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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:
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:
Every attendee receives two SPECIAL BONUSES at no additional charge:
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 :
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 www.ceruleanllc.com or email specific questions about this webinar to email@example.com.
|Date:||Feb. 6–24, 2012|
|Location:||Your office or conference room (no need to travel!)|
Gather your team for maximum benefit! Your investment is for one dial-in.
Significant tuition discounts are available for three or more sites from
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.
Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600
Registrations may not be cancelled. Please contact customer service to make any substitutions.
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We're always looking for industry leaders eager to share their expertise at an FDAnews audioconference, webinar or physical conference. Our seasoned speaker community includes executives in the pharmaceutical, medical device and clinical trial industries, regulatory affairs, quality control, compliance, healthcare and academia, as well as several former — and current — top FDA officials. Click here to complete our speaker opportunity form and have a representative contact you about future opportunities.
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