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Basic Principles of GMP - World Health Organization

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Basic Principles of GMP - World Health Organization

Title: Basic Principles of GMP Subject: WHO template and recommendations Keywords: communication, photos, text Last modified by: Angela Maria Ferreira LOPES

http://www.who.int/prequal/trainingresources/pq_pres/gmptraining/M11A.ppt

Date added: October 31, 2011 - Views: 583

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Basic Principles of GMP - World Health Organization

Title: Basic Principles of GMP Subject: WHO template and recommendations Author: loconte Keywords: communication, photos, text Last modified by: Alexander Polishchuk

http://www.who.int/prequal/trainingresources/pq_pres/Tallinn-Oct07/GMP_inspections_en.ppt

Date added: October 10, 2011 - Views: 404

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Basic Principles of GMP - World Health Organization

... health and clothing practices waste disposal Implementation and training ... Basic Principles of GMP Active Pharmaceutical Ingredients Active ... Basic Principles of GMP Active Pharmaceutical Ingredients Active Pharmaceutical Ingredients Active ...

http://apps.who.int/prequal/trainingresources/pq_pres/gmptraining/M15-A.ppt

Date added: October 31, 2011 - Views: 55

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Basic Principles of GMP - World Health Organization

... Calibration and operation of analytical apparatus Maintenance, cleaning and sanitation Personnel recruitment, training, ... Basic Principles of GMP Author: David Richard Buckley Last modified by: Alexander Polishchuk Created Date: 3/17/2000 11:45:32 AM

http://apps.who.int/prequal/trainingresources/pq_pres/workshop_Russia/M02-QA-doc-2-f_U.PPT

Date added: March 28, 2012 - Views: 54

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Basic Principles of GMP - Tripod.com

Basic Principles of GMP Documentation - Part 1 Workshop on GMP and Quality Assurance of HIV products Shanghai, China 28 Feb - 4 March 2005 Maija Hietava M.Sci.Pharm ... Qualifications and Training ...

http://barry-bw.tripod.com/documentation.ppt

Date added: May 16, 2013 - Views: 26

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Basic Principles of GMP - u-szeged.hu

Basic Principles of GMP ... Calibration and operation of analytical apparatus Maintenance, cleaning and sanitation Personnel recruitment, training, clothing and hygiene Environmental monitoring Pest control Complaints Recalls Returned goods.

http://www2.pharm.u-szeged.hu/gyfi/minbiz/eng7gmp5.ppt

Date added: August 27, 2013 - Views: 37

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Basic principles

Radiopharmaceutical Production. Content. US FDA Philosophy. Radiation protection and facility design. GMP and facility design. Cleanrooms and facility design

http://www-naweb.iaea.org/napc/iachem/training-modules/Facility_Equip%5CFacility%20Areas%5CProduction_Environment_US.pptx

Date added: June 3, 2013 - Views: 25

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Validation - Надлежащая ...

Supplementary Training Modules on Good Manufacturing Practices Validation Validation Objectives of Part 1 To provide an introduction to the subject of Validation To provide information on the Validation Master Plan Validation Introduction Three basic principles of Quality Assurance: Quality ...

http://www.gmpua.com/Validation/Presentation/Validation01.ppt

Date added: November 13, 2011 - Views: 106

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Quality Systems Approach - NEW ENGLAND SOCIETY OF COSMETIC ...

ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM ... Laos PDR Davong Oumavong ... Principles of Quality Management Basic Principles of Quality Assurance Basic Requirements of Quality Assurance Basic Principles of GMP Basic Requirements of GMP Basic Principles of Quality Control ...

http://www.newenglandscc.org/images/Cosmetic_GMP_Implementation_Part_2.ppt

Date added: June 10, 2012 - Views: 71

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temp.ppt - FUTURE BEACON

... 10 minutes for each group to make its presentation. At the end of each of the modules on Basic Principles of GMP (except this one) ... I want to prepare two GMP training modules for use in my own country by the year 2003. Show how this is specific, measurable, action-oriented, realistic and ...

http://test.futurebeacon.co/wp-content/uploads/2012/10/M01.ppt

Date added: June 15, 2013 - Views: 20

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ASEAN GMP GUIDELINE

ASEAN Cosmetic GMP Team ... 21 November 2002 SUPPLEMENTARY ASEAN GMP TRAINING MODULE EQUIPMENT SANITATION EQUIPEMNT SANITATION The main principle for equipments should be that it is ... cross contamination mix-up * ASEAN Guideline for Cosmetic GMP, 2003 WHO Basic Principle of GMP ...

