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Seminar & Resource Kit Details

IT Change Control Best Practices

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: 063681

 

Summary

Change control is one of the most challenging aspects of compliance.  Warning letters that deal with electronic records, device software or computerized systems almost always cite failure to adequately control changes.  Being unable to satisfy the inspector's expectations when it comes to controlling your IT environment means making an adulterated product.

Does your IT change control pass muster in the eyes of the FDA?

By knowing the inspector's expectations, you can tailor and streamline your processes - ensuring a positive FDA audit and improved business flexibility.

Designed exclusively for IT executives, quality managers and regulatory compliance directors, this recorded seminar presents key takeaways from recent FDA enforcement actions, successful tactics from peer executives in the SmarterCompliance™ program, and industry best practices.

You will learn:

• What you MUST do - and what NOT to do - to control change effectively

• How the inspector review and checklist works

• Specific records and internal reviews the inspector will look for

• Critical mistakes to avoid at all costs

• Three change control models - based on your company size - that work

• A simple, powerfully-effective framework for post-change review

• And much more

On the CD:

• Template:  Post-Approval Change Control Process

• Customizable training certificate

• Printable speaker's slides

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

• Literature Reference papers:

  • ISACA Best Practice Report:  Auditing IT Change Control

  • Article Reprint:  Part 11 Revised

• FDA warning letters citing poor change control

• And more

This recorded seminar will help you simplify compliance, lower risks, and cut costs.

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 IT Compliance and Quality Officer."

 

To Order

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CD or Download

CD (default) - $325.00 Download - $325.00

 Note:  We use PayPal's encrypted site to process credit card payments - you do not need a PayPal account.

 

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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PayPal® is the world's first and largest encrypted online payment service using credit cards.  PayPal enables individuals and businesses to send and receive payments through encryption over the internet.  No account is required.

Three-step process:

• Click on the "Buy Now" button.  This will take you to the encrypted, secure PayPal site.

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

• After payment is verified and you've see your receipt, you should be automatically redirected to Cerulean - if not, click on the button "Return to Cerulean Associates LLC".

PayPal will also send a copy of your receipt to your e-mail address.

For more details and to watch a video demo, visit the PayPal website.