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Connecting People, Science and Regulation ®WINNER,2010 PDA/DHIDistinguishedEditor/AuthorAwardEnvironmental Monitoring:A Comprehensive Handbook,Volume I, II, III, IV, Vand Protocol CDEditor: Jeanne MoldenhauerJeanne Moldenhauer, along withfourteen expert authors, discus therequirements and establishment of anenvironmental monitoring program for the qualitycontrol microbiology laboratory.This comprehensive collection address key topics such asenvironmental trending and the reports needed for manuallytrending data, how to present environmental data to bothinternal and external stakeholders, details regarding thedevelopment of an identification laboratory at your site, andthe latest technology for performing identifications.Chapters include:• Environmental Monitoring of Microbiology Laboratories• Data Management – Small Size Options• Making Sense of Environmental Monitoring Trending Data• Presenting Environmental Monitoring Data to Internaland External Stakeholders• Malidi-Tof Method for Identification of Microbial Isolates• Microbial Identification Laboratory in Supportof an Environmental Monitoring Program• Environmental Monitoring and the MicrobialControl Strategy• Fungal Contamination and Disinfection• And much moreThis book is a welcome addition to any EnvironmentalMonitoring library.Save 20% on your entire purchase price when youbuy the entire five volume set and protocol CD!Bundle of Volume 1, 2, 3, 4, 5 and protocol CD.2011. Item No. 17301Member $1,365 / Nonmember $1,699 / Government $995Available for Individual Purchase:Volume I 2005. Hardcover. 455 pages.ISBN: 1-930114-54-0. Item No. 17211Volume II 2005. Hardcover. 459 pages.ISBN: 1-930114-88-5. Item No. 17237Volume III 2009. Hardcover. 312 pages.ISBN: 1-933722-34-7. Item No. 17285Volume IV 2010. Hardcover. 234 pages.ISBN: 1-933722-45-2. Item No. 17291Volume V, 2011. Hardcover. 213 pages.ISBN: 1-933722-55-X. Item No. 17299Each Volume:Member $335 / Nonmember $419 / Government $290Protocol CD: 2005. 781 pages. Item No. 17238Member $75 / Nonmember $89 / Government $45Validation by Design ® :The Statistical Handbookfor Pharmaceutical ProcessValidationAuthor: Lynn D. TorbeckUnderstand the statistical issuesexpressed and implied in the Foodand Drug Administration’s Guidancefor Industry Process Validation: General Principles andPractices. There is clearly industry confusion and concernabout meeting general regulatory requirements and thispublication answers these questions.Author Lynn Torbeck addresses the guidance in severalunique and helpful ways:• The statistical and quality topics presented are derivedfrom the body of knowledge needed to pass theAmerican Society for Quality (ASQ) exam for the CertifiedQuality Engineer (CQE) certification• Sections of the guidance are rewritten into questions,focusing the attention on how to address the guidancefrom a practical approach• Statistical issues are presented as self-contained standalonemodules rather than an extended narrative• Only the statistical issues expressed or implied in theguidance are addressed• The book provides only information helpful in meetingthe guidance• The National Institute for Standards and Technology(NIST) e-Handbook for Engineering Statistics (NIST, 2009)is highly recommended for study and reference and isused in this publicationIt is an invaluable resource for anyone concerned withstatistical aspects of validating a drug, biologic or animalhealth manufacturing process.2010. Hardcover. 222 pages. ISBN: 1-933722-38-X. Item No. 17266Member $265 / Nonmember $329 / Government $2004 www.pda.org/bookstore

Connecting People, Science and Regulation ®Risk Assessment and RiskManagement in thePharmaceutical Industry:Clear and SimpleAuthor: James L. VesperAuthor James Vesper provides readerswith robust understanding of riskassessment and risk managementbeginning with the history, definitions, how we think aboutrisks and hazards, it gives overview of the risk managementprocess and commonly used risk assessment methods andtools. It also explores the phases of the risk managementprocess in detail and examines how the various toolscan be applied in identifying hazards and evaluatingtheir potential impact and affects. There are examplesthroughout the book that illustrate how the tools can beapplied in “real life”.Chapters include:• A Incomplete history of risk management• Hazards and risks: Concepts and definitionsof important terms• Risks: Perceptions versus reality• Accident theory• An overview of the risk management process• Communication• An overview of risk assessment tools• Evaluation• Control• Monitoring• Risk related documentation and records• Auditing a risk management program• The organization and risk management• And much more.This book defines risk, discusses hazards andrisks, and provides tools to evaluate theseconcepts, while providing the background andcontext necessary to understand the conceptof risk management detailed in the regulatoryguidance documents. It is a useful guide todevelop effective strategies for dealing with riskin the pharmaceutical industry.Russell E. Madsen, President, The WilliamsburgGroup, LLC2006. Hardcover. 