http://filing.fda.moph.go.th/library/e-learning/CCD/GMP%20Sanitation%20Equipment.ppt

Date added: December 3, 2011 - Views: 94

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ASEAN GMP TEAM FRANCE BENCHMARKING 23 – 29 October 2005

ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM Prepared by Hui Foong Mei – Singapore Vongsavanh Insixiengmay – Laos PDR Davong Oumavong ... Basic Principles of Quality Management Basic Principles of Quality Assurance Basic Requirements of Quality Assurance Basic Principles of GMP Basic ...

http://aseancosmetics.org/presentation/GMP_Quality_Manual_Module.ppt

Date added: May 6, 2013 - Views: 15

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WHO GMP Certification M. Mitra CDSCO(NZ) - Welcome to ...

WHO GMP Certification M. Mitra CDSCO(NZ) WHO GMP CERTIFICATION Originally promugulated in 1969 and revised in 1975. Main objectives were : Guidelines be developed for official inspections of dug manufacturing facilities To assess compliance of GMP This would facilitate implementation of the ...

http://hllaftkcentre.com/resources/MANUFACTURING/WHO%20GMP%20Certification.ppt

Date added: October 30, 2011 - Views: 41

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Quality management - KT

... and their fundamental importance to the production and control of pharmaceutical products Quality Management Principles of Quality ... Operators not only need initial training but also follow-up training. Basic requirements for GMP ... Good Manufacturing Practice (GMP) is the ...

http://ljs94.hosting.paran.com/drugcopia/Qu.ppt

Date added: May 18, 2012 - Views: 66

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GMP & Quality Assurance - UNAND

... Homeopathic medicines GMP Good Manufacturing Practice Good Management Practice Get More Profit Give more Production GMP Training with out tears Ten Principles of GMP Design ... These are Good manufacturing practices Reduction ... Basic Requirements of GMP Why GMP is ...

http://ffarmasi.unand.ac.id/media/download/doc/292/raw

Date added: May 22, 2013 - Views: 35

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COSMETIC GMP - BPFK

GOOD MANUFACTURING PRACTICE is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. Basic GMP Rules Suitable ... of the principles of GMP.

https://www.bpfk.gov.my/quest2/pdfworddownload/GMP%20for%20Cosmetics%20-Cosmetics%20Seminar.ppt

Date added: October 23, 2013 - Views: 22

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ASEAN GMP TEAM FRANCE BENCHMARKING 23 – 29 October 2005

ASEAN GMP TRAINING MODULE ... Individual responsibilities must be clearly understood by individuals concerned All personnel should be aware of the principles of cosmetic GMP that ... Prompt the QC functions, for initiating any investigation and measures. JOB DESCRIPTION EXAMPLE Training, ...

http://www.aseancosmetics.org/presentation/GMP_Personnel_Module.ppt

Date added: November 1, 2011 - Views: 58

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GMP AND cGMP CONSIDERATIONS - Ning

... in Homeopathic medicines GMP Good Manufacturing Practice Good Management Practice Get More Profit Give more Production GMP Training with ... Safety Efficacy Good Manufacturing Practices A basic tenet of GMP is that ... Ten Principles of GMP Design and construct the ...

http://api.ning.com/files/ad8MCcp*e1pf9w2ASnqGab32g80WAwmjkk3BAWWd8ASmsH*q6ksln2PvdhP6QraGHWKSywizkpwayk6oL7yXlUtUk7shGRyp/GMPANDcGMPCONSIDERATIONS.ppt

Date added: October 15, 2011 - Views: 420

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WHO GMP Certification M. Mitra CDSCO(NZ) - PHARMACEUTICALS ...

