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PDA Technical Reports - Product Catalog - Parenteral Drug ...

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PDA Technical Reports - Product Catalog - Parenteral Drug ...

PDA Technical Reports No. TITLE Paper Version Digital Version 1 ... 20 Report on Survey of Current Industry Gowning Practices 1990 01020 41239 21 Bioburden Recovery Validation 1990 01021 41258 ... 25 Blend Uniformity Analysis: ...

https://store.pda.org/TableOfContents/PDA_Technical_Reports_list.pdf

Date added: October 8, 2012 - Views: 495

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Technical Report No. 15 Revised 2009 Validation of Tangential ...

Technical Report No. 15 (Revised 2009) ISBN: 978-0-939459-25-4 © 2009 Parenteral Drug Association, Inc. All rights reserved. www.pda.org/bookstore. ... Revised TR–15 is intended to complement PDA Technical Report No. 42, Process Validation of Protein

http://store.pda.org/tableofcontents/tr1509_toc.pdf

Date added: January 14, 2013 - Views: 52

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TECHNICAL REPORT NO . 36 - SDFS Arizona Data Services Program

v TECHNICAL REPORT NO. 36 MAMMALS OF THE QUITOBAQUITO MANAGEMENT AREA, ORGAN PIPE CACTUS NATIONAL MONUMENT, ARIZONA by Yar Petryszyn and E. Lendell Cockrum

http://sdfsnet.srnr.arizona.edu/data/techreports/TECHRPT36.pdf

Date added: October 8, 2012 - Views: 26

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PDA Draft Technical Report No. 29 - Pharmanet

PDA Technical Report No. 29 Points to Consider for Cleaning Validation DRAFT March 30, 1998 TR28_002.PDF

http://www.pharmanet.com.br/pdf/tr29-002.pdf

Date added: April 30, 2012 - Views: 364

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CIP Cycle Development and Cleaning Validation - ISPE

PDA Technical Report #49 - Points to Consider for Biotechnology Cleaning Validation ... • 50 cycle month x (2.5 hr - 2.0hr) / cycle = 25 hrs / month = 275 hr / year

http://www.ispe.org/great-lakes/2012cleaningvalidation.pdf

Date added: September 12, 2012 - Views: 130

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Monitoring isolator air - 800ezmicro - Microbiology International

As a PDA technical report states: “An isolator is sealed or is supplied with air through a microbially retentive filtration system ... whereas the USP 25, Chapter 1116, gives pinhole leaks or tears in gloves as major contamination risk for isolators3.

http://www.800ezmicro.com/component/docman/doc_download/266-monitoring-isolator-air.html

Date added: October 24, 2012 - Views: 26

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“Detection and Mitigation of 2,4,6 PDA: A Global Association

PDA Technical Report No. 55 “Detection and Mitigation of 2,4,6 Tribromoanisole and 2,4,6 Trichloroanisole ... Melamine EFSA TDI 2007 25 mg/day Diethyl phthalate WHO TDI 2003 250 mg/day Diethylene glycol SCF ADI 1986 25 mg/day TBA ...

http://www.piapr.org/clientuploads/10th%20PIA-FDA%20RegConf%20PP%20(June%2021,%202012)/PDA%20Technical%20Report%20No.%2055%20(by%20Anil%20Sawant,%20Johnson&Johnson).pdf

Date added: October 22, 2013 - Views: 4

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Current Issues: Aseptic Processing - PDA

kGy and 25 kGy by a sub-contractant. The validations shown were made in 2000 and there is no guaranty that all the stoppers in the load were ... PDA Technical Report No. 62 (TR 62) Recommended Practices for Manual Aseptic Processes .

http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/current-issues-in-aseptic-processing.pdf?sfvrsn=6

Date added: June 6, 2014 - Views: 2

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Evaluation, Validation and Implementation of New ...

PDA TECHNICAL REPORT NO.33 EVALUATION, VALIDATION AND IMPLEMENTATION OF NEW MICROBIOLOGICAL TESTING METHODS Table of Contents Part One: Selection of New Microbiological Methods

http://cdn2.hubspot.net/hub/54227/file-14538112-pdf/docs/tr33.pdf

Date added: November 22, 2013 - Views: 19

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GRUPO TERRA FARMA, A TRAVÉS DE SUS DIFERENTES FILIALES ...

