Validation Times

Electronic Licensing Available! Click here

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Now you can examine FDA inspection reports for key validation citations - cleaning, computers, process, utilities, OOS.

Validation Times puts you in the shoes of the FDA field inspector and tells you how your competition fared in an audit.

Validation Times is a monthly newsletter with weekly e-mail alerts.

Your subscription to Validation Times includes:

• News and compliance tips to help you with your validation activities.
• Analysis of FDA 483s, EIRs and key warning letters for validation problems - for drugs, devices, and biologics.

•"Guidance / Regulation Tracker" to keep you posted on the status of pending FDA and key international guidance documents and regulations in the GMP area.
•Regular e-mail alerts concerning GMP / validation and compliance news .
• Discounted pricing on Record Retrieve documents. You can order 483s, EIRs and responses to warning letters anonymously...with no up-front charges.

Sample of our Validation Times online news page, click here.

Subscription Price - $835.00 SPECIAL OFFER! (12 monthly issues)
Price includes 12 issues per year and FREE weekly email updates. You will also receive a FREE copy of the NEW FDA Guide to Systems Based Inspections - a $339 Value - FREE!

Foreign Subscribers: Please add $40 postage. Subscriptions accepted in U.S. dollars only.

Click here to order online or call 703.779.8777.

Editorial Advisory Board:

Elaine Messa
Quntiles Consulting
Irvine, CA

Dr. Ken Muhvich, Ph.D.
Micro-Reliance LLC
Baltimore, MD

Bruce Mackler, Ph.D.
Heller Erhman White & McAuliffe
Washington, DC

Click here to order online or call 703.779.8777.

For any questions or concerns please call 703.779.8777 or email service@fdainfo.com