Devicemakers — Recent warning letters point to increased focus on ensuring that your suppliers are delivering validated data and software.
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.
On Jan. 31, 2012, FDAnews hosted 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 listener receives two SPECIAL BONUSES at no additional charge:
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. Order 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 firstname.lastname@example.org.
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