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Seminar & Resource Kit Details

Lean Outsourcing and Supplier Selection

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: 656162

 

Summary

The FDA has stated that supplier oversight by biopharmaceutical and device executives is one of the agency's top three targets for enforcement.  Warning letters, 483s, recalls and product seizures are increasingly caused by failure to properly manage suppliers and vendors.  Several senators are calling for hearings on stricter corporate and executive penalties for supplier missteps.

So how can you avoid risking your company, your reputation and your customers?

Supplier management is a hot-button issue - not just in the eyes of politicians and regulators - but in terms of cost savings and risk mitigation.

This recorded seminar reveals a successful roadmap to implement a key component of lean compliance and quality systems, vendor selection and oversight.  Based on key takeaways from recent FDA enforcement actions, successful tactics from clients and peer executives in the SmarterCompliance™ program, you will see how to design a risk-based, cost-conscious strategy for supplier selection, how to effectively share the compliance risk, and steps you need to take to ensure vendor accountability.

You will learn:

• What the FDA inspector will look for when it comes to proof of good vendor oversight

• The three crucial supplier lists you MUST maintain

• Why typical risk assessments fall short and lead you astray

• A systematic, statistically based control strategy based on risk and cost

• The six critical compliance controls you must make use of to be taken seriously

• How to structure your vendor management program based on company size

• The key challenges you must overcome at all costs

• 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:

  • ICH Q10 Guidance:  Quality Systems

• Literature Reference papers:

  • Article Reprint:  Lean Outsourcing

  • Article Reprint:  Six Pitfalls to Avoid in Supplier Management

  • Article Reprint:  Shared Risk - An Outsourcing Regulatory Management Strategy

• FDA warning letters citing poor supplier selection and oversight

• And more

This eye-opening recorded seminar will help you stay off the FDA enforcement list, out of the press, and cut costs by 12% while minimizing risk.

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

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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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