment.
- Compliance Assessment - Compliance Risk Analysis, Gap - Analysis and Corrective Actions.
- Remediation Plans and Schedules.
- Presenting to the Inspector.
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