292 Pages. ISBN: 1-930114-90-7. Item No. 17219Member $255 / Nonmember $319 / Government $160PDA – The leadingassociation in the fieldof parenteral scienceand technologyDiscover why over 9,500practitioners in thepharmaceutical andbiopharmaceutical industryturn to PDA for their mostimportant professional needs.Join PDAToday –www.pda.org/join!From leading edge information resources,extraordinary network opportunities, one-of-a-kindhands-on training and exceptional online tools,PDA brings together the people, platforms andpaths that lead to better qualified professionalsand a stronger, more dynamic industry.Join today and…• Save sustainably on PDAbookstore products,conferences and trainingcourses• Download all newlypublished PDA TechnicalReports for FREE! *• Receive subscriptionsto the PDA Letter and PDAJournal of PharmaceuticalScience and Technology• Connect to global andregional science andregulatory experts• Become a part ofa leading networkof pharmaceutical andbiopharmaceutical professionals• And so much more!Visit www.pda.org/benefits tolearn more and join us today!* Free downloads are available for 30 days aftera report is published.6 www.pda.org/bookstore

Connecting People, Science and Regulation ®PDA Technical Report No. 48, Moist HeatSterilizer Systems: Design, Commissioning,Operation, Qualification and MaintenancePDAs Moist Heat Sterilization Systems Task Force hasdeveloped a scientific technical report that will help youdesign and operate moist heat sterilizers. This technicalreport focuses on the design and operation of moist heatsterilizers, from the development of User RequirementsSpecifications (URS) through equipment qualification(Installation Qualification (IQ) / Operational Qualification (OQ))and culminating with ongoing maintenance requirements.Advice is offered on the following areas:• Setting User Requirements and Specifications• Design Qualification (DQ)• Equipment and Control System Design• Functional Requirements for the moist heat sterilizerand expectations for utilities supporting the sterilizer• Equipment Operation, including calibration andmaintenance• Equipment Qualification, which may include FactoryAcceptance Testing (FAT), Site Acceptance Testing (SAT),and commissioning• On-going control requirements• Cycle Development2010. 64 pages. ISBN: 9780939459292. Item No. 43487Member $150 / Nonmember $250 / Government $75PDA Technical Report No. 1, Revised 2007,Validation of Moist Heat Sterilization ProcessesCycle Design, Development, Qualificationand Ongoing ControlThis technical report was prepared by the task forcecomposed of 42 European and North American industryand regulatory professionals to ensure the methods,terminology and practices of sterilization science presentedreflect sound science that should be able to be usedglobally. It was disseminated in draft for public reviewand comment prior to publication providing widestpossible review of the document to ensure its suitabilityas a valuable guide to industry in steam sterilization. Itis organized in a logical progression from the essentialelements of sterilization science and technology throughsterilization cycle development and qualification.Section titles include:• Sterilization Science and Technology• Sterilization Process Development• Process Performance Qualification• Ongoing Process Control2007. 54 pages. ISBN: 0-939459-15-9. Item No. 43381Member $150 / Nonmember $250 / Government $75PDA Technical Report No. 51, BiologicalIndicators for Gas and Vapor-PhaseDecontamination Processes: Specification,Manufacture, Control and UsePDA Technical Report No. 51 provides a comprehensive reviewof an area not adequately addressed in current guidancedocuments: recommended specifications for BIs to be usedwith sporicidal gas and vapor-phase decontamination cyclestogether with guidance regarding their manufacture, qualitycontrol, and use. The principles described in this report arebased upon the manufacture and use of BIs prepared fromspore suspensions; however, they can be equally applied tothe preparation of BIs from other sources.2010. 42 pages. ISBN Number: 9780939459322. Item No. 43490Member $150 / Nonmember $250 / Government $75PDA Technical Report No. 44, Quality RiskManagement for Aseptic ProcessesThe methods used to assess risk should be appropriatefor the organization and the process being assessed. Thepurpose of this technical report is to provide an overview ofa quality risk management program and to present a modelto facilitate the risk assessment of aseptic processing ofsterile products. It provides a tool to assess and evaluateactivities, conditions and controls that impact establishingand maintaining aseptic conditions and endotoxin control.Aseptic processing is unique because the severity of theharm is always going to be high and detection of low levelsof contamination is always going to be low.The scope of this report is the application of a quality riskmanagement program to aseptic processing. The quality riskmanagement concepts provided in this report may be usedin other areas of pharmaceutical manufacturing too.2008. 42 pages. ISBN Number: 978-0-939459-20-9. Item No. 43410Member $150 / Nonmember $250 / Government $758 www.pda.org/bookstore

