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Supplier Qualification: Developing Risk Assessments and Audit Programs That Work

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May 2011
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Can you defend your supplier audit program?

Are you auditing your most critical suppliers rigorously enough?

Are you wasting money and resources needlessly checking up on suppliers that pose little risk?

Here’s how to sort out the regulatory requirements for auditing suppliers in a sensible way that will protect both your products — and your budget.

The FDA is drafting tough new drug GMP standards ... targeting devicemakers with Warning Letters for inadequate supplier qualification and process documentation ... even notifying companies directly when it finds their suppliers are not complying with GMP.

Even if the agency weren’t cracking down, a sound audit program is good business — a way to assure product quality and customer satisfaction, not to mention to avoid multi-million dollar lawsuits.

But in a world where companies manage hundreds of suppliers in dozens of countries, it’s a challenge to maintain audit quality without wasting money on needless audits.

Now you can tighten up your auditing process and keep the FDA out of your hair. This Special Report from FDAnews, Supplier Qualification: Developing Risk Assessments and Audit Programs That Work, will show you how.

It’s a real-world approach — how to design an audit program that works, and is also practical and sustainable.

You’ll discover how to balance major factors that underlie more effective audits — scheduling, selecting auditors, determining when to use outside auditing help, and building an audit program that passes muster with the FDA and other regulators.

Here are just a few of the specifics covered:

  • Developing a risk-based audit program that allows reduced testing for high performers
  • Building an audit schedule that makes the most of tight budgets
  • How to develop a supplier risk assessment tool
  • Tips for selecting and training auditors
  • Sample auditing frequencies using risk-based selections
  • Updates on FDA focus on supplier audit deficiencies
  • Guidance for supplier audits
  • And much more

Don’t wait for the FDA to step in. Don’t expose your company to liability and lawsuits. Take charge of your audit programs now. Order your copies of Supplier Qualification: Developing Risk Assessments and Audit Programs That Work

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