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Seminar & Resource Kit Details

How to Improve Data Quality & Record Integrity in Your NDA, 510(k) or BLA

CD includes the one-hour presentation, a 25-minute Q&A session, plus all the individual slides, reference materials, toolkit items, and a customizable training certificate.  Event ID: 920716

 

Summary

1 out of every 3 FDA preapproval inspections centers on a company's ability to prove the record integrity of their regulatory submission.

Can you prove data integrity to inspectors and agency reviewers?

FDA reviewers and inspectors are trained to expect fraud in your submission.  They'll spend months pouring over the data you claim supports your safety, efficacy and quality decisions.

For 80-90% of submissions, the result is delay or denial.  How will you beat the odds?

Based on the presentation Cerulean's managing director gave with FDA's Helen Winkle last year, this seminar lays out what the agency is looking for when it comes to record integrity problems ... and how to prove that your submission is ready for approval.

Download the detailed agenda (PDF).

You will learn:

• Learn 73 specific questions FDA data integrity reviewers ask of your submission

• Understand how your answers to these questions determines your submission's success

• Recognize the 9 critical challenges you face in your company and in your clinical sites

• Learn the ten steps involved in ensuring data quality in your submission

• Know when and why to conduct independent self-analyses of your submission data

• See why good data quality increases submission approval chances by up to 60%

• Determine how best to head-off most data integrity questions in your submission

• Understand why data monitoring committees are only a fraction of the solution

• Learn what to expect from endpoint adjudication processes

• Lower costs, risks and liability while increasing your chance of FDA approvals

• Put in place a practical strategy right for your organization and your budget

• Understand how incorporating Quality by Design elements will prove record integrity

• And much more

Improve your chances of FDA approval with the tools and techniques in this seminar.

On the CD:

• Customizable training certificate

• Printable speaker's slides (55)

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

• Reference materials, including:

  • 10 recent FDA warning letters

  • FDA presentation on data integrity and fraud

  • FDA presentation on inspecting for good clinical practices

  • FDA presentation on case report tabulation submissions

  • FDA guidance on submitting separate marketing and clinical data applications

  • FDA guidance on early development considerations

  • FDA guidance on good data monitoring committees

  • EMEA guidance on handling missing clinical data

  • ICH E6 Good Clinical Practice Guidance

  • Two recent article reprints ($34 value)

    • Lean Compliance for Midsized Companies

    • Record Integrity and Licensing your Intellectual Property

• Toolkit items for quick and easy implementation:

  • A 3-page regulatory submission data integrity-controls matrix

  • Pre-study data management checklist

  • Post-study data management checklist

  • Pre-submission data management checklist

• And more

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 lean compliance and quality systems management.  He is a frequent and sought-after speaker for corporate management workshops, trade association conferences, business schools, and forums such as FDAnews, FOI Services, PharmaQbD, the Management Roundtable, and Expert Briefings.  He publishes the monthly executive newsletter, SmarterCompliance™, has written more than 100 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™ subscribers view him as their senior  compliance and quality advisor.

 

To Order

For your convenience, we accept payment through PayPal's secure site using any major credit card.  After purchase through the secure site, if you are not automatically redirected, click on the Return to Cerulean link.  If you would prefer to pay with purchase order or invoice and check, please use our quick order form or contact us.

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 this special recorded seminar with all the reference materials is $325 USD (shipping is free).  We accept MasterCard, Visa, Discover, and American Express through PayPal for online payment.

For details on how 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.

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• 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 "Return to Cerulean Associates LLC" link.

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