Managing Data Integrity and Part 11 Compliance for Device Suppliers Do It Right or Get a Warning Letter

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Devicemakers — Recent warning letters point to increased focus on ensuring that your suppliers are delivering validated data and software. Read on ...

Device manufacturers — How do you really know if the data and software from your suppliers is actually validated and meets FDA requirements?

The FDA is focusing on the handoff of data and software from suppliers to device manufacturers.  Check out some recent warning letter findings:

  • “Your CAPA investigation failed to evaluate OEM validation review processes…specifically evaluation of software….” (2011)
  • “Your firm failed to assess the failures of [the supplier’s] quality system…including an upgrade of the instrument software.” (2011)
  • “Failure to establish and maintain adequate procedures for validating the device design, including software…. The software used in the microprocessor boards [provided by a supplier] … has not been validated. You [and the supplier] were unable to determine how many software revisions had been released for [your device] and what changes were made during each revision.” (2010)

Validation takes time and money and, by the time FDA flags you or your supplier for unreliable data, it may be too late.  Fortunately, help is around the corner.

Mark your calendar for Tuesday, Jan. 31, 2012, when FDAnews hosts a special training session on data integrity and Part 11 compliance, conducted by the expert many in the device regulation community respect as ‘the best in the business’ — author, speaker and consultant John Avellanet.

Mr. Avellanet runs a crash course on improving data integrity. In 90 whirlwind minutes, you’ll learn practical, easy-to-use information that converts Warning Letter cautions, FDA official statements and investigator questions into real-world processes and valuable benefits. Here’s just some of what you’ll discover:

  • The types of supplier-provided 510(k) submission data the FDA reviews under its Application Integrity Policy
  • Sampling methods the FDA will accept when reviewing supplier-provided data
  • Elements of computer validation protocols the FDA will accept
  • SOPs that ensure proper supplier oversight when it comes to Part 11
  • Red flags that signal when a supplier’s data integrity is failing
  • Records to retain that show FDA your supplier Part 11 oversight meets agency expectations
  • How to maximize control and compliance in light of the growing interrelationship between 21 CFR Parts 11 and 820
  • FDA concerns regarding oversight of suppliers’ computer validation activities
  • Tips when planning to outsource device production and/or clinical testing
  • And much more

Every attendee receives two SPECIAL BONUSES at no additional charge:

  • Checklist of specific Part 11 control points to answer when qualifying a supplier
  • Checklist of elements needed in a supplier’s computer validation plan

Like every FDAnews webinar, Managing Data Integrity and Part 11 Compliance for Device Suppliers is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your home office.

Of course, Mr. Avellanet will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in Part 11 compliance deserves to take part in this event — and they can do so at a cost that won’t break the budget. You only pay one low registration fee per facility, regardless of how many participate — so spread the word.

The rules on Part 11 compliance are evolving. You stay current or risk the consequences — from fines and penalties, to nasty product liability situations. Don’t take those risks — not when it’s so easy and practical to get up to speed. Grab this chance to get the training you and your staff need. Register now.

Spread the word throughout your organization. Make particularly certain to notify the following key staff :

  • QA personnel
  • Regulatory affairs professionals
  • Validation engineers
  • Quality auditors
  • Supplier qualification teams
  • IT audit teams
  • Staff responsible for 21 CFR 820.50 purchasing controls compliance

John Avellanet, Managing Director of Cerulean Associates LLC and a former C-level biopharmaceutical executive, provides practical, business-savvy solutions to strengthen compliance. His book Get to Market Now! is a BIO 2011-featured title. As a consultant, he assists FDA-regulated companies of all sizes in solving Part 11 and data integrity issues and streamlining quality systems. Mr. Avellanet was personally trained by the authors of 21 CFR 11 to conduct FDA inspections, and has himself trained FDA and Health Canada officials. He is a frequent speaker at industry conferences and organizations around the world. For more information, visit Mr. Avellanet’s website at or email specific questions about this webinar to

Register now!

Date: Feb. 6–24, 2012
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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