... Training - induction, ongoing, refresher etc.alonwith such documents like SOP, ... Chennai_12 * Chennai_12 * WHO GMP CERTIFICATION Basic principles of WHO Good Manufacturing Practice is similar to any established GMP requirement. Allied documents like Schedule M, ...

http://pharmexcil.org/uploadfile/ufiles/2057568445_WHO_GMP.ppt

Date added: March 24, 2013 - Views: 49

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Good Manufacturing Practices in the manufacture of medicines

... On completion of the GMP Basic Training Modules, ... IV Basic principles of GMP in more detail 17. dia European Union Directive The Quality Management Quality Management Quality Management Quality Management Quality Management Requirements for QA Systems Quality Management ...

http://www2.pharm.u-szeged.hu/gyfi/minbiz/eng3gmp1.ppt

Date added: August 26, 2013 - Views: 27

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ASEAN GMP GUIDELINE - MOPH

... water must conform to Good Manufacturing Practice It must be “potable” and ... 14-16 Nov 2005 This training module on Water for Cosmetic Manufacturer is a supplement to the series of the ASEAN GMP Training Modules This supplement ... OBJECTIVE BASIC PRINCIPLES WATER ...

http://filing.fda.moph.go.th/library/e-learning/CCD/GMP%20SUPPLEMENTARY%20WATER.ppt

Date added: April 19, 2012 - Views: 79

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GMP Intermediates - Health Care Conference Administrators

... Guiding Principles GMP Training Pyramid HIPAA Privacy and Security Training Basics of Good ... and procedures General More stringent state privacy rules Permissible uses Permissible disclosures Availability Basic March 2003 Intermediate August 2003 GMP for FPP Job/Task ...

http://www.ehcca.com/presentations/HIPAA5/1_07.ppt

Date added: October 8, 2011 - Views: 70

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GxP and cGxP in Pharmaceutical Industry - Ning

For example, cGMP is an acronym for "current Good Manufacturing Practices ... 28 March 2011 Department of Pharmaceutics * Good Manufacturing Practices A basic ... Sterile parenteral for injection Packaging Packaging Packaging Biotechnology Manufacturing Process Ten Principles of GMP ...

http://api.ning.com/files/xwq54lFxZPdZuHr05xYjmLL3EBnANtueyanoUVMShtW08gMCoqyECAVRaIpDsCWOPI2JrNnLLVZLwk8lyEm5TYTvWG68i9Bc/GxPandcGxPinPharmaceuticalIndustry.ppt

Date added: May 27, 2012 - Views: 174

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Introduction to CGMP

An Outline Legal bases for CGMP CGMP legal principles CGMP Implementation Tools CGMP Resources Overview of CGMP Requirements ... This can also include basic ... or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice ...

http://www-naweb.iaea.org/napc/iachem/training-modules/QA_GMP%5CGMP%5Cbuhay2.ppt

Date added: May 22, 2013 - Views: 35

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PARTE II Boas Práticas de Fabricação (GMP)

Managers and supervisors should have enough knowledge of principles of food hygiene ... and responsibilities Training programs Instruction and supervision Refreshing training Minimum program for GMP training courses ... GOOD MANUFACTURING PRACTICE EVALUATION Verification ...

http://www.international-food-safety.com/ppt/gmp.ppt

Date added: September 11, 2011 - Views: 188

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Basic principles of the HACCP system

corr vS 10 9, corr. 13-08 +14-8 +18-4, 17.9. Modul 01 - lecke 04 A HACCP rendszer alapelvei

http://enfo.agt.bme.hu/drupal/sites/default/files/M1L4-a%20rendszer%20alapelvei.ppt

Date added: May 2, 2013 - Views: 21

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Slide 1

... • Describe the basic principles of GMP and how they relate to ... Describe the basic principles of good manufacturing practice and how they relate to ... working in partnership with the NHS and professional bodies to provide high quality e-learning content for the training of the ...

http://www.e-lfh.org.uk/media/121328/Learnbloodtransfusion-The-Essential-Guide-v310_Feb-2014.ppt

Date added: February 28, 2014 - Views: 9

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FDA Auditing of Computerized Systems - Health Care Conference ...

... How Your World is Changing Basic Quality System Purposes and Principles Management ... and Challenges Critical Awareness and Recommendations for Success The Changing World of GMP New quality systems based ... and training Truly affecting day-to-day operations and behavior A ...

http://www.ehcca.com/presentations/fdasymposium/richman_3.ppt

Date added: January 30, 2012 - Views: 30

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GLP Training - Amazon S3

GLP Training Daniel W ... GLP compliance statement Takes Responsibility for GLP compliance Terms to Know GLP Good Laboratory Practice GMP Good Manufacturing Practice GCP Good Clinical Practice Terms to Know Protocol A document which ... Research Misconduct Basic GLP Principles ...

http://s3.amazonaws.com/engrade-myfiles/4063784427759327/GLP_new_hire.ppt

Date added: March 3, 2012 - Views: 114

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Good Clinical Practice GCP - Kennesaw State University ...

