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32676 Conferences

21 CFR PART 11: Complete Manual for Compliance Success

Added by davidross759 on 2011-08-26

Conference Dates:

Start Date Start Date: 2011-09-08
Last Date Last Day: 2011-09-08
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2011-09-08

Conference Contact Info:

Contact Person Contact Person: webinar
Email Email: webinars@globalcompliancepanel.com
Address Address: online training webinar, Wilmington, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 3022886884

Conference Description:

How to Prepare and Host FDA Inspections (will cover elements and details of preparation for the inspection as well as elements of the successful practices of hosting an FDA inspection when Part 11 is in scope or the scope of the inspection. We will also cover some commonly asked questions by the inspectors and benefits of being compliant)
Internal and External Auditing for Part 11 Compliance (this subtopic includes all aspects of auditing for Part 11 compliance- starting at the audit program level and then going down on how to prepare for an audit to how to successfully execute the audit and follow up on the completed audit. This subtopic also includes CAPA and responses for the audit findings related to Part 11 - what to expect and handle the difference between "regular" audits and Part 11 audits. We include some of the common audit findings and common pitfalls as well as tools for a successful planning and execution of the audit.)
Audit Trails (includes types of audit trails, strategies for implementing complaint audit trails, proms and cons of audit trails, how to use audit trails as an audit tool during the internal and external audit as well as during the FDA inspection visit, some examples of "should" and "shouldn’t" when it comes to the audit trails and commonly asked questions related to audit trails.)
Overview and Understanding of the Regulation (covers topics such as introduction and development of the regulation, what to expect in the future when it comes to the regulation, options for (non)compliance, "what ifs", as well as most impactful sections and subsections of the regulations.)

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
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