PDA Technical Report 25, Blend Uniformity Analysis: Validation and In-Process Testing (H112) This report was written to clarify the signi.cant regulatory and technological issues impacting validation approaches and acceptance criteria. 1997, 99 pages.

http://d.yimg.com/kq/groups/15196116/539830601/name/LIBROS_PDA.pdf

Date added: May 3, 2013 - Views: 4

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Technical Report #3 - Penn State College of Engineering

Technical Report #3 Lateral System Analysis and Confirmation Design Matthew R Peyton Page 5 of 54 Structural Systems Foundations The geotechnical report was prepared by Schnabel Engineering, LLC, on March 25, 2010.

http://www.engr.psu.edu/ae/thesis/portfolios/2011/mrp5082/images/Tech3.pdf

Date added: February 14, 2012 - Views: 28

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Meeting Summary PQRI Aseptic Processing Working Group ...

PDA Technical Report No. 13 (Revised), “Fundamentals of an Environmental Monitoring Program” Sept/Oct 2001. ... No 3 (25%) Page 17 of 19 March 4th, 2003 . RECOMMENDATION #9 Concept Paper Line Number Reference: 1448

http://www.pqri.org/commworking/minutes/pdfs/mtc/apwg/022703min.pdf

Date added: April 3, 2012 - Views: 3

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A New Vision - bioMerieux | In Vitro Diagnostics ...

... PDA Technical Report No. 36, Current Practices in the Validation of Aseptic Processing – ... After 8 days at 20-25°C, for both Vegetal an Animal formulations, 100% of the strains grew, whereas the control and other suppliers had much poorer

http://www.biomerieux-usa.com/upload/Media%20Fill%20Brochure-1.pdf

Date added: October 28, 2012 - Views: 12

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Libero. New dimensions. The independent PDF Data Logger.

... conform with PDA Technical Report No 39 ... 25 to 40°C 2 days 8 to 25°C 6 days 2 to 8°C Until expiry 2 to –20°C 2 days Below –20°C Do not use . elproLibero Synergy between Datalogger & Adobe® PDF/A Seite 8 von 12

http://www.teknoistanbul.net/libero.pdf

Date added: May 14, 2013 - Views: 4

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Qualification of temperature-controlled storage areas

2.6.1 Checking installed systems, sub-systems and components ..... 25 2.6.2 Temperature mapping – full ... 5 PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products:

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-qualification-storage-areas-final-sign-off-a.pdf

Date added: June 5, 2014 - Views: 2

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Team LIBERO with internal sensors - Technical Specifications

-25°..+70°C 0..100 %RH Accuracy of device (without any external probe) +/-0.2° in the range of -10°..+25°C ... -5 multiple alarm ranges, conform with PDA Technical Report No 39 (Cold Chain Guidance for Medical Products: Maintaining the Quality of

http://www.nordealer.com/index.php/component/k2/item/download/85_55a6991f01ee6b8032526aa61155b824

Date added: August 5, 2013 - Views: 8

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Temperature mapping of storage areas - World Health Organization

5 PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products: ... temperature range (e.g. hot spots identified between +23°C to +25°C in a room with a specified temperature range +15°C to +25°C). Technical Supplement: ...

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-mapping-storage-areas-final-sign-off-a.pdf

Date added: June 8, 2014 - Views: 1

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In this issue: p~LAL UPDATE® - Associates of Cape Cod, Inc.

Depyrogenation, PDA Technical Report No.3, PDA, Philadelphia, PA). Three parametersappropriatedfrom the theory of sterilization that are frequently encountered in the discussions of depyrogenation are D value. z value and Fvalue. ... 25 0.5 1.5 Time [hr]

http://www.acciusa.com/pdfs/newsletter/LAL_Vol.11No.5.pdf

Date added: March 14, 2012 - Views: 10

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PDA: A Global Temperature Risk Management for the Pharma ...

PDA Technical Reports on Cold Chain / GDP 1. Technical Report No. 39, ... Technical Report No. 53, ... People 12 26 41 22 25 Sorting hub No No No Yes Yes Customs Yes Yes Yes Yes Yes Mode of transport BiTemp Truck Truck, ship,

http://www.decongresbalie.nl/sites/default/files/Presentatie%20deelsessie%201%20E.%20van%20Asselt_0.pdf

Date added: October 8, 2013 - Views: 17

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LIBERO PDF Logger Benefits A most cost efficient solution!

