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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: 581

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

Date added: November 1, 2011 - Views: 186

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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: 26

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Basic Principles of GMP

... Qualifications and Training ... MS Arial SimSun Wingdings Copy of Module9prem modified db part 2 Microsoft Word Document Microsoft Clip Gallery Basic Principles of GMP Documentation Documentation Slide 4 Slide 5 Documentation Documentation Documentation Documentation ...

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

Date added: May 16, 2013 - Views: 26

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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: 102

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

ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM Manufacturer ... OF PRESENTATION Basic 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: 65

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temp.ppt - FUTURE BEACON

... On completion of the GMP Basic Training Modules, ... 10 minutes for each group to make its presentation. At the end of each of the modules on Basic Principles of GMP (except ... I want to prepare two GMP training modules for use in my own country by the year 2003. Show how this is ...

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

Date added: June 15, 2013 - Views: 20

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ASEAN GMP TEAM FRANCE BENCHMARKING 23 – 29 October 2005

ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT ... Basic 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 Basic Requirements of Quality ...

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

Date added: May 6, 2013 - Views: 12

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ASEAN GMP GUIDELINE

SUPPLEMENTARY ASEAN GMP TRAINING MODULE EQUIPMENT ... Chemical disinfection methods SANITATION PRINCIPLES * CLONCLUSION Proper cleaning and sanitation process of each equipment can avoid : 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: 91

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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 ... are Good manufacturing practices Reduction ... Principles of Quality Assurance (QA) BASIC ...

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

Date added: May 22, 2013 - Views: 31

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

... To assess compliance of GMP This would facilitate implementation of the scheme WHO GMP CERTIFICATION Basic principles of WHO Good Manufacturing Practice is similar to ... Role, Functions & Training GMP ... implementation of the scheme WHO GMP CERTIFICATION Basic principles of WHO Good ...

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

Date added: October 30, 2011 - Views: 37

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Quality management - KT

... and their fundamental importance to the production and control of pharmaceutical products Quality Management Principles of Quality Assurance Wide-ranging concept ... follow-up training. Basic requirements for GMP are as follows: 6 ... is part of good manufacturing practice.

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

Date added: May 18, 2012 - Views: 62

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

WHO GMP Certification Scheme M. Mitra Former Dy. Drugs Controller (I), CDSCO, HQ, New Delhi * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Chennai_12 * Chennai_12 * Chennai_12 * WHO GMP CERTIFICATION Inspection Points 1.

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

Date added: March 24, 2013 - Views: 44

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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 ... Mal Cosmetic GMP Ear/Sha ...

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

Date added: October 23, 2013 - Views: 17

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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: 53

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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: 23

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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: 408

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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: 70

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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: 30

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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: 167

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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: 65

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PARTE II Boas Práticas de Fabricação (GMP)

Managers and supervisors should have enough knowledge of principles of food hygiene DOCUMENTATION ... 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: 184

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Basic principles of the HACCP system

... hogy ellenőrzés alatt áll (szabályozott) A Good Manufacturing Practice (GMP) és a ... Kritikus Szabályozási Pont Forrás Kritikus határérték Habképződés Vizsgálat Habzás megfigyelése HACCP training course; module 01 ... Basic principles of the HACCP system ...

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

Date added: May 2, 2013 - Views: 19

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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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Company name DEPARTMENT Management of GMP Documentation

To provide a high level introduction to the principles of Qualification and Validation for people not working directly with this area. ... References EU GMP volume 4. ... Basic Checking of Validation Documentation (5)

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

Date added: September 7, 2012 - Views: 49

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

... How Your World is Changing Basic Quality System Purposes and Principles Management ... The Changing World of GMP New quality systems based framework ... Responsibility The cornerstone of quality systems and FDA’s approach Management cannot delegate its ...

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

Date added: January 30, 2012 - Views: 28

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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 Clinical Practices. ... training, and experience to ... and stored in accordance with applicable good manufacturing practice ...

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

Date added: October 30, 2011 - Views: 93

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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: 109

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Ch 3. The drug manufacturing process - KAIST

... in-process product, air etc..) A basic feature of ... 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: 49

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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: 33

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PowerPoint Presentation

Defining Auditor Qualification Two formats Scientific Principles Training ... Objectives Difference between Quality audit and Periodic evaluation Self inspection Types of Quality Audit Role OF GMP Audit in QA and QC ... Returned and Salvaged drug The basic elements are derived ...

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

Date added: August 2, 2013 - Views: 26

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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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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: 40

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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: 11

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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: 78

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AFDO Retail Risk Assessment - MCAFDO

... Risk perception Varies Basic Principles ... FDA Seafood HACCP 9 CFR 417.7 for USDA/FSIS HACCP Course of instruction in the application of the seven HACCP principles HACCP Training How Know your audience Expected knowledge ... Programs such as Good Manufacturing Practices, ...

http://www.mcafdo.org/training/presentations/Osborne_AFDO%20Retail%20Risk%20Assessment.ppt

Date added: August 25, 2011 - Views: 119

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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: 33

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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: 5

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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: 32

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Validation - current Good Analytical Laboratory Practices (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: 31

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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: 80

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

It specifically provides guidance on the principles and some of the tools of ... Specifications Q7 Good Manufacturing Practice Q8 Pharmaceutical Development Q9 Quality ... Integrated quality management Documentation Training and education Quality defects Auditing ...

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

Date added: October 15, 2011 - Views: 52

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ASQ Certifications: The Exam Development Process

... (once) 3.0 RUs Company-sponsored training 4.0 RUs (e.g., project ... CQIA Korean - CRE, CQE Portuguese - CQE * What is certification? What are benefits of certification? Certification history ... A professional who understands the GMP principles as regulated and guided by ...

http://www.asq0511.org/Presentations/201203/ASQ0511-201203ASQCertificationTheBasicsandBenefits.ppt

Date added: September 15, 2012 - Views: 21

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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: 99

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Metal Detection - The Basics

... The Basic Principles 1.1 Theory of Operation 1.2 Product Effect and Phasing 1.3 ... (tri-clamp, I-line etc) Product flow rate (GMP) Product viscosity Product temperature ... Prevention 1.1 Training 1.2 Controlled Maintenance 1.3 Regular Inspection & Good ...

http://public.web-il.net/tmi-barak/files/Metal%20Detection-The%20Basics%20(Slide).ppt

Date added: February 11, 2012 - Views: 35

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Biosafety At the University of Ottawa - Sandia National ...

... (GMP) Basic code of practice that should be applied to all types of work involving microorganisms. ... BIOMEDICAL WASTE DECONTAMINATION, DISINFECTION, AND STERILIZATION Decontamination: Free of contamination, ... Special Animal Care training is required for all personnel working with animals.

http://biosecurity.sandia.gov/ibtr/subpages/pastConf/20102011/afghan/Day%20One/BiosafetyPrinciples.ppt

Date added: March 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: 272

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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

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No Slide Title

EU Commission Directives Legislative EU Guide to Good Manufacturing Practice Help in the interpretation of the legislation European legislation is ... (QP and GMP Law) 2003/94/EC Principles of GMP EU - EudraLex - Volume 4 GMP ... FDA Basic Inspection Techniques - similar to EMEA ...

http://eleceng.dit.ie/gavin/DT275/cppt9010/Lecture%203%20Part%201.ppt

Date added: May 9, 2013 - Views: 18