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Seminar & Resource Kit Details

Validation, Data Integrity and Easing Your Pain with IT

CD includes the one-hour presentation and Q&A session with attendees plus all the individual slides, reference material and customizable training certificate.  Speaker: John Avellanet. Event ID: 656173

 

Summary

Earlier this year, one of the top biopharmaceutical and device lawyers in the country called IT departments "the weak link in the compliance chain."

Is your IT department your Achilles heel?

This presentation is designed specifically for non-IT executives and managers struggling to deal effectively with their IT counterparts, particularly when it comes to regulatory compliance and quality systems.

Warning:  this presentation is NOT for IT personnel.  See our Role of IT in Regulatory Compliance webinar if you are in IT.

The seminar offers proven tactics to help you identify where the compliance-IT relationship goes sour, how to successfully draw upon IT to tackle compliance (like 21 CFR Part 11 or HIPAA), and what you can do to turn your IT group into a practical partner focused on business and compliance success.

This recorded seminar presents key takeaways from recent FDA enforcement actions, decades of experience by the speaker and successful tactics from peer executives in the SmarterCompliance™ program.

You will learn:

• Why IT is still known as the "weak link" for regulated industries

• Typical IT mistakes you must seek to avoid at all costs

• The nine roles of a great IT compliance organization ... and how you can get there

• What you can ... and CANNOT ... leave up to IT

• How to help IT map a compliance strategy that fits business needs

• The four questions you MUST have answers to before you fund any IT projects

• How to improve your personal working relationship with your IT colleagues

• And much more

On the CD:

• Checklist:  27-point IT compliance self-assessment

• Template:  21 CFR Part 11 decision-tree

• Template:  Re-usable computer system validation components

• Customizable training certificate

• Printable speaker's slides

• Synchronized audio recording of the presentation and Q&A session

• Audio conference transcript

• Literature Reference papers:

  • Article Reprint:  Preparing for an Inspection of Information Integrity

  • Article Reprint:  SMB Validation - Four Ways to Do More for Less

  • Article Reprint:  Cost Effective IT Outsourcing

• And more

This seminar will help you stay out of trouble when it comes to IT compliance and Part 11.  Never again will you worry about IT being your "weak link."

Your purchase also includes a complimentary six-month trial to the SmarterCompliance newsletter of FDA intelligence, practical quality systems advice, and regulatory compliance analysis ($144 value).

 

About the Presenter

John Avellanet is a well-known leader in IT compliance and lean quality systems management.  He is a frequent and sought-after speaker for corporate management workshops, trade association conferences, business schools, and forums such as PharmaQbD, the Management Roundtable, and Expert Briefings.  He publishes the monthly executive newsletter, SmarterCompliance™, has written more than 30 articles syndicated in biopharmaceutical and device journals world-wide, and is a co-author of the book, Best Practices in Biotechnology Business Development.  Many of his clients and SmarterCompliance™ Toolkit members view him as their virtual "Chief Compliance and Quality Officer."

 

To Order

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CD or Download

CD (default) - $325.00 Download - $325.00

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Additional Details

The purchase price for the recorded seminar is $325 USD (shipping is free).  We accept MasterCard, Visa, Discover, and American Express through PayPal for online payment.

For details on how PayPal secure credit card payment works, see below.

If you have any questions, or would prefer to pay with check or purchase order, contact us.

 

Secure Payment

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• Input your shipping and billing information.  You do not need a PayPal account.

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