PDA BookstorePDA Technical Report No. 52, Guidancefor Good Distribution Practices (GDPs)For the Pharmaceutical Supply ChainThis technical report describes the overall quality systemfor distribution of pharmaceutical products and is meantto assist manufacturers in assuring that quality, integrity,and efficacy of the product are not compromised inthe distribution channels, including handling, storage,transportation and distribution. It applies to all partiesinvolved, including, but not limited to, the manufacturer,the holder of the marketing authorization, third partyLogistics Service Providers (termed 3PLs), wholesaledistributors, and transportation carriers.Anyone involved with the shipping and distribution ofpharmaceutical products will benefit from this technical report.2011. 36 pages. ISBN Number: 9780939459339. Item No. 43491Member $150 / Nonmember $250 / Government $75PDA Technical Report No. 46, Last Mile:Guidance for Good Distribution Practices forPharmaceutical Products to the End UserThis technical report was prepared by members of the PDALast Mile: Guidance For Good Distribution Practices ForPharmaceutical Products To The End User Task Force.Managing shipments of product in the “last mile” to thepoint of patient administration can prove difficult, butPDA`s Last Mile Task Force has sorted through the variousdistribution regulations in major markets to provideguidance on the proper handling of controlled-temperaturemedicinal products and devices along the final legs of thedistribution chain. This follow-up document to TechnicalReport No. 39 on cold chain management is an invaluabletool to all involved in the “last mile.”2009. 38 pages. ISBN Number: 9780939459261. Item No. 43485Member $150 / Nonmember $250 / Government $75The PDA Journal of PharmaceuticalScience and Technology (The Journal)Journal.pda.orgThe PDA Journal of Pharmaceutical Science and Technology(The Journal), established in 1947, is considered one of themost relevant and highly cited vehicles for peer-reviewedscientific and technical papers in the pharmaceutical andbiotech industries.Housed on the Stanford University’s HighWire Pressplatform, the online Journal features many advancedresearch and application tools including:• Advanced researchtools such as taxonomicbrowsing, contentcollections, sequence andstructure database links,citation mapping and more• High power search tools• Content is displayed infull text HTML pages oras PDFs for maximumflexibility• PowerPoint downloads• RSS feeds• And much more…Journal articles are categorized into the following areas: review,research, technology/application (or case studies), conferenceproceedings, editorial, commentary and letter to the editor, TheJournal is published bimonthly with a circulation of over 9,500.PDA Members receive The Journal as a membership benefitand subscriptions are available to industry, universities, publiclibraries as well as to government agencies.Accessingthe JournalPDA Membership AccessPDA Members receive an individual subscription to the PDAJournal of Pharmaceutical Science and Technology online aspart of their membership fee. The membership subscriptionincludes free access to the current and previous volume year.Nonmember AccessNonmembers can access abstracts, search the current issueand the archives, read articles on a pay-per-view basis, andregister for eTOCs and other Email Alerts, or join PDA for amembership subscription.Institutional SubscribersInstitutions that subscribe to the PDA Journalof Pharmaceutical Science and Technologyonline can register their IP addressesaccording to the terms of their subscription.For more information please visit journal.pda.org or contact +1 301-656-5900 or info@pda.org.Subscribersreceive FREELegacy Contentfrom 1989!www.pda.org/bookstore 9

