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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: 577

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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: 182

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Basic Principles of GMP - World Health Organization

Title: Basic Principles of GMP Author: David Richard Buckley Last modified by: Alexander Polishchuk Created Date: 3/17/2000 11:39:01 AM Document presentation format

http://www.who.int/prequal/trainingresources/pq_pres/workshop_Russia/M02-QA-doc-1-f_U.PPT

Date added: May 14, 2013 - Views: 15

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Basic Principles of GMP - u-szeged.hu

Basic Principles of GMP Documentation * * The batch packaging record is required for every batch or part batch that is packaged. It is developed from the relevant part of the packaging instructions and, once again, its review is an important part of the batch release process.

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

Date added: August 27, 2013 - Views: 19

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Basic Principles of GMP

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: 24

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temp.ppt - FUTURE BEACON

... I Basic Principles of GMP 1. Introduction to the training programme 2. ... On completion of the GMP Basic Training Modules, we shall distribute a Personal Action Plan form in order to check your understanding of the materials, ...

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

Date added: June 15, 2013 - Views: 16

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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: 100

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

ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM Manufacturer ... 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 ...

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

Date added: June 10, 2012 - Views: 61

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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: 35

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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: 28

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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: 23

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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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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: 18

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Quality management - 모바일 궁

Basic Principles of GMP ... Operators not only need initial training but also follow-up training. Basic requirements for GMP are as follows: 6. Complete records document the manufacturing process. ... Good Manufacturing Practice (GMP) ...

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

Date added: May 18, 2012 - Views: 59

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ASEAN GMP TEAM FRANCE BENCHMARKING 23 – 29 October 2005

ASEAN GMP TRAINING MODULE PERSONNEL Prepared by Rosni ... Individual responsibilities must be clearly understood by individuals concerned All personnel should be aware of the principles of cosmetic GMP that affect them and continuing training ... (2003) WHO - EDM, Basic Principle of GMP: ...

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

Date added: November 1, 2011 - Views: 52

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ASEAN GMP TEAM FRANCE BENCHMARKING 23 – 29 October 2005

... Basic Principles of Quality Management Basic Principles of Quality Assurance Basic Requirements of Quality Assurance Basic Principles of GMP ... Lucida Sans Unicode Comic Sans MS Verdana Ref Default Design Microsoft Photo Editor 3.0 Photo Bitmap Image ASEAN GMP TRAINING ...

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

Date added: May 6, 2013 - Views: 12

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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: 17

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

... Training - induction, ... Chennai_12 * Chennai_12 * WHO GMP CERTIFICATION Basic principles of WHO Good Manufacturing Practice is similar to any established GMP requirement. ... Salient features Good Practices for National Control Laboratories Basic elements of GMP ...

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

Date added: March 24, 2013 - Views: 41

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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 ... Ten Principles of GMP Design and construct the facilities ... Safety Efficacy Good Manufacturing Practices A basic tenet of GMP is that ...

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

Date added: October 15, 2011 - Views: 398

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ASEAN GMP GUIDELINE - MOPH

GMP SUPPLEMENTARY TRAINING MODULE WATER FOR COSMETIC USED Prepared by : ... The principles are contained in the Good Manufacturing Practices: ... OBJECTIVE BASIC PRINCIPLES WATER TYPE WATER CONTAMINANTS WATER CONTAMINANTS (1) ...

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

Date added: April 19, 2012 - Views: 65

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Introduction to CGMP

Training Program cGMP in ... Office of Compliance, CDER, FDA An Outline Legal bases for CGMP CGMP legal principles CGMP Implementation Tools CGMP Resources Overview ... (misbranded Reason for CGMP C in CGMP Introduction to Drug Current Good Manufacturing Practice Of US FDA “A drug ...

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

Date added: May 22, 2013 - Views: 29

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PARTE II Boas Práticas de Fabricação (GMP)

GOOD MANUFACTURING PRACTICES ... GMP Prerequisite programs which will provide the basic environmental and operating conditions that are ... and responsibilities Training programs Instruction and supervision Refreshing training Minimum program for GMP training courses Code of ...

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

Date added: September 11, 2011 - Views: 176

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GxP and cGxP in Pharmaceutical Industry - Ning

For example, cGMP is an acronym for "current Good Manufacturing Practices." cGMP is ... Good Manufacturing Practices A basic tenet of GMP is that quality cannot be ... 28 March 2011 Ten Principles of GMP Design and construct the facilities and equipments ...