PDA Technical Report No 39 (cold chain guid-ance for medical products: maintaining the ... and 25 °C to 70 °C • Resolution: 1/10 °C • Memory capacity: 16’000 measuring data points • Measurement interval and display renewal:

http://nordealer.com/pdf/elpro_libero_folder_generale.pdf

Date added: May 13, 2013 - Views: 4

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2 Manuscript Title - ECVS INC

13 This article describes a method for achieving the load equivalence model described in PDA Technical 14 Report 1 (TR1), ... 25 minimizing time and qualification requirements for new equipment qualification for similar loads/use,

http://ecvs-inc.com/Library/Risk%20Based%20Approach%20to%20Variable%20Load%20Configuration%20Validation%20in%20Steam%20Sterilization_Final%20Manuscript%20for%20PDA.pdf

Date added: June 7, 2012 - Views: 13

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Technical Assistance Program Guidelines Application

... February 25, 2014 Application deadline: April 2, ... Written Report Technical Tool Adopted Plan/Design Document Other ... The objective of the PDA Technical Assistance Program is to support discrete projects that will advance

http://www.mtc.ca.gov/planning/smart_growth/stations/PDA/Technical_Assistance_Program_Guidelines_Application.pdf

Date added: January 31, 2014 - Views: 2

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2007-06-13 NEPDA TR40 Sterilizing Gas Filtration Leesa McBurnie

PDA Technical Report 40 Sterilizing Filtration of Gases • Published Jan/Feb 2005 • Educational guide to complement TR26 ... PVDF 25 PTFE 18 Critical surface tension (dynes/cm) Polymer. Pore size ratings • True pore size should not be confused with

http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/tr40-sterilizing-filtration-of-gases-a-comparison-with-tr26-sterilizing-filtration-of-liquids.pdf?sfvrsn=6

Date added: June 27, 2014 - Views: 1

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The Parenteral Drug Association presents 2013 PDA Europe ...

special group rate until 25 January 2013, Code: PDA. Reservation link: Marriott Hotel Housing at the selected hotel will be in high demand, ... 11:30 About RMM Validation/Technical Report No. 33 Michael Miller, Microbiology Consultants 12:00 Q & A, Discussion

http://www.tiselab.com/pdf/2013_Microbio_Brochure.pdf

Date added: November 13, 2013 - Views: 12

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Way Out West - Western Pallet Association

A new pharmaceutical industry technical report has been published to Tom Worthen President ... The Report, PDA Technical Report No. 55 (TR 55) ... 9/26/2012 12:17:25 PM ...

http://www.westernpallet.org/newsletters/sept12wow.pdf

Date added: July 22, 2013 - Views: 11

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Autoclaves Qualification & Validation - Надлежащая ...

PDA Technical Reports • PDA Technical Report No. 1, ... →→→→ Approval of DQ protocol and report respective approval of URS/FDS comparison by defined persons ... 25 of 39 Autoclaves: Qualification & Validation Holger Fabritz ...

http://www.gmpua.com/Equipment/Sterility/Sterilization/QualificationofAutoclaves.pdf

Date added: October 19, 2011 - Views: 143

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Case Study: Computer Supplier Evaluation Practices of the ...

5.3 Other Lessons.....25 6 Conclusion ... Audit Audit performed in accordance with PDA Technical Report No. 32 and brokered by ARC for participating suppliers or supplied by

http://resources.sei.cmu.edu/asset_files/TechnicalReport/2003_005_001_14234.pdf

Date added: October 28, 2013 - Views: 1

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Terminal Sterilization vs. Aseptic Processing

Source : PDA Technical Report #36: Current Practices in the Validation of Aseptic Processing - 2001 85% 2% No 67.4% Yes ... absorbed minimum dose of ≥25 KGy ? Use pre-sterilised individual components and aseptic compounding and filling Use sterilisation at 160 oC

http://forums.pharmacyonesource.com/phos/attachments/phos/pharmacy_ops/1377/1/terminal%20sterilization%20v%20aseptic.pdf

Date added: June 4, 2012 - Views: 93

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Developing Thermostable Vaccines

25.0% 32.1% Includes delivery of antiretroviral (ARV) drugs Includes injectable contraceptives Includes oxytocin in Uniject™ ... PDA Technical Report 39 (2007) Pharma Industry Survey (2009) Long-Term Guidance Guidance References ICH and WHO Follow ICH

http://mediaserver.aaps.org/meetings/2010PSWC/Slides/11-15-Monday/1330_sessions/Room_244-245/Chen.pdf

Date added: May 11, 2013 - Views: 15

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Exhibitor’s Special - Lighthouse Instruments

Technology Transfer – PDA Technical Report 30 26 June All Participants 495 One-Day-Training Course ... Parenteral Manufacturing 24-25 June All Participants (No PDA membership included) 935 Group Registration Discount Register 4 people from the same site as a group (at

http://www.lighthouseinstruments.com/uploads/documents/2014_ParManu_RegForm_LIG_Apr29_feb.pdf

