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Document Index - Quality Engineering, Validation and ...

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Document Index - Quality Engineering, Validation and ...

Quality Documents for the Pharmaceutical Manufacturing. Templates. Title: Quality Manual Template. Abstract: ISO standards and FDA require that a manufacturing entity has a Quality Manual in place. This is required before a INDA or PMA is submitted.

http://www.qualityleader.com/Document%20Index%20with%20index-%20beta1.doc

Date added: October 18, 2011 - Views: 369

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2-1- Purpose - Elsmar

2-1- Purpose. This document defines quality system policies and procedures for governing the design & manufacture of all Sobhan Chemotherapeutical Co. products.

http://elsmar.com/pdf_files/Quality%20and%20Other%20Manuals/Quality%20Manual%20En.doc

Date added: October 23, 2012 - Views: 21

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Section 1 Quality Manual

QUALITY POLICY. The quality manual defines the organisation and management requirements of Hygiene in relation to the company quality management system (QMS).

http://hygienemanuals.co.uk/manuals/quality/2000%20QM-1.doc

Date added: September 18, 2014 - Views: 1

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ANSI/NSF 4 B 2000 - NSF International: Welcome

NSF Draft Standard for. Pharmaceutical Excipients – Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. 1 General. 1.1 Introduction. The principles outlined in this Standard provide a comprehensive basis for the quality management system used in the manufacture of pharmaceutical ...

http://standards.nsf.org/apps/group_public/download.php/16070/363i1r1e.doc

Date added: May 19, 2012 - Views: 46

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IPEC GDP for Excipients

IPEC Good Distribution Practices Audit Questionnaire for Pharmaceutical Excipients. This document has been written to provide a tool for those auditing companies involved in the supply chain of pharmaceutical excipients.

http://ipec-europe.org/UPLOADS/IPEC_GDP_Audit_Guide_Final(1).doc

Date added: October 12, 2014 - Views: 1

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Section 4 - Testmetric

The quality manual is controlled according to Procedure 423 Control of Documents Procedure. ... Industries served include Pharmaceutical, Aerospace, Manufacturing, Educational and Utility Field. The Facility is located as follow: Testmetric . 605C Cité des Jeunes, St-Lazare, Qc, J7T 2A7.

http://www.testmetric.com/images/Quality_Manual2.doc

Date added: May 2, 2013 - Views: 27

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Compliance Policy Guide - Food and Drug Administration

electronic records, and product quality, apply to pharmaceutical manufacturers, repackagers, relabelers, distributors, retailers, or others who participate in feasibility studies and pilot programs (collectively "a study" or "studies") using Radiofrequency Identification ...

http://www.fda.gov/downloads/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/UCM246448.doc

Date added: May 11, 2012 - Views: 32

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Operational Policy and Procedure Manual About the Manual

This manual has been divided into thirty-nine (39) ... Administrative Services Pharmaceutical Services. Admissions Physician Services. ... • Policies and procedures that govern the facility’s development and implementation of a quality assessment and assurance program;

http://mail.scmcf.org/Policy%20&%20Procedures/Heaton%20Manual%20Policy%20and%20Procedure/Heaton%202009/PandP%20Word%20Files/OPPM%20Volume1/07-AboutManual/002-AboutManual.doc

Date added: November 1, 2013 - Views: 21

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Excipient Audit Guideline - IPEC Europe

Pharmaceutical Excipients. I. Purpose and Scope. In the pharmaceutical industry it is the responsibility of the drug product manufacturer to ensure the quality of all starting materials and other components contained in or used in the manufacture of the final product dosage form.

http://ipec-europe.org/UPLOADS/IPEC_GMP_Audit-Systems_2008_Final_Printing_(3)(1).doc

Date added: October 13, 2014 - Views: 1

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4 - NSF International

4 Quality Management System Introduction. The principles outlined provide a comprehensive basis for the quality management system used in the manufacture of pharmaceutical excipients.

http://standards.nsf.org/apps/group_public/download.php/8184/GMP_Quality_System_Standard_5-4-2010%20IS.doc

Date added: February 27, 2014 - Views: 21

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Quality Manual - NHS Joint Research

