— A 2-day hands-on training course
— March 30-31 2006 — Raleigh NC
February 7, 2006 — MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM) — FALLS CHURCH VA USA — Roll up your sleeves for this interactive, hands-on training course, where you’ll apply the Part 11 Toolkit to a sample database – or bring your own database and apply the Part 11 Toolkit to your program.
Ofni Systems’ Part 11 Toolkit makes your existing Access databases compliant with 21 CFR Part 11-electronic records and signatures, FDAnews notes.
You receive an in-depth review of the technical and procedural requirements of 21 CFR Part 11, interpretations of practical applications and demonstrations on how the requirements are met using Access and the Part 11 Toolkit.
SPACE IS LIMITED:
Because this is a hands-on training course with limited computer workstations, space is limited. So register today to ensure you secure a seat. See the entire agenda and register today:
— How to make any existing Access database fully compliant with Part 11
— How to build applications that are robust, secure & compliant
— How to add electronic signatures for a 100% electronic system – say goodbye to paper
— What is expected from a developer’s standpoint when building compliant programs?
— How to migrate existing databases to newer versions of Access, or upsizing to Oracle, MySQL or SQL Server Best practices for validation efforts – learned from industry experience
— And much, much more
SEE THE FULL AGENDA AT:
— Certificate of training in 21 CFR Part 11 (satisfies GxP training requirements)
— Training on best practices in validating Access programs, including tips on what works, what doesn’t work and risk assessment strategies, to help determine how much validation is required
— Comp Evaluation copy of the Part 11 Toolkit
— Comp 2-month subscription to FDAnews’ biweekly newsletter, PharmaDevice IT Report.
MEET YOUR INSTRUCTOR:
Ty Mew, President of Ofni Systems Inc, has been delivering Access applications to FDA-regulated industries for the last 8 years. He has presented audioconferences on how to make Access programs Part 11 compliant for FDAnews and has conducted onsite training for some of the largest companies in the business. Ty has a strong background in computer systems validation and has a BS in chemical engineering with a focus in biochemical engineering from North Carolina State University.
WHO WILL BENEFIT:
— Access developers who want to learn about 21 CFR 11 & how to implement the requirements into their own programs
— Anyone who wants to learn how to build fully Part 11-compliant systems for the pharmaceutical, biotech & device industries.
March 30-31 2006
New Horizons Computer Learning Center
200 Sorrell Grove Church Rd
$1,495 per attendee
3 EASY WAYS TO REGISTER:
Please mention priority code BMN001P11 when registering.
1. Enroll online.
2. Call 703-538-7600 or 888-838-5578. Use your American Express, Visa or MasterCard.
3. Mail your check to:
300 N Washington St Ste 200
Falls Church VA 22046-3431.
You must be 100% satisfied with this learning opportunity, or we’ll refund your entire tuition or extend a credit to a future FDAnews conference.
Written cancellations received at least 1 week prior to the start date of the event will receive a 100% refund, or credit toward a future FDAnews event. After that time, refunds will be subject to a $200 administration fee. Substitutions may be made at any time. No shows will be charged the full amount.
FDAnews is the premier provider of domestic and international regulatory, legislative, business news and 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 international 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