Connecting People, Science and Regulation ®Multimedia Training ToolsRichard “Dick” Shepherd Training CDsThese programs are developed for pharmaceutical, biopharmaceutical and HCTP operations. Programs may be used forindividual or group training.Quality Assurance Handbook Guidelinefor Production and Control Practicesfor Bulk API ChemicalsThis QA Handbook contains guidelines in two areas involvedwith the production and control of Bulk API Chemicals. Thefirst area covers chemical manufacturing and quality controlresponsibilities for production and control operations forbulk chemicals while the second covers the production andcontrol practices involved in the production of APIs.2011. CD in PDF format. Item Number. 11108Member $200 / Nonmember $240 / Government $150FDA Guide to Inspections of PharmaceuticalQuality Control LaboratoriesThe concepts discussed in this FDA Inspectional Guidancedocument are presented in this training program asindividual issues are addressed to assist laboratorypersonnel, auditors and management in obtaining apragmatic understanding of FDA’s thinking and intentin conducting inspections. A 50-minutes presentationand 236 slides.Item No. 11104Member $300 / Nonmember $360 / Government $150FDA Sterile Drug Process InspectionsProgram 7356.002AThis program provides industry operational groups (QualityAssurance, Manufacturing, Regulatory Affairs and R&D) withFDAs current GMPs interpretations for the manufacture andcontrol of all sterile pharmaceuticals products, includingsterile bulk drugs.This is a narrated slide presentation developed using FDAsSterile Drug Process Inspection Program. It consists of 291slides, is approximately 62 minutes in length and is intendedfor operators, auditors and management.2011. A 62-minutes presentation and 291 slides.Item Number. 11107Member $300 / Nonmember $360 / Government $150FDA Guide to Inspections of MicrobiologicalPharmaceutical Quality Control LabsThis program will serve as a guide to the inspection ofthe microbiology analytical process. It will give laboratorypersonnel, supervisors, auditors, and managers a betterunderstanding of their responsibilities in laboratoryoperations. A 25-minutes presentation and 95 slides.Item No. 11105Member $300 / Nonmember $360 / Government $150FDA Guidance for Industry BioanalyticalMethod ValidationThis training program can be a major tool for initialbiochemical training of analysts, QC, QA and RA personneland for routine training for biochemical analysts,supervisors and managers in bioanalytical validationoperations. A 100-minutes presentation and 216 slides.Item No. 11103Member $300 / Nonmember $360 / Government $150FDA Guidance for Industry: InvestigatingOut-of-Specification (OOS) Test Resultsfor Pharmaceutical ProductionThe guidance document may be used in preparing an SOP forhandling OOS situations. It is also a good source of informationto be used in reviewing current OOS SOPs to update the SOPsas necessary. A 55-minutes presentation and 171 slides.Item No. 11102Member $300 / Nonmember $360 / Government $15010 www.pda.org/bookstore

PDA BookstoreTraining Videos CDs/DVDsAutoclaves – The Science of SterilizingVideo CD Module (Item No. 15864)DVD Module (Item No. 15865)Member/Government $645 / Nonmember $715Autoclaves – The Sterilization ProcessVideo CD Module (Item No. 15867)DVD Module (Item No. 15868)Member/Government $645 / Nonmember $715Correct Behavior in the CleanroomVideo CD Module (Item No. 15836)DVD Module (Item No. 15837)Member/Government $645 / Nonmember $715Gowning for the Cleanroom, Version 2Video CD Module (Item No. 15848)DVD Module (Item No. 15849)Member/Government $645 / Nonmember $715Laboratory WeighingVideo CD Module (Item no. 15860)DVD Module (Item No. 15861)Member/Government $465 / Nonmember $515Working in Clean AirVideo CD Module (Item No. 15844)DVD Module (Item No. 15845)Member/Government $645 / Nonmember $715The PDABookstoreHow to OrderOnline purchasing is quick and easy!To order a publication from this catalogplease visit www.pda.org/bookstore andenter in the item number located at thebottom of the publication description.Fax or Mail:To fax or mail your order please visitwww.pda.org/bookorder and completethe order form using the information inthis brochure or online.For a complete list of publications andmore detailed information please visitwww.pda.org/bookstore. Become a PDAmember and save substantially on yourpurchase order; for more information visitwww.pda.org/join.Working Under GMP Controlled ConditionsVideo CD Module (Item No. 15840)DVD Module (Item No. 15841)Member/Government $645 / Nonmember $715Your First Days at Work with GMP, Version 2Video CD Module (Item No. 15832)DVD Module (Item No. 15833)Member/Government $645 / Nonmember $715www.pda.org/bookstore 11

PDA Global Headquarters4350 East West HighwaySuite 150Bethesda, MD 20814 USAwww.pda.orgTel: +1 (301) 656-5900Fax: +1 (301) 986-1361Inside:PDA Bookstore–Today’s LeadingBio/PharmaceuticalPublicationsand Resources forYour ProfessionalLibraryJoin PDA Today!PDA is a global non-profit organization ofover 9,500 members. Our focus and emphasisis in the areas of sterile product technology,biotechnology and quality and regulatorycompliance concepts and systems –become a part of our community, join PDA today!www.pda.org/join