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Recorded Seminars

A cost-effective approach to learning the latest best practices.

DVDs can be used by all individuals at one location.  DVDs are usually available within two weeks of the webinar.

Topics

Validation and Data Integrity:  Easing Your Pain When Dealing with IT and Part 11 Compliance

Part of the FDA Expert Briefings for 2007, this audio-conference, recorded in July, provides a review of the current status of the Food and Drug Administration's 21 CFR Part 11, gives insights on improving IT compliance, and presents several practical models you can use to establish and maintain cost-effective electronic compliance and validation strategies.

Speaker:  John Avellanet, Managing Director & Principal, Cerulean

DVD Includes:

• - One hour presentation and audio file

• - Question and answer session with attendees

• - Interview from Pharmaceutical Manufacturing on common information integrity mistakes in clinical trials

• - Preparing for an information integrity inspection - a "how-to" article from the July 2007 SMARTERCOMPLIANCE^™ newsletter

• - Decision-tree for assessing Part 11 compliance needs

• - Diagram of re-usable IT activities that can be applied to meet validation requirements

Price:  $197 USD (outside of the US add $40 for shipment)

 

Simplifying IT Change Control

Part of the FDA Expert Briefings for 2007, this audio-conference, recorded in October, gives you the auditor's expectations of how you manage change and then presents several practical models and best practices to establish and maintain effective and efficient IT change control.  The presentation discusses do's and don'ts for small companies and global, multi-site conglomerates.

Speaker:  John Avellanet, Managing Director & Principal, Cerulean

DVD Includes:

• - One hour presentation and audio file

• - Question and answer session with attendees

• - An auditor's change control checklist (from ISACA)

• - Post-approval change control process overview for multi-site companies

Price:  $197 USD (outside of the US add $40 for shipment)

 

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