New EU Annex 11 Rules: Part 11’s Get-Tough European Cousin An Expert Guide to Expanded System Validation, Risk Management and Documentation

Held March 31, 2011

For the first time in EU history, Annex 11 will require your company to manage risks throughout the life of any computerized system used in a regulated activity, effective June 30, 2011.

The new rules will mean retooling validation, risk management and documentation … including everything from electronic signatures and simple spreadsheets to product quality systems and complex, company-wide networks.

Sanctions for noncompliance will be stiff …  so the stakes are high for making your systems and processes compliant.

Bottom line: when the new rules take effect June 30, will you be 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 — in time to make a difference — from Martin Browning, one of industry’s top validation compliance experts and a former FDA investigator.

Learn how to meet new requirements
before the June 30 deadline

Attend New EU Annex 11 Rules: Part 11’s Get-Tough European Cousin on Thursday, March 31, 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:

  • How to mesh new Annex 11 rules with other requirements, including what’s changed in the new Annex 11 rules and how they interact with Part 11, new EU GMP Chapter 4 documentation requirements, and the relationship with quality management expectations of ICH Q8, Q9 and Q10
  • Suppliers and service providers:  what the new rules require, and what can trigger problems for you
  • New expectations: including life cycle risk management and what’s required; periodic validation and IT support of validated systems; new requirements for audit trails, root cause investigations, and more
  • Increased scope: 5 key principles fundamental to coping with the broader scope of Annex 11
  • Practical solutions: 6 elements you must now include in an inventory of your systems; recommended controls for ensuring data integrity; acceptable methods for preventing unauthorized system access; 3 expectations for electronic signatures; and more
  • Trouble-shooting guidelines: document generation, control and retention
  • Impact on legacy systems: are retrospective validations necessary?
  • Roles and responsibilities: How Annex 11 changes the duties of the Qualified Person
  • Preparing for inspections: why your audit reports may be vulnerable — and how to fix them
  • And more

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.

Of course, Mr. Browning will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.
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:

  • Process control
  • Storage and distribution
  • Laboratory testing
  • Quality assurance
  • Documentation
  • Supplier management
  • Batch release and recall
  • Training
  • Regulatory affairs
  • Change control
  • IT and IS
  • Software and development

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

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.

Order now!