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

Date added: May 27, 2012 - Views: 162

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Basic principles of the HACCP system - BME

... 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: 17

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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: 7

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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: 61

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

... and training Truly affecting ... How Your World is Changing Basic Quality System Purposes and Principles ... System “Quality” and “Compliance” “Quality” and “Compliance” Underlying Principles Underlying Principles Underlying Principles GMP and the U.S ...

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

Date added: January 30, 2012 - Views: 27

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Company name DEPARTMENT Management of GMP Documentation

Basic Checking of Validation Documentation. Revalidation. ... Training Objectives. 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.

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

Date added: September 7, 2012 - Views: 47

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Ch 3. The drug manufacturing process - KAIST

... Training and commitment of ... to which the final product is produced Standard processes and guides to good manufacturing practice ... 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: 47

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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: 90

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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: 31

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PowerPoint Presentation

Defining Auditor Qualification Two formats Scientific Principles Training under chemistry, ... statistical and pharmaceutics GMP GMP training may include the cumulative knowledge from years of ... Returned and Salvaged drug The basic elements are derived from the following subpart of ...

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

Date added: August 2, 2013 - Views: 23

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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 hygiene. ... (GMP) found in 21 CFR 110 for water quality are strongly recommended even though not required for produce operations.

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

Date added: October 9, 2013 - Views: 7

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Company name DEPARTMENT Management of GMP Documentation

Training is required for cleaning and disinfection of clean rooms. ... Basic GMP. Fundamentals of microbiology. Personal hygiene, ... Personnel in the aseptic manufacturing area, must understand the principles of aseptic procedures.

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

Date added: September 14, 2012 - Views: 38

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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: 74

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GLP Training - Amazon S3

... 2000 Basic GLP Principles Study ... Use of pest control materials shall be documented Maintain a current summary of training ... GLP compliance statement Takes Responsibility for GLP compliance Terms to Know GLP Good Laboratory Practice GMP Good Manufacturing Practice GCP Good ...

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

Date added: March 3, 2012 - Views: 106

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Validation - cGALP

Good Manufacturing Practices ... information on the Validation Master Plan Validation Validation Introduction Three basic principles of Quality Assurance ... 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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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: 117

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Biuro turystyczne TRIADA - uniag.sk

... if depends on permanent training of the employees to ... and have created their own GMP guidelines that correspond with their legislation GMP basic principles: ... Good Manufacturing Practice GMP basic principles: CE marking CE mark CE marking CE marking CE marking Organic ...

http://spu.fem.uniag.sk/Elena.Horska/ceb/Standarisation_and_Certification_of_the_European_Market.ppt

Date added: February 15, 2014 - Views: 5

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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: 4

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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: 31

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68Ge/68Ga-Generator: GMP vs. non GMP, why it is necessary to ...

They are a series of general principles that must be fulfilled or observed ... Berlin, Germany Good Manufacturing Practices Part II: Basic Requirements for Active Substances used as ... Where is it described? Good Manufacturing Practices GMP Regulations for Radiopharmaceuticals Terms and ...

http://asiannmschool.org/downloads_trainnig/03%20Good_Manufacturing_Practices_in_Radiopharmaceutical_Production.pps

Date added: January 27, 2012 - Views: 83

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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 ... will meet internationally accepted good manufacturing practice principles ... and training, sanitation, cleanliness ...

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

Date added: May 29, 2012 - Views: 71

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

The basic requirements of GMP are that: (i) ... 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: 265

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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 Evidence ... Approval Changes GMP ... risk concepts and principles Principles for implementation Elements of ...

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

Date added: September 11, 2012 - Views: 25

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ASQ Certifications: The Exam Development Process

Full-time employment 10.8 RUs AQC attendance (once) 3.0 RUs Company-sponsored training 4.0 RUs (e.g ., project management, Diversity in the ... Basic knowledge of quality tools and ... A professional who understands the GMP principles as regulated and guided by national and ...

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

Date added: September 15, 2012 - Views: 20

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Good Manufacturing Practices - أبعاد قيادية

Good Manufacturing Practice is a set of regulations, codes, ... Although there are a number of them, all guidelines follow a few basic principles: ... premises and equipment to the training and personal hygiene of staff.

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

Date added: May 4, 2013 - Views: 32

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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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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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Diapositive 1 - Global Food Safety Initiative

Good Manufacturing Practices. Personal Hygiene. Facility Environment. ... General Principles of Food Hygiene. Hazard Analysis and Critical Control Points System. ... Training. GMP. Facility and Equipment Maintenance. Staff Facilities.

http://www.mygfsi.com/gfsifiles/GFSI_Global_Markets_Manufacturing_Presentation_-_FINAL_-_August_2011.pptx

Date added: May 5, 2013 - Views: 13