Date added: June 27, 2014 - Views: 1

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PDA Letter • February 2007 Science & Technology Articles of ...

preservatives tested were 0.25% ... PDA Technical Report # 28 (Revised) Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals. PDA. ... To purchase this or any PDA/DHI technical books, go to www.pda.org/bookstore. Title: untitled

http://www.microbiol.org/wp-content/uploads/2010/07/sutton.pda_letter.0702.pdf

Date added: March 9, 2012 - Views: 11

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FDA & Regulatory Compliance: F CliFocus on Cleaning

PDATechnical Report No. 29: ... 25. Increased FDA Focus on Cleaning-Related Issues: 1) Inadequate, inconsistent manual cleaning. 2) Inadequate scientifically-based cleaning cycle dl tti ldevelopment rationale. • Analytical methods

http://mcflusion.com/images/FDA_and_Regulatory_Compliance.oct.2006.pdf

Date added: May 7, 2012 - Views: 2

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Report # MATC-UI: 117 Final Report - Mid-America ...

Technical Report Documentation Page 1. Report No. ... Performing Organization Report No. 25 -1121 0003 117 9. Performing Organization Name and Address ... PDA personal digital assistant PRT personal rapid transit RSU road-side units

http://matc.unl.edu/assets/documents/matcfinal/Schwarz_TowardsAutonomousVehicles.pdf

Date added: February 15, 2014 - Views: 2

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The Impact of the Microchip – Application of Modern ...

PDA Technical Report No. 14, Validation of Column-based Chromatography Processes for the Purification of Proteins 2:45 p.m - 3:15 p.m. ... 25 Red Rock Casino, Resort and Spa 11011 West Charleston Las Vegas, Nevada 89135 Phone: +1 (702) 797-7777

http://www.pharm.chula.ac.th/tjps/images_pharmacy/file2.pdf

Date added: April 1, 2014 - Views: 4

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LIBERO: Innovation Leader in Cold Chain Monitoring

- Temperature range -25°C..+70°C - Humidity range 0%..100% - Life time: 3 years, 400 or 100 days (single use) ... to PDA Technical Report No 39 -Validation certificate-IQ/OQ documentation is made available IT Manager: Reliability and seamless

http://www.elpro.com/uploads/tx_elproproducts/LIBERO_Innovation_Leader_02.pdf

Date added: May 19, 2013 - Views: 1

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Human Factors Guidance for the Use of Handheld Portable and ...

Technical Report This document is available to the public through the National ... 25 List of Illustrations Figure Page Figure 1. Typical interaction with a PDA, ... PDA Personal Data Assistant . Title:

http://hf.tc.faa.gov/technotes/dot_faa_ct_05_15.pdf

Date added: February 12, 2012 - Views: 13

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Quality Control: Certified NRCM Workforce - Certification

The PDA Technical Report No. 35 discusses a competency-based training approach, “A crucial ... scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.25 NRCM Website - http://www.microbiologycert.org/ nrcm.asp Nicoll, T, D Ransom and D Singer. 2005. Path for

http://www.microbiologycert.org/documents/PMFNewsApril09article.pdf

Date added: March 27, 2012 - Views: 8

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PERU ALTERNATIVE DEVELOPMENT PROGRAM (PDA)

DEVELOPMENT PROGRAM (PDA) Final Report USAID Contract no. 527-C-00-04-00043-00 ... Then, the PDA program arrived, offering technical assistance and teach- ... 25 percent less than the bud-geted amount.

http://www.chemonics.com/OurWork/OurProjects/Documents/Peru_PDA_Final_Report.pdf

Date added: August 17, 2013 - Views: 2

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Training to Excellence - Nanyang Polytechnic

in PDA Technical Report No. 1) to basics of good sanitary design. In addition to discussion ... 25 May 2014 / 18 August 2014 DATE: 29 - 30 April 2014 LOCATION: Pall Singapore, Centre of Excellence. Science Park II, The Gemini Building, #01-29

http://www.nyp.edu.sg/pdc/display_file.cfm?file_name=NYP+-+Pall+Training+Brochure+2014.pdf&ff=Y

Date added: April 6, 2014 - Views: 1

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A Consensus Rating Method for Small Virus-Retentive Filters ...

final consensus filter method was published in the 2008 update of PDA Technical Report 41. Virus Filtration. KEYWORDS: Virus retentive filtration, Virus safety, Bioprocessing ... absolute for 20-nm to 25-nm viruses and that non-absolute filters are known to show a range of particle or ...