... What is GCP Guidelines for GCP The history of Good Clinical Practices Basic principles Practices and strategy for staying compliant with Good ... and stored in accordance with applicable good manufacturing practice ... Good Clinical Practice Guidelines Good Clinical Practice ...

http://science.kennesaw.edu/~jhendrix/regs/GCP.ppt

Date added: October 30, 2011 - Views: 98

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Company name DEPARTMENT Management of GMP Documentation

Training Objectives. References. ... To provide a high level introduction to the principles of Qualification and Validation for people not working directly with this area. ... Company name DEPARTMENT Management of GMP Documentation

http://inglasia.com/wp-content/uploads/2012/04/003-Qualification-and-Validation-An-Overview1.pptx

Date added: September 7, 2012 - Views: 54

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Prequalification and ADP - World Health Organization

... China, Ukraine) Three GMP training courses (South-Africa, China), GMP training course in Tanzania (with PQ participation) Training of QC lab officials Specific to antimalarial medicines ... resistance Prequalification basic principles Voluntary for participating manufacturers Legitimate ...

http://archives.who.int/tbs/tbs2006/TBS_PQ_2006.ppt

Date added: March 8, 2012 - Views: 42

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Ch 3. The drug manufacturing process - KAIST

... Manufacturing process itself - Training and ... Overview of manufacturing process International Pharmacopoeia Martindale PowerPoint Presentation Guides to Good Manufacturing Practice PowerPoint Presentation Principles outlined in GMP Principles regarding Premises and ...

http://bel.kaist.ac.kr/extfiles/lecture/2012spring/bs233/Manufacturing%20process.ppt

Date added: September 11, 2012 - Views: 54

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PowerPoint Presentation

... On their knowledge Experience in manufacturing and QC principles as well as years of first hand experience dealing with GMP ... Defining Auditor Qualification Two formats Scientific Principles Training ... - Receive Some basic training More exclusive training Highly trained ...

http://parasshah.weebly.com/uploads/9/1/3/5/9135355/quality_audit.ppt.ppt

Date added: August 2, 2013 - Views: 27

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No Slide Title

The training program should be ... Environment Packaging materials Factors contributing to Product Quality FACTORS AFFECTING PRODUCT QUALITY BASIC PRINCIPLES BASIC ... CALIBRATION LABELS CHANGE CONTROL TRAINING PROGRAM REFERENCES ASEAN Guidelines for Cosmetic GMP (2003) WHO EDM, Basic Principle ...

http://www.newenglandscc.org/images/Cosmetic_GMP_Implementation_Part_5.ppt

Date added: June 11, 2012 - Views: 9

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Good Agricultural Practices (GAP) for the Fresh Produce Industry

Introduction Basic Principles Basic Principles, ... Worker Health and Hygiene Training of Workers Must Include The importance of good personal ... Water should be of drinkable quality. Counter flow of water and produce in reuse systems is recommended. Good Manufacturing Practices (GMP) ...

http://www.uark.edu/ua/foodedu/Modules_of_Instruction/GAPIntroduction.pps

Date added: October 9, 2013 - Views: 13

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SECTION 1 1. MANAGEMENT OF MICROBIAL PROCESSES / QUALITY ...

... Principles of GMP Process design / optimisation Economics DEVELOPMENT OF A MICROBIAL ... Chp 8 p124. 1.1 MANAGEMENT AND GOOD MANUFACTURING Good Manufacturing Practice ... A basic tenet of GMP is that quality cannot be tested into a batch of product but must be built ...

http://www.ucd.ie/indmicro/damien/Lecture%201.ppt

Date added: November 22, 2011 - Views: 84

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Prequalification and ADP

... resistance Prequalification basic principles Voluntary for participating manufacturers Legitimate ... China, Ukraine) Three GMP training courses (South-Africa, China) Upcoming GMP training course in Tanzania (with PQ participation) Training of QC lab officials Specific to antimalarial ...

http://archives.who.int/tbs/tbs2007/R%C3%A4go_PQ_2007.ppt

Date added: May 5, 2013 - Views: 7

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Company name DEPARTMENT Management of GMP Documentation

To give an overview of the principles involved in the manufacture of sterile products. ... Training is required for cleaning and disinfection of clean rooms. ... Basic GMP. Fundamentals of microbiology. Personal hygiene, ...

http://inglasia.com/wp-content/uploads/2012/04/004-Sterile-Product-Manufacturing1.pptx

