Description: According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file.About the author:Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging. ABOUT US We are a 501(c)3 non-profit corporation. We sell books and other items donated by our community members to raise money for our local library system. We fund services, reading programs and purchases not in their budget. Our organization has operated continuously in the same city since 1937. PROCEEDS BENEFIT OUR LOCAL LIBRARY PROGRAMS - THANK YOU! Please visit our store for more titles.https://www.ebay.com/usr/friendsofthepaloaltolibrary
Price: 255 USD
Location: Palo Alto, California
End Time: 2025-01-23T19:17:04.000Z
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Item Specifics
Return shipping will be paid by: Buyer
All returns accepted: Returns Accepted
Item must be returned within: 30 Days
Refund will be given as: Money Back
Number of Pages: 160 Pages
Language: English
Publication Name: Validating Medical Packaging
Publisher: CRC Press LLC
Item Height: 0.5 in
Subject: Materials Science / General, Industrial Design / Packaging, Pharmacology
Publication Year: 2002
Item Weight: 13.9 Oz
Type: Textbook
Author: Ronald Pilchik
Subject Area: Technology & Engineering, Medical
Item Length: 9.4 in
Item Width: 6.3 in
Format: Hardcover