Quality Manual. The collection, storage and use of tissue in research in accordance with Newcastle University’s research sector Human Tissue Act Licence (No. 12534)

http://www.newcastlejro.org.uk/wp-content/uploads/2012/04/Quality-Manual_Mhairi_E02.docx

Date added: March 7, 2014 - Views: 2

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行政院衛生署 - FDA

Name of Pharmaceutical Firm: (Chinese) Address of Pharmaceutical Firm: (Chinese) ... 3.10 Has the original manufacturer provided the most up-to-date and valid version of quality manual, document list, and quality system procedures in this application?

http://www.fda.gov.tw/upload/133/Content/2013103011214320875.doc

Date added: December 7, 2013 - Views: 17

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SUPPLIER QUALITY EVALUATION QUESTIONNAIRE - objectives

1.4 Who is responsible for the final product release? 1.5. Who is responsible for contacts with us concerning quality matters ... aware that the products supplied are used for the manufacturing of active pharmaceutical ... 9.21 Does your carrier have a Quality Manual?

http://www.apic.cefic.org/pub/Supplier%20Questionnare%20-%20Section%20E%20%20Quality%20Q._modified.doc

Date added: February 10, 2012 - Views: 35

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February 19, 1997_DRAFT

Manual . for Chemical and Pharmaceutical Processing. and Manufacturing Industries. July 1997. State of New Jersey. Department of Environmental Protection. Air Quality Permitting Program State of the Art (SOTA) Manual for Chemical and Pharmaceutical Processing. and Manufacturing Industries ...

http://www.nj.gov/dep/aqpp/downloads/sota/sota5.doc

Date added: October 13, 2012 - Views: 3

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Pharmaceutical Engineering Guide for New and Renovated Facilities

Background. The design, construction, validation (commissioning and qualification) of water and steam systems for the pharmaceutical industry represent key opportunities for manufacturers, engineering proffesionals, and equipment suppliers.

http://www.socalwatertreatment.com/pdfs/ISPE%20baseline%20guide%20volume%204.docx

Date added: March 1, 2014 - Views: 30

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Quality Systems Policy Manual

Title of assignment: Quality Manual . I have read the feedback on my previous assignments in this unit/program and tried to take it into account in writing this assignment. Yes. Y; Not applicable, this is my first assignment in this discipline; No. Reason ...

http://memberfiles.freewebs.com/01/33/44143301/documents/final%20GLP%20assign.docx

Date added: April 26, 2012 - Views: 12

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Auditing Guide - objectives

Is there a Quality Manual or equivalent documentation that describes in detail how the Quality System is implemented? ... Production of highly toxic, non-pharmaceutical products, for example pesticides excluded from pharmaceutical production facilities? 4.5.

http://apic.cefic.org/pub/Auditing/Auditing_Annex2_AideMemoire.docx

Date added: September 15, 2013 - Views: 20

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Comparison of paragraphs, as found in IPEC Draft GDP ...

4.2.2 Quality Manual. ... There shall be no upgrading (relabeling) technical or industrial grade material to pharmaceutical grade quality only on the basis of analytical results found in conformance with the requirements of a pharmacopoeial monograph.

http://pqg.org/download-files/GDP%20Annex%20to%20ISO%209001%20draft%2020091222%20for%20review.doc

Date added: November 1, 2011 - Views: 21

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Auditing of Quality Systems of Medical Device Manufacturers ...

Title: Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements Subject: GHTF Last modified by: Mason, Jenny Created Date

http://www.imdrf.org/docs/ghtf/final/sg4/technical-docs/ghtf-sg4-99-28-guidelines-auditing-device-manufacturer-quality-systems-part-one-990629.doc

Date added: April 2, 2013 - Views: 17

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SCADA User Requirements Specification Template

... Guide available through the International Society for Pharmaceutical Engineering (ISPE). ... favoring a high level of manual process interaction by operating personnel, ... Internal quality procedures shall be available for the User’s review.

http://www.ispe.org/jett/scada-urs.doc

Date added: February 23, 2012 - Views: 279

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Manager - QA Audits – Philadelphia, PA

