caojuncpu

非常想看一看，可惜这些书都不便宜啊，有电子书吗

cw1980

manzitracy

不过都满贵的

kuang

好东东，但好像广告，没有电子版本，不过

不看脸最帅

顶，我是新人，大家帮忙照顾照顾。。

魅族xxm

有电子书没有的啊？！

未风

现在还可以下载么？我不知道怎么下载：（

ygfyzy

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healt + D, l! W/ k2 m3 l6 w
by Guy Wingate (Editor)7 l" E3 N; x( j% D/ _
" ^$ Y. E" X+ {2 W; u* r
Editorial Reviews& C! _$ q/ P8 Q
6 ]" j9 h* M% P3 \- d" o) ^9 E( q$ v
Review( _# \8 n: ?  p- [
…Whether you are looking for the missing piece of the jigsaw puzzle for your project or guidance on how to meet the regulations in a practical sense, this information resource (which puts principles into practice) is a good place to start!
; ^( h8 u. F$ E  c" B# `- from the foreword by Anthony Trill, Medicines and Healthcare Products Regulatory Agency (MHRA)
7 Q) v6 f1 @6 \0 N2 ?$ y  R% S+ n( D" g. e- p
Product Description, b+ I: f5 _% q9 ^- y: ?
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture. The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge. : [) h- ~7 R- D

" s1 j3 \& e5 o# U! W) YBook Info* i1 O9 C8 v2 m( ]- Z/ E# W
Text provides a comprehensive guide to computer validation, containing more than 200 illustrations and more than 100 tables. Presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. DLC: Pharmaceutical industry--Management.
; _) R9 L& W% f: P
( d0 t# G2 E0 k- Y1 o9 @Product Details' R8 [0 b; e% C8 t9 N/ Z2 P& ^3 e

" z' Y$ R# Z' R- D3 NHardcover: 1032 pages : x- c5 e* g! u, s
Publisher: Informa Healthcare; 1 edition (December 18, 2003)
" H( Q! H4 v! [% b# ]Language: English / I. y0 n' U$ r1 N% h
ISBN-10: 0849318718
' b" t4 B# \  H9 V7 @ISBN-13: 978-0849318719 0 w$ M1 }2 i6 H: b
Product Dimensions: 10.1 x 7.2 x 2.5 inches6 Y1 m$ b1 C( ?0 b
' |4 Y6 i# ~1 Y8 p  y5 M
http://www.amazon.com/Computer-S ... =si3_rdr_bb_product

ygfyzy

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry (Hardcover)
7 ?' M- J0 h" ~( a3 h7 L# C6 zby Orlando Lopez9 B# P6 N2 S7 p; A2 P
0 e/ r1 V6 Z  R; |- G0 I

8 f) s  Y6 w0 r* q8 KEditorial Reviews# I, x3 O+ t0 P# l# i- @
. j* e& H  M6 p9 O( I# Y: q3 p: }
Product Description  H# Z5 ?; a4 E; Q  a2 V
In the FDA regulated environment, it is not acceptable for programmers or their managers to deviate from standardized methodologies. Given the type of software commonly found in FDA regulated operations, the criticality and complexity of computer systems, the evolving regulatory climate, and the current industry best practices, validating computer systems can be problematic. Covering regulatory requirements stipulated by FDA and GAMP guidelines, 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. Whether you need to validate computer systems for pharmaceutical cosmetic, food, or medical devise applications, this book is indispensable. Discussing the regulatory requirements that are the foundation for any project, the book introduces a model that can be used to determine the Part 11 requirements for consideration during implementation. The book establishes a top-down approach to the integration of computer systems validation strategies in support of a computer systems validation project. It focuses on practical issues in computer systems implementation and operational life project management, including relevant activities to comply with Part 11, validation planning, and scheduling. The book reviews documentation in relation to CSV and procedural controls in regulated operations. The book shows how to enable compliance with computer systems validation requirements while highlighting and integrating Part 11 requirements into the entire computer validation program. The author places regulatory compliance within the context of quality assurance and emphasizes the importance of integrating validation into the system lifecycle using a structured top-down approach. This systematic approach helps you efficiently develop compliant software and maintenance its compliance.
) V3 v/ @7 f/ g  ]5 b
: ^+ f( z: E$ ^0 r- w6 v  UProduct Details; A/ o9 z/ V2 z) }/ G  @
; _9 O2 Y2 R( A6 F: M7 a$ W
Hardcover: 243 pages
( j" s4 O% U3 h6 ~* J+ LPublisher: Informa Healthcare; 1 edition (January 15, 2004) 3 C+ u% |+ c) u- W3 ^
Language: English
6 }5 r9 s& a( f, d- M: z+ L1 DISBN-10: 084932243X
7 q+ O( v/ `- M) B0 bISBN-13: 978-0849322433
6 G0 l+ v, z( z1 ?4 S$ tProduct Dimensions: 9.9 x 7 x 0.8 inches / X3 }/ f+ n" w: G! V# ?" l! t4 v

4 P+ T1 [5 T& F5 K2 Uhttp://www.amazon.com/CFR-Part-I ... =si3_rdr_bb_product

ygfyzy

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (1stbooks Library (Series).) (Paperback)6 v  A& h& r- H9 ^9 `  v
by Stephen Robert Goldman (Author) $ o0 Z3 q2 q6 l/ I
2 e) a2 j: b7 L
1 O( Q, X6 `' B$ K% u, j

