Picture 1 of 1
Gallery
Picture 1 of 1
Validating Medical Packaging, Hardcover by Pilchik, Ronald, Like New Used, Fr...
US $307.45
Approximately£226.55
Condition:
Like New
A book that has been read, but looks new. The book cover has no visible wear, and the dust jacket (if applicable) is included for hard covers. No missing or damaged pages, no creases or tears, no underlining or highlighting of text, and no writing in the margins. May have no identifying marks on the inside cover. No wear and tear. See the seller’s listing for full details and description of any imperfections.
- Buy it nowValidating Medical Packaging, Hardcover by Pilchik, Ronald, Like New Used, Fr...
Oops! Looks like we're having trouble connecting to our server.
Refresh your browser window to try again.
Postage:
Free USPS Media MailTM.
Located in: Jessup, Maryland, United States
Delivery:
Estimated between Sat, 28 Jun and Tue, 8 Jul to 94104
Returns:
14 days return. Buyer pays for return postage. If you use an eBay delivery label, it will be deducted from your refund amount.
Payments:
Shop with confidence
Seller assumes all responsibility for this listing.
eBay item number:365565290579
Item specifics
- Condition
- Book Title
- Validating Medical Packaging
- ISBN
- 9781566768078
About this product
Product Identifiers
Publisher
Taylor & Francis Group
ISBN-10
1566768071
ISBN-13
9781566768078
eBay Product ID (ePID)
2215909
Product Key Features
Number of Pages
160 Pages
Language
English
Publication Name
Validating Medical Packaging
Publication Year
2002
Subject
Materials Science / General, Industrial Design / Packaging, Pharmacology, Biomedical
Type
Textbook
Subject Area
Technology & Engineering, Medical
Format
Hardcover
Dimensions
Item Height
0.5 in
Item Weight
13.9 Oz
Item Length
9.4 in
Item Width
6.3 in
Additional Product Features
Intended Audience
Scholarly & Professional
LCCN
2002-073339
Dewey Edition
21
Illustrated
Yes
Dewey Decimal
681.761
Table Of Content
INTRODUCTION. What is Validation? PACKAGE DESIGN VALIDATION. Elements of Package Design. Package Design Issues. Validation Flow Chart. Simulation Criteria. Qualified Suppliers. PACKAGE PROCESS VALIDATION. Introduction. Process Validation. IQ, OQ, PQ. Process Capability Studies. Example. PUTTING IT ALL TOGETHER: THE VALIDATION PROTOCOL. The Validation File. File Maintenance. Employing the Process. Example. REGULATORY ACTIVITIES. Selected Case Studies. Packaging Non-Compliances. Industry Generated Support Documents. HACCP. Appendix.
Synopsis
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., The FDA establishes the manufacturer's responsibility for medical device packaging, but provides no direction on how to achieve compliance. Highlighting the recent development in industry regulations, this book demystifies the validation procedure. The author presents real-life examples and case studies, templates for creating and maintaining a validation file, and explains how the process and regulation works. He addresses the specific needs for validation of packaging for medical devices and covers laws, regulations, guidelines, and process capability studies. The book shows readers how to develop and implement a simple validation process for package design and processing.
LC Classification Number
R857.P33P54 2002
Item description from the seller
Seller business information
About this seller
Great Book Prices Store
96.6% positive Feedback•1.3M items sold
Registered as a business seller
Seller Feedback (381,374)
- l***1 (1465)- Feedback left by buyer.Past 6 monthsVerified purchaseGreat seller; book exactly as described in mint condition sold at a reasonable price; seller shipped item FAST, FREE and with tracking information, a must nowadays; seller shipped in tight, cardboard mailing envelope, which tightly fit over the book, preventing damage in shipment; good communication too; rate seller 10+++++Cuentos de La Habana Elegante, Brand New, Free shipping in the US (#364594098367)
- y***t (1858)- Feedback left by buyer.Past 6 monthsVerified purchaseI purchase the Veterinary Assisting Fundamentals & Applications, Hardcover by Vanhorn, Beth on January 22nd and it took five days which was January 27th to confirm my order, provide a tracking . Once, that happend the textbook sat somewhere 4 more days before it was shipped , it was suppose to arrive Monday, January 3rd, Great seller. Great price, As described, Packed well.Veterinary Assisting Fundamentals & Applications, Hardcover by Vanhorn, Beth,... (#384492381860)
- p***l (819)- Feedback left by buyer.Past 6 monthsVerified purchaseItem as described. Poly mailer, no padding. Description clearly states delivery window of several weeks. Yet I chose this seller because item is new. Purchased/paid April 16, shipped April 28, arrived Maryland to SC May 5.This after contacting seller on day 10 to ask why it had not shipped yet. Slow return communication requesting invoice number/transaction date. Just be aware. IMHO eBay has sellers with faster, more efficient delivery service.
Seller Feedback (381,374)
- l***1 (1465)- Feedback left by buyer.Past 6 monthsVerified purchaseGreat seller; book exactly as described in mint condition sold at a reasonable price; seller shipped item FAST, FREE and with tracking information, a must nowadays; seller shipped in tight, cardboard mailing envelope, which tightly fit over the book, preventing damage in shipment; good communication too; rate seller 10+++++Cuentos de La Habana Elegante, Brand New, Free shipping in the US (#364594098367)
- y***t (1858)- Feedback left by buyer.Past 6 monthsVerified purchaseI purchase the Veterinary Assisting Fundamentals & Applications, Hardcover by Vanhorn, Beth on January 22nd and it took five days which was January 27th to confirm my order, provide a tracking . Once, that happend the textbook sat somewhere 4 more days before it was shipped , it was suppose to arrive Monday, January 3rd, Great seller. Great price, As described, Packed well.Veterinary Assisting Fundamentals & Applications, Hardcover by Vanhorn, Beth,... (#384492381860)
- p***l (819)- Feedback left by buyer.Past 6 monthsVerified purchaseItem as described. Poly mailer, no padding. Description clearly states delivery window of several weeks. Yet I chose this seller because item is new. Purchased/paid April 16, shipped April 28, arrived Maryland to SC May 5.This after contacting seller on day 10 to ask why it had not shipped yet. Slow return communication requesting invoice number/transaction date. Just be aware. IMHO eBay has sellers with faster, more efficient delivery service.