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Seminar & Resource Kit Details

Managing Supplier Risk - FDA Expectations

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: 726973

 

Summary

FDA officials are increasing their scrutiny of your records when it comes to controlling your supply chain - from contract manufacturers, raw materials suppliers and consultants.  Recent 483s and Warning Letters have cited firms for failure to qualify and control their suppliers, vendors and professional services.  And the FDAAA 2007 allows the FDA more discretion as to when to fine executives and companies for poor oversight of supplier risk.

How are you protecting your company and your reputation?

This recorded seminar will show you how to put in place a risk-based supplier monitoring program, improve compliance cost-effectively, and reduce risk.  You'll understand why recent FDA enforcement actions were taken and how to avoid drawing the inspector's ire.  Along the way, you will see why certain tactics from peer executives in the SmarterCompliance™ program were successful ... and what you can duplicate in your company.

You will learn:

• What is - and is NOT - working when it comes to managing suppliers

• Key tactics to share the compliance and quality systems burden

• A systematic methodology to align your supplier priorities with your business strategies

• The dangers of ignoring supplier records management

• What the inspector will look for when it comes to your oversight of vendors

• Organizational considerations when it comes to supplier management

• Specific FDA guidance and analyses you can put to work today

• And much more

On the CD:

• Customizable training certificate

• Printable speaker's slides

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

• Regulatory Reference documents:

  • GHTF Guidance - Control of Products and Services from Suppliers

• Literature Reference papers:

  • Article Reprint:  Lean Outsourcing

  • Article Reprint:  Shared Risk - A Regulatory Management Strategy

  • Article Reprint:  Lean Compliance for Midsized Companies

• FDA warning letters citing poor supplier management

• And more

This information-packed, 60-minute recorded seminar will help you control your supplier risks and cut costs from the moment you finish it.

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 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™ subscribers view him as their senior  compliance and quality advisor.

 

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

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