— An audio conference with former FDA investigator Martin Browning
— Tues Jan 31 2006 — 11 am-12:30 pm EST
January 16, 2006 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — FALLS CHURCH VA USA — Join former FDA investigator Martin Browning on this 90-minute interactive audioconference, Computerized System Validation: When Is Enough, Enough?
Chances are the FDA will target your computer system for auditing. To pass, you must demonstrate that all of your computer applications are validated, along with your network infrastructure and related networks. But with the FDA’s evolving expectations and inconsistent enforcement, what constitutes computerized system validation (CSV) isn’t always clear.
BOOST THE QUALITY, SECURITY & EFFICIENCY OF YOUR OPERATIONS:
Compliance expert Martin Browning shows you how to implement a practical validation plan that audit-proofs your systems, as it helps boost the quality, security, and efficiency of your operations.
With CSV compliance weighing in at more than $2 bln, this audioconference will pay for itself immediately. Browning sorts through the confusion surrounding CSV and shows you exactly how much validation you must carry out — and what you don’t have to do.
TO REGISTER ONLINE:
Register now to turn CSV into a powerful compliance and cost-cutting tool:
WHAT YOU WILL LEARN:
On Tues Jan 31 2006, 11 am-12:30 pm ET, your entire staff can listen in to discover:
— FDA’s definition & intent for CSV
— Today’s best CSV system risk/system risk mitigation techniques
— How to scale your CSV based on system use & risk
— 5 pillars required for effective CSV
— What you must know about the relationship between patient, product & process risk
— How requirements & configuration relate to CSV
— The real relationship between CSV & 21 CFR Part 11
MEET YOUR INSTRUCTOR
Martin Browning is President/Co-Founder of EduQuest. Previously, he worked for 22 years at the FDA as a local, national and intl expert investigator, and then as a Special Asst to the Associate Commissioner for Regulatory Affairs. While at the FDA, he co-chaired the working group that drafted Part 11, served as one of the agency’s national experts on computerized systems. He was also centrally involved in establishing many of FDA’s regulatory approaches, guidance documents, and internal training related to software and computerized systems.
Based on EduQuest’s background and depth of expertise in this area, the FDA hired EduQuest in 2000 to train its field investigators, analysts and headquarters compliance staff on Part 11, plus the auditing of computerized systems. He also served as chair of the US government ISO-9000 committee, on the Global Harmonization Task Force, and on the committee that developed the new medical device GMP regulations (Quality System Regulations).
WHO WILL BENEFIT:
This audioconference is crucial for any drug, biotech, biologic, device or diagnostics company using computerized systems. Must-attend sessions include:
— Compliance officers
— Information technology/services
— Legal personnel
— Management with executive responsibility
— Network system architects
— Quality assurance
— Regulatory affairs professionals
— Risk managers
Date: Tues Jan 31 2006
Location: Your office or conference room (no need to travel)
11:00 am – 12:30 pm EST
10:00 am – 11:30 am CST
9:00 am – 10:30 am MST
8:00 am – 9:30 am PST
4:00 pm – 5:30 pm GMT
24/7 ENCORE(TM) audio presentation will be available 24 hours a day, during Feb 06-24 2006. See options below:
3 EASY WAYS TO REGISTER:
Please mention priority code BMN001CSV when registering.
1. Enroll online:
2. Call 703-538-7600 or 888-838-5578. Use American Express, Visa or MasterCard.
3. Mail your check to:
300 N Washington St Ste 200
Falls Church VA 22046-3431
4 COST-EFFECTIVE TUITION OPTIONS:
All live session participants can receive a certificate of attendance.
1. Audioconference PLUS Audio CD & Transcript: $590 save $200
2. Audioconference Only: $395
3. Audio CD & Transcript Only: $395 (plus shipping and handling)
4. 24/7 ENCORE(TM) Audio Presentation: $395 (Access to 1 dial-in for an archived recording of the entire 90-minute audioconference, including the Q&A period, for unlimited participants. You’ll also receive all presentation materials. Registrants can dial in any time of the day or night for 3 weeks, during Feb 06-24 2006.)
You must be 100% satisfied with this learning opportunity, or we’ll refund your entire tuition, or extend a credit to a future FDAnews audioconference.
FDAnews is the premier provider of domestic and intl regulatory, legislative and business news/information for executives in industries regulated by the US FDA and European Commission. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences, to stay in compliance with intl standards, and FDA’s complex and ever-changing regulations.
FOR FURTHER INFORMATION, PLEASE CONTACT:
300 N Washington St Ste 200
Falls Church VA USA 22046-3431