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Daftar Judul DVD Kompilasi Industri 4
 jumlah buku: 100

 

  1. British Pharmacopoeia 2009
  2. European Pharmacopoeia, 5th Ed. Main Volume 5.0, 2005
  3. Japanese Pharmacopeia, 15th Ed (Pharmacopoeia of Japan). Yakuji Nippo Ltd 2006
  4. The International Pharmacopoeia, Vol. 5 (Third Edition). World Health Organization 2003
  5. USP NF 2007 (United States Pharmacopeia 30 / National Formulary 25)
  6. ISO 14001 Environmental Certification Step by Step: Revised Edition. A.J. Edwards 2004
  7. ISO 14001 Environmental Systems Handbook, Second Edition. Ken Whitelaw 2004
  8. ISO 9000 Quality Systems Handbook, 4th Ed. David Hoyle 2001
  9. ISO 9000 Quality Systems Handbook, 5th Ed. David Hoyle 2006
  10. ISO 9001: 2000 in Brief. Ray Tricker 2001
  11. ISO 9001:2000 Quality Management System Design. Jay Schlickman 2003
  12. GLP Quality Audit Manual, 3rd Edition. Milton A. Anderson 2002
  13. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers, Sixth Edition, (Volume 1 - With Checklis). Leonard Steinborn 2003
  14. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 2 - Regulations, Standards, and Guidelines). Leonard Steinborn 2005
  15. Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA Professional. P. Carson 2007
  16. Good Design Practices for GMP Pharmaceutical Facilities. Andrew A. Signore 2005
  17. Good Laboratory Practice Regulations, 3rd Ed. Revised and Expanded. Sandy Weinberg 2003
  18. Good Laboratory Practice Regulations, 4th Ed. Sandy Weinberg 2007
  19. Good Laboratory Practice: OECD Principles And Guidance for Compliance Monitoring. Organisation for Economic Co-operation and Development 2005
  20. Good Laboratory Practice: the Why and the How, 2nd Ed. Jürg P. Seiler 2005
  21. Good Manufacturing Practices for Pharmaceutical: A Plan for Total Quality Control From Manufacturer to Consumer, 5th Ed. Sidney H. Wig 2001
  22. Good Manufacturing Practices for Pharmaceuticals, Sixth Edition. Joseph D. Nally 2007
  23. Good Pharmaceutical Manufacturing Practice : Rationale and Compliance. John Sharp 2005
  24. Pharmaceutical and Medical Device Validation By Experimental Design. Lynn D. Torbeck 2007
  25. Pharmaceutical Engineering Change Control, 2nd Ed. Simon G. Turner 2004.
  26. Pharmaceutical Innovation: Incentives, Competition, and Cost-Benefit Analysis in International Perspective. Frank A sloan 2007
  27. Pharmaceutical Manufacturing Handbook: Regulations and Quality (Pharmaceutical Development Series). Shayne Cox Gad 2008
  28. Pharmaceutical Marketing - A Practical Guide. Dimitris Dogramatzis 2002.
  29. Pharmaceutical Master Validation Plan - The Ultimate Guide to FDA, GMP, and GLP Compliance. Syed Imtiaz Haider, 2002.
  30. Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences). Martin D. Hynes III 2008
  31. Pharmaceutical Process Validation: An International Third Edition (Drugs and the Pharmaceutical Sciences). Robert A. Nash 2003
  32. Pharmaceutical Product Branding Strategies: Simulating Patient Flow and Portfolio Dynamics, Second Edition. Corey Peck 2009
  33. Pharmaceutical Product Strategy: Using Dynamic Modeling for Effective Brand Planning. Mark Paich 2005
  34. Pharmaceutical Project Management (Drugs and the Pharmaceutical Sciences, Volume 86). Tony Kennedy 1998
  35. Pharmaceutical Project Management, 2nd edition (Drugs and the Pharmaceutical Sciences). Tony Kennedy 2008
  36. Quality (Pharmaceutical Engineering Series), Volume 2 . Kate McCormick 2002
  37. Quality Assurance in Analytical Chemistry (Analytical Techniques in the Sciences). Elizabeth Prichard 2007
  38. Quality Assurance in Analytical Chemistry, 2nd Ed. Werner Funk 2007
  39. Quality Assurance in Environmental Monitoring: Sampling and Sample Pretreatment. Ph Quevauviller 1995
  40. Quality Assurance in the Analytical Chemistry Laboratory. D. Brynn Hibbert 2007
  41. Quality assurance of pharmaceuticals: A compendium of guidelines and related materials. Vol 2, Updated edition. WHO 2004
  42. Quality Assurance of Pharmaceuticals: A compendium of guidelines and related materials-Vol 2, 2nd updated edition . WHO 2007
  43. Quality Engineering Handbook, Second Edition, Revised and Expanded (Quality and Reliability). Thomas Pyzdek 2003
  44. Quality Management System Handbook for Product Development Companies. Vivek Nanda 2005
  45. Quality Systems and Controls for Pharmaceuticals. Dipak Kumar Sarker 2008
  46. 21 CFR Part 11 - Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry. Orlando López 2004.
  47. A Primer on Quality in the Analytical Laboratory. John Kenkel 2000
  48. Automation and Validation of Information in Pharmaceutical Processing (Drugs & the Pharmaceutical Sciences). Despautz 1998
  49. Batch Control Systems: Design, Application, and Implementation, 2nd Ed. William M. Hawkins 2006
  50. Batch Processes. Ekaterini Korovessi 2006
  51. Business Development for the Biotechnology and Pharmaceutical Industry. Martin Austin 2008
  52. Combination Products: Regulatory Challenges and Successful Product Development. Smita Gopalaswamy 2008