URL Pharma is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities.

http://www.southjerseyasq.org/J103011.doc

Date added: May 10, 2013 - Views: 2

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PHARMACEUTICAL CGMPS FOR THE 21ST CENTURY —

This quality systems model, now incorporated into the FDA Staff Manual Guide, Quality Systems Framework for Internal Activities, ... It is crucial that pharmaceutical quality standards or requirements be harmonized internationally to the fullest extent possible.

http://www.mgdservices.com/pharmaceutical%20CGMPs%20for%20the%2021st%20century.doc

Date added: October 31, 2011 - Views: 44

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For ENAS use only - ESMA

4 B - pharmaceutical testing . Part 5 - About your quality system All new applicants . ... Yes No Quality Manual reference/other comment 1. Is a copy of the Quality Manual supplied with this application? If "No" give reason 2.

http://www.esma.gov.ae/SiteCollectionDocuments/ENAS/Application.doc

Date added: March 14, 2012 - Views: 15

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GUIDANCE DOCUMENT:

GUIDELINES ON INSPECTIONS INVOLVING THE GMP INSPECTORS This document has been prepared to serve as guidance about the GMP Inspectorate responsible for performing inspections for compliance with current Good Manufacturing Principles asserted to by Pharmaceutical Medicine Manufacturers as ...

http://mccza.com/genericDocuments/4.09_Inspections_involving_GMP_inspectors.doc

Date added: October 20, 2011 - Views: 90

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eGov Screen Shots for Setup Utility - Mass.Gov

User Manual for Licensees. This document displays screen shots and describes what a licensee should do to create an account and login using the Massachusetts Department of Public Health Online Licensing site.

http://www.mass.gov/eohhs/docs/dph/quality/healthcare/pharm-manufacturers-licensing-account-creation.doc

Date added: May 18, 2013 - Views: 3

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Scheme of Instruction and Evaluation for M

Quality assurance of pharmaceutical (A compendium of guidelines and selected materials) Vol. I & II, WHO, Geneva, Pharma book syndicate, ... ASQC Quality Press, Milwaukee, 2005. Manual on drugs and cosmetics, 2nd ed., Commercial law publishers (India) Pvt. Ltd., Delhi, 2004.

http://www.ssrcp.com/downloads/syllabus/M-Pharm-Pharm-Analysis.doc

Date added: May 3, 2013 - Views: 97

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Supplier Approval

Supplier Approval And Review. Additionally, ... The Quality Manager shall ensure that all approved suppliers lists are maintained and that all suppliers of goods or services are assessed regularly as to their competency to supply.

http://home.btconnect.com/Briarcare/QMS/Quality%20Procedures/156%20OP%20Manual%20Section%204.9.1supplier%20approval%20%20review%20-%20rev2.doc

Date added: November 11, 2011 - Views: 16

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Dental Hygienist Online Renewal - Mass.Gov

Manufacturer Registration Renewal Manual. This document displays screen shots and describes what a Pharmaceutical or Medical Device Manufacturer should do to renew its registration online.

http://www.mass.gov/eohhs/docs/dph/quality/healthcare/pharm-manufacturers-license-renewal.doc

Date added: October 2, 2012 - Views: 4

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www.pharmaceuticalconferences.com

Encyclopedia of Bioanalytical Methods for Bioavailability and Bioequivalence Studies of Pharmaceuticals ... bank, Rxlist, MEDLINE plus, KEGG Drug ID, KEGG Compound ID, Merck manual, PubChem ... bioanalytical methods for pharmaceutical analysis or regular quality control are also ...

http://www.pharmaceuticalconferences.com/gmp-gcp-quality-control-2014/template.docx

Date added: September 23, 2013 - Views: 1

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MSL936001A Maintain quality system and continuous improvement ...

The laboratory supervisor with a pharmaceutical company had participated in the production of a company wide quality manual. This manual was distributed to the various work teams and an induction program for all workers was undertaken to familiarise them with the demands of the quality system.

http://training.gov.au/TrainingComponentFiles/MSL09/MSL936001A_R1.docm

Date added: August 2, 2013 - Views: 11

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Policies and Procedures for ACPE Criteria for Quality and ...

