|Quantity Discounts||1 - 9999|
|1 - 9999|
Our buyers have spoken – and we’re responding. By popular demand, FDAnews is rebroadcasting this best-selling event from earlier in 2011.
It’s your best opportunity – and last chance – to attend one of our highest-rated events this year.
More than 300 attended this invaluable webinar the first time around. Here’s what one of our satisfied registrants had to say:
“I liked the overview provided of the whole new Annex 11 and the comparison to 21 CFR Part 11”
Andreas Denk, Manager Regulatory Affairs, eResearchTechnology
Wrap up your 2011 on a high note … with this special one-time-only encore presentation.
For the first time in EU history, Annex 11 now requires your company to manage risks throughout the life of any computerized system used in a regulated activity.
The new rules mean retooling validation, risk management and
documentation … including everything from electronic signatures and
simple spreadsheets to product quality systems and complex,
Sanctions for noncompliance will be stiff … so the stakes are high for making your systems and processes compliant.
Bottom line: are you ready … or at risk?
What new steps and strategies will you need to protect yourself from validation violations under the new EU rules?
Get real-world guidance from Martin Browning, one of industry’s top validation compliance experts and a former FDA investigator.
Learn how to meet new requirements
Attend New EU Annex 11 Rules: Part 11’s Get-Tough European Cousin on Tuesday, Dec. 6, 2011. You and your entire team will come away understanding Annex 11, how it works with Part 11 and other international regulations, and what you and your suppliers must do to comply with these all-new expectations for system validation, risk management and documentation.
BONUS MATERIALS FOR ATTENDEES: Registrants will receive two valuable extra resources: a side-by-side comparison of the new Annex 11 rules and Part 11 rules; plus EduQuest’s latest Client Advisory, Verification vs. Validation: FDA’s Expectations and Why the Difference Matters.
Register now to get your systems and suppliers aligned with today’s all new ground rules for validating computers, networks and software — and for protecting data — including:
A flexible fit for your busy schedule
The New EU Annex 11 Rules webinar 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 office-in-home.
Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget.
You pay one single low registration fee per facility, regardless of how many participate. And every participant gets the two FREE bonuses: the Quick-Glance comparison of Annex 11 and Part 11, plus “Verification vs. Validation: FDA’s Expectations and Why the Difference Matters.” So spread the word to your team.
This webinar offers hands-on guidance of value to executives and personnel in medical device, pharmaceutical and biologics companies, including those involved in:
Martin Browning is the President and Co-Founder of EduQuest, a global team of FDA compliance experts based near Washington, D.C. Martin has more than 30 years of hands-on experience at the FDA and as a highly sought-after advisor to industry. His 22-year career at FDA included work in the field offices as an investigator and in FDA headquarters as a senior manager in the Office of Regulatory Affairs (ORA). He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs.
Martin also served as vice chair of FDA’s electronic record and signature working group, where he helped draft the original 21 CFR Part 11 regulations. In addition, he served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR).
At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering, and compliance auditing, including assessing vendors and outsourced operations.
He is the chairman of many of EduQuest’s popular training courses, including the week-long Compliance Boot Camp presented nationally in cooperation with FDAnews. The course is based on the curriculum EduQuest developed at FDA’s request to train agency field investigators, analysts and compliance staff on Part 11 rules and the inspection of computerized systems.
Martin was named Speaker of the Year by the Institute of Validation Technology (IVT) and has received dozens of other awards from the FDA, DIA, ASQ, and other industry organizations.
|Date:||Tuesday, Dec. 6, 2011|
|Location:||Your office or conference room (no need to travel!)|
|Time:||11:00 a.m. – 12:30 p.m. EST|
|10:00 a.m. – 11:30 a.m. CST|
|9:00 a.m. – 10:30 a.m. MST|
|8:00 a.m. – 9:30 a.m. PST|
|4:00 p.m. – 5:30 p.m. GMT|
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
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Registrations may not be cancelled. Please contact customer service to make any substitutions.
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