  53. Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical GMPs (10 Pack).Food and Drug Administration 2005
  54. Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics. Carmen Medina 2004
  55. Computer System Validation. Guy Wingate 2004
  56. Establishing A CGMP Laboratory Audit System: A Practical Guide. David M. Bliesner 2006
  57. Facility Validation: Theory, Practice,and Tools. Graham C. Wrigley 2004
  58. Forecasting for the Pharmaceutical Industry: Models for New Product And In-market Forecasting And How to Use Them. Arthur G. Cook 2006
  59. Get Set & Grow:A Handbook For Medical Representative, 3rd Ed. Vivek Mehrotra 2007
  60. Global Pharmaceutical Marketing - A practical guide to codes and compliance. Judith Grice 2008.
  61. Guidance for the Implementation of a Quality Management System in Drug Testing Laboratories: A Commitment to Quality and Continuous Improvement. United Nations 2009
  62. Guidelines for Auditing Process Safety Management Systems. Center for Chemical Process Safety (CCPS) 1993
  63. Guidelines for Chemical Transportation Safety, Security, and Risk Management. Center for Chemical Process Safety (CCPS) 2008
  64. Guidelines for Implementing Process Safety Management Systems. Center for Chemical Process Safety (CCPS) 1994
  65. Guidelines for Investigating Chemical Process Incidents, 2nd Edition. American Institute of Chemical Engineers 2003
  66. Guidelines for Process Hazards Analysis (PHA, HAZOP), Hazards Identification, and Risk Analysis. Nigel Hyatt 2003
  67. Guidelines for Safe Handling of Powders and Bulk Solids. Center for Chemical Process Safety (CCPS) 2005
  68. Guidelines for the Import and Export of Drug and Precursor Reference Standards for use by National Drug Testing Laboratories and Competent National Authorities. United Nations 2007
  69. Guidelines for The Safe Handling and Disposal of Chemicals Used in the Illicit Manufacturing of Drugs. United Nations Office on Drugs and Crime 2006
  70. Handbook of Production Scheduling (International Series in Operations Research & Management Science). Jeffrey W. Herrmann 2006
  71. Instrumentation and Control Systems Documentation. Frederick A. Meier 2004
  72. Integrating ISO 14001 into A Quality Management System, 2nd Ed. Marilyn R. Block 2002
  73. International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries. Siri H. Segalstad 2008
  74. International Pharmaceutical Registration. Alan A. Chalmers 2000
  75. Inventory Control and Management, 2nd Edition. Donald Waters 2003
  76. Laboratory Auditing For Quality and Regulatory Compliance. Donald C. Singer 2005.
  77. Leading Pharmaceutical Innovation: Trends and Drivers for Growth in the Pharmaceutical Industry, 2nd Ed. Oliver Gassmann 2008
  78. Operations Management. S. Anil Kumar 2009
  79. Principles and Practices of Method Validation (Proceedings of the Joint AOAC/FAO/IAEA/ILJPAC International Workshop). A. Fajgelj 2000
  80. Production and Operations Management, 2nd Ed. S. Anil Kumar 2008
  81. Research and Development Management in the Chemical and Pharmaceutical Industry. Peter Bamfield 2003
  82. Risk-sharing in the Pharmaceutical Industry: The Case of Out-licensing (Contributions to Management Science). Gerrit Reepmeyer 2006
  83. Rules and Guidance for Pharmaceutical Manufacturers and Distributors. MHRA 2007
  84. Six SIGMA for Quality and Productivity Promotion (Productivity Series 32). Sung H. Park 2003
  85. Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics. Brian K. Nunnally 2007
  86. The Laboratory Quality Assurance System, 3rd Ed: A Manual of Quality Procedures and Forms. Thomas A. Ratliff 2003
  87. The Management of Chemical Process Development in the Pharmaceutical Industry. Derek Walker 2008
  88. The Pharmaceutical Regulatory Process, 2nd Ed. Ira R. Berry 2008
  89. The Pharmaceutical Regulatory Process. Ira R. Berry 2005
  90. Total R & D Management: Strategies and Tactics for 21st Century Healthcare Manufacturers. Roger Dabbah 1999
  91. Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers. Guy Wingate 2000
  92. Validating Medical Packaging. Ronald Pilchik 2003
  93. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing. John Andrews 2005
  94. Validation in Chemical Measurement. Paul De Bièvre 2005
  95. Validation of Pharmaceutical Processes, 3rd Ed. James P. Agalloco 2008
  96. Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, 2nd Ed. Syed Imtiaz Haider 2006
  97. Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries. Syed Imtiaz Haider 2002
  98. Warehouse Management: Automation and Organisation of Warehouse and Order Picking Systems . Michael ten Hompel 2007
  99. Who Expert Committee on Specifications for Pharmaceutical Preparations (Technical Report Series). WHO 2008
  100. Write It Down: Guidance for Preparing Effective and Compliant Documentation, 2nd Ed. Janet Gough 2005

 

Bonus

  1. British Pharmacopoeia 2007
  2. Perundangan Kesehatan dan Keselamatan Kerja (K3) - ISO 17025
  3. CleanRooms - Magazines Maret 2008
  4. CleanRooms - Magazines April 2008
  5. CleanRooms - Magazines Mei 2008

 

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