Date added: September 14, 2012 - Views: 49

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Good Manufacturing Practices

Good Manufacturing Practices (GMP) Az előállítási és minőségellenőrzési folyamatok olyan kombinációja, ... The basic document is the Codex text General Principles of ... lecture 01 * HACCP training course; module 03 - lecture 01 GMP * This lecture will highlight some aspects of Good ...

http://enfo.agt.bme.hu/drupal/sites/default/files/M3L1-GMP%20és%20GHP.ppt

Date added: May 4, 2013 - Views: 35

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Clinical Trial Design Principles for Dummies

Thirteen Clinical Trial Design Questions and Answers Peter A. Lachenbruch DB Cynthia Rask DCEPT

https://fda.nihtraining.com/docs/4Clinical%20Trial%20Design.ppt

Date added: September 7, 2014 - Views: 1

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Presentazione di PowerPoint - Apotekarsocieteten

... should comply with the basic requirements of the Part II while manufacture of medicinal gases should comply with the basic requirements of Part I. GMP ... in line with the principles of good manufacturing practice and specific to ... and training, sanitation, cleanliness ...

http://www.swepharm.se/upload/Revision%20av%20Eudralex%20vol%204.ppt

Date added: May 29, 2012 - Views: 86

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Good Manufacturing Practices - أبعاد قيادية

Good Manufacturing PracticesGMPممارسات التصنيع ... Although there are a number of them, all guidelines follow a few basic principles: ... GMP basic requirements . 3.

http://leadershipdimensions.org/uploads/pptfilesforld/GMP-P2-General.pptx

Date added: May 4, 2013 - Views: 36

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OPS AC mtg October 5&6 - Food and Drug Administration

It specifically provides guidance on the principles ... The Q documents are a part of the knowledge. Establishing new knowledge Combining basic ... Validation Q3 Impurities Q4 Pharmacopoeias Q5 Quality of Biotechnological Products Q6 Specifications Q7 Good Manufacturing Practice Q8 ...

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241OPH1_02.ppt

Date added: October 15, 2011 - Views: 52

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Validation - cGALP

Good Manufacturing Practices Validation ... information on the Validation Master Plan Validation Validation Introduction Three basic principles of Quality ... Modules on GMP expands on the subject of VALIDATION that was introduced to you in WHO Basic Training Module 4. It ...

http://www.cgalp.com/documents/Validation01.pps

Date added: May 2, 2013 - Views: 35

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Good Clinical Practice in Research

The reason for this training is to …. Historical Backdrop leading to GCP Guidelines. Key Developments & Landmark Documents. ... Most horrendous example of disregard for basic ethical principles in research. $10 million paid out in settlements; formal apology in late 1990s by President Clinton.

http://www.med.navy.mil/sites/NMCP2/EduTrain/CID/Documents/07%20Good%20Clinical%20Practice.pptx

Date added: November 21, 2013 - Views: 1

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GMP Updated Training Modules

Good Manufacturing Practice Water for ... Water requirements and uses general principles for pharmaceutical water systems water quality specifications application of specific types of water to ... GMP Updated Training Modules Subject: Basic Prinicples of GMP Author: loconte ...

http://digicollection.org/whoqapharm/documents/s20078en/s20078en.ppt

Date added: September 7, 2014 - Views: 1

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Improving Good Pharmaceutical Practices “Moving from an SOP ...

All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, ... 2.4.2 Beside the basic training on the theory and practice of Good Manufacturing Practice, ...

http://www.sapraa.org.za/presentations/Jun2009/Q10CS.ppt

Date added: October 15, 2011 - Views: 281

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Introduction to Water Treatment - Надлежащая ...

Good Manufacturing Practice Water for Pharmaceutical Use ... untreated raw water Pre-treatment of water Principles (1) ... This training module on Water for Pharmaceutical Use is a supplement to the series of the WHO Basic Training Modules on GMP, ...

http://www.gmpua.com/Service/WATER/WHO/Water01.ppt

Date added: November 5, 2011 - Views: 101

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What’s New in the FDA’s Pharmaceutical Inspectorate and ...

... New hire Investigators Training completed in first 12 months Demonstrate competency via audit of results Level I Training Web Based Classroom Basic Food and Drug Law ... concepts and principles Principles for ... and training in pharmaceutical ...

http://asq.org/fdc/events/ppt/200604-golden-gate-section-conference.ppt

Date added: September 11, 2012 - Views: 25