+ Z- D6 [3 L$ t0 W: w# pEditorial Reviews/ W/ R) G+ y1 n$ c) ]: J( W. \
% Z' Y& r6 x; \6 g( A7 @; K
Book Description; p3 g& [, |$ _, k' u
Much has been written about "why" to validate. The Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry is an SOP-centric explanation of "how" to validate. Creating a state of sustainable compliance with FDA regulations including 21 CFR Part 11, Electronic Records; Electronic Signatures is daunting task. This handbook follows FDA guidelines and "Best Industry Practices" in defining the roles, responsibilities, and requirements of computer and computerized system validation for the pharmaceutical, biotechnology, and medical device industries. It details the requirements for Standard Operating Procedures and Protocols for User Requirements, Functional Requirements, Design Specifications, Installation Qualification, Operational Qualification, and Performance Qualification. 21 CFR Part 11 Assessment and validation gap analysis methods are prescribed to determine the state of compliance of systems with current regulation. The! first requirement of 21 CFR Part 11 is "Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records." This book explains how to comply with this and other requirements of 21 CFR Part 11. 1 Z5 {( o2 }7 e7 e9 F" g
8 h& j! e0 p+ J6 _- c
About the Author
) q# d2 b9 E1 R5 LStephen Goldman is a Senior Compliance Director and Consultant specializing in 21 CFR Part 11 training, assessment, remediation, validation and project management to provide sustainable compliance in the regulated pharmaceutical environment. He has provided Subject Matter Expert guidance and training for gap analysis and remediation of computer systems validation for a major pharmaceutical company under an FDA Consent Decree. He has performed engineering and validation services for two remote data entry systems for use in clinical trials.
( O1 I4 D5 o: L, F7 tHe has managed and conducted numerous training programs for end-user training in basic computer operation and use, network environments, custom Lotus Notes applications, and other specialized programs. He has prepared course material and provides training for an ACPE accredited conference on Planning and Remediation of Systems for Part 11 Compliance and Planning and Checking, Part 11 Assessment and Remediation of Systems for Part 11 Compliance.
& l( q: w+ f6 F2 {" X9 z( I8 f+ m
Mr. Goldman’s background in electrical engineering, manufacturing, defense, pharmaceutical, and biotechnology enables him to relate to most types of business operations. He designs and implements IT solutions to streamline workflows within organizations.
; P1 S( k; w  j! v
: U& l3 X( d5 Q# X+ e% aProduct Details
" s# G. x" o, j2 d1 \
9 |0 U+ a6 y. P  m9 WPaperback: 472 pages + @. r0 u' \; |
Publisher: 1st Books Library (May 16, 2003)
# j: ^6 H& z( q# W% u9 J! CLanguage: English
# H2 |- S! j# n5 W1 _2 l1 wISBN-10: 1410737446
- x/ I5 h+ [. `) T; [3 P! g+ qISBN-13: 978-1410737441 , ]; B6 D, e4 {* P5 ?/ r2 o2 I
Product Dimensions: 10.8 x 8.1 x 1.1 inches1 _" Y% m% k% g- B
& D5 T  O  ~" m& k" g
http://www.amazon.com/Handbook-C ... tical/dp/1410737446

wizardwisdom

问下楼主，这些书您都有？ :em07

huigenghao

Pharmaceutical Master Validation Plan
( N& C% ?5 T5 {2 G( ]' A) z2 l  J& `9 O7 L) s, u9 M! s
General description  
/ |( _% v" A9 y% ]* K" D% O; nPharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products. It supplies valuable text establishing a master plan in compliance with FDA, GMP, and GLP requirements and provides a missing link between the Validation Master Plan to the Validation Standard Operating Procedures and Protocols developed and executed. z& p7 S% f0 l6 [" i
The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States.
) O1 k& |' E; N0 ?' M( }; B9 S% z, z" L0 b7 C
: z! h) u; S9 ?5 m1 s/ U( i
ISBN-10 1574443305 6 _8 m% y: c4 x1 S
ISBN-13 978-157444330-1 9 t$ c2 q! ], N" `5 d( ^$ i+ J) w
publication info S. Haider, CRC Press, 2001, 208 pp., hard cover/CD-ROM" Z, m6 d( u0 X  W. Z1 w

# L0 d  y$ z4 X4 w介绍如下：
( R& f1 S8 o$ V$ I1 _0 lBook Data7 ]0 q, I* t, H0 j3 i6 o

6 n; [  t; S/ X- ]Full Description/ H& h+ c  F* [( ^/ h
The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2 per cent of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market their products in the United States. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance will allow you to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan.The accompanying CD allows users to input the template plan into their computers and tailor it to incorporate additional regulatory requirements specific to individual companies worldwide and print the required documents. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.
/ n/ I8 A) `( `: t* `  eContents ListIntroduction. Concept of Qualification / Validation. Re-Validation. Responsibilities. Facility Description. Description of Building. Utilities Description. Validation Program Overview. Calibration Program Summary. Preventative Maintenance Program Summary. Key SOPs. Validation of Building Test Functions and Acceptance Criteria. Validation of Utility Systems Test Functions and Acceptance Criteria. Process Description: Building A- Dry Oral Products. Process Description Building B- Liquids and Semi Solid Products. Process Description: Building C- Injectables. Qualification of Process Equipment Test Functions and Acceptance Criteria. Validation of Support Process Test Functions and Acceptance Criteria. Quality Assurance / Control Laboratory Validation. GMP Procedures and Programs. Drawings for Building A. Drawings for Building B. Drawings for Building C.

slm009

好东西,先顶了再看

kellysong1983

好贴，顶！

jerome8574

不错的。。。。。