http://www.mrzgroup.umd.edu/pdfs/2008_PDA_virus.pdf

Date added: April 3, 2014 - Views: 1

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Supplier Assessments Audits - İKEV

PDA Technical Report 32 1. Quality System 2. Project Management 3. Methodology 4. Testing 5. Configuration Management 6. Manufacturing 7. ... Computerized Systems Validation Supplier Assessment 25 Dr. Guenter Generlich After the Audit

http://www.ikev.org/haber/2003valid/10%20Supplier%20Audits.pdf

Date added: March 25, 2012 - Views: 90

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PMF NEWSLETTER - The Microbiology Network | Dedicated to the ...

taminated (PDA Technical Report No. 51). The bio-logical indicators used can be readily enumerated. The micro-organism used must be appropriate, that is ... has nearly 25 years of experience in the GMP industry, in-cluding Quality Control Microbiology, Quality Assurance

http://www.microbiologyforum.org/content/file/PMFNews.17.05.1105.pdf

Date added: December 8, 2013 - Views: 1

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Technical Report 47 – “Creating a Research Database on ...

TOOLS: TECHNICAL REPORT NO. 471 By Elizabeth A. Ruff, M.S./Ed.S. Robert C. Reardon, Ph.D. Sara Cummings Bertoch, M.S./Ed.S. November 5, 2007 The Center for the Study of Technology in Counseling and Career Development ... 25 Melissa Lewis ...

http://career.fsu.edu/documents/technical%20reports/Technical%20Report%2047/TR47.pdf

Date added: October 30, 2011 - Views: 47

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PDA Forensic Tools - NIST Computer Security Division ...

... and technical analysis to advance the ... etc.), a timeline, and the generated report from the script. 25. Graphics Library After a script to find all examiner ... an Overview and Analysis; computer forensics; forensic software; forensic toolkits; PDA; Personal Digital Assistant

http://csrc.nist.gov/publications/nistir/nistir-7100-PDAForensics.pdf

Date added: February 14, 2012 - Views: 38

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/tardir/tiffs/a416880 - DTIC

the company had needed 25 people at each of its manufacturing sites. ... Audit performed in accordance with PDA Technical Report No. 32 and brokered by ARC for participating suppliers or supplied by subscribers as required by their level of subscription

http://www.dtic.mil/cgi-bin/GetTRDoc?AD=ADA416880

Date added: November 29, 2013 - Views: 4

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20030329-01A Pharma and Life Sciences - Надлежащая ...

H NS 35000 200 0 NS 25 15 10 ... PDA Technical Report No. 13 Fundamentals of a Microbiological Environmental Monitoring Program ... report a size larger than 0.5µ and only one count. Coincidence Error. www.golighthouse.com

http://www.gmpua.com/CleanRoom/Monitoring/PharmLifeSciences.pdf

Date added: January 3, 2012 - Views: 34

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Kleenpak™ Nova Filter Capsules with Pegasus™ SV4 Virus ...

Fully encapsulated format Reduces operating costs, no cleaning validation required ... with up to 25 g.L-1 (2.5 %) MAb ... (PDA) Technical Report 41 rating method for small virus-retentive filters.

http://www.pall.com/pdfs/Biopharmaceuticals/SV4_Kleenpak%20Nova_SS_USD2856.pdf

Date added: June 17, 2013 - Views: 2

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Staffing Assistance Program Guidelines Application

following regional programs - PDA Planning Program, PDA Technical Assistance, and PDA Staffing Assistance. ... February 25, 2014 Application deadline: April 2, ... Adopted Plan Written Report Technical Tool Design Document Other ...

http://www.mtc.ca.gov/planning/smart_growth/stations/PDA/PDA_Staffing_Assistance_Program_Guidelines_Application.pdf

Date added: February 15, 2014 - Views: 1

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PROFESSIONAL SERVICES AGREEMENT between METROPOLITAN ...

pda technical and staffing assistance . fiscal years 201__-201__ to 201___-201___ ii . ... 25. choice of law ... attachment h-4, final report-utilization of disadvantaged business enterprises (dbe) ...

http://bids.mtc.ca.gov/download/680

Date added: February 12, 2014 - Views: 4

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Oregon Research Institute

ORI TECHNICAL REPORT Vol. 48 No. 1 March 2008 . 1 ... The 525-PDA, a set of the 500 most familiar English person-descriptive adjectives (Saucier, 1997), ... (25) Experimental Personality Survey (EPS), which included 256 new IPIP items

http://projects.ori.org/lrg/PDFs_papers/ORI_TechnicalReport_ESCS_Mar08.pdf

Date added: May 3, 2013 - Views: 12