A copy of the Policy and Procedure Manual related to Operation of the Division shall be maintained in the office of the DCPE and available for inspection of all ... The Division of Continuing Pharmaceutical ... Policies and Procedures for ACPE Criteria for Quality and Interpretive ...

http://www.temple.edu/pharmacy/documents/Handbook_of_CPE_Policies_and_Procedures.docx

Date added: September 27, 2013 - Views: 4

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Accreditation Application - Accredited Labs

... 7F” section C). It is preferable that the Attachments and Quality Manual be submitted as “text searchable” documents. ... Pharmaceutical Testing Fields of Testing (FoT) Technology sub-type/ Detector List In-House Laboratory Method Number (e.g., ...

http://www.aihaaccreditedlabs.org/programfees-guidelines-forms/Documents/LAP%20LLC_Checklist_Accreditation_Application_R10%20%28effective%20June%2021%2c%202013%29%20FINAL.doc

Date added: July 10, 2013 - Views: 37

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Audit Report with GMP Questionnaire - TLI Development

Quality Manual 14. 5.3. SOP System 14. 5.4. Site Master File (SMF) 14. 5.5. Validation Master Plan (VMP) 14. ... Handling and storage of these highly toxic non-pharmaceutical materials should be separate from APIs. Is this in compliance? ( ( ( Lighting.

http://tlidevelopment.com/templates/Audit%20Report%20with%20GMP%20Questionnaire%20(template).doc

Date added: August 1, 2013 - Views: 108

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Pharmacy Operations Manual - Massachusetts General Hospital

Quality. QUA-001 Pharmacy Policy Manual. QUA-002 Documentation Control Procedures. QUA-003 Pharmacy Quality Assurance Program. ... 3.3 Pharmaceutical Calculations. 3.4 USP Chapter 797 Training. 3.5 High-Risk-Level CSP. 3.5.1 Validation. 3.5.2 Challenge Testing.

http://www2.massgeneral.org/pharmacy/QUA-004%20POM%20Table%20of%20Contents.doc

Date added: July 31, 2012 - Views: 86

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For PNAC Use only - Pakistan National Accreditation Council ...

A copy of the laboratory's Quality Manual . A copy of the laboratory's Quality Procedures . A copy of the laboratory's Technical Procedures . ... *Please also mention Active Pharmaceutical Ingredient (API) in case of Pharmaceutical Testing 4C.

http://www.pnac.org.pk/INFOPACK/labsinfopack/F-0101%20Application%20for%20Labs%20Rev%2005.doc

Date added: July 18, 2013 - Views: 4

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State of the Art (SOTA) - New Jersey

2.3 Updating the SOTA Manual. These technical manuals will be reviewed periodically and revised to reflect updated technology, ... 3.5: State of the Art (SOTA) Manual for Chemical and Pharmaceutical Processing and Manufacturing Industries. 3.6: State of the Art ...

http://www.nj.gov/dep/aqpp/downloads/sota/sota0.doc

Date added: February 28, 2013 - Views: 2

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Pharmaceutical Compounding Calculations - KSU

MANUAL FOR. PHARMACEUTICAL TECHNOLOGY. Central Committee . Department of Pharmaceutics ... Students shall spend two days in Quality Assurance where they learn from inspectors and assurance officers how to fill forms to check that all processes in the industry have been carried ...

http://faculty.ksu.edu.sa/hisham/Documents/Students/Lab_Manuals/Lab/pharmaceutical%20technology%20training%20manual-2f.doc

Date added: October 5, 2011 - Views: 83

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Pharmaceutical Manufacturer Inspection Measures

Pharmaceutical manufacturers that shall be inspected in accordance with this set of Regulations are as follows: Firms in the manufacturing, ... Quality manual; Factory registration certificate; Permit license of pharmaceutical manufacturer.

http://140.135.100.101/web/97-project/files/3.200503_Pharmaceutical%20Manufacturer%20Inspection%20Measures.doc

Date added: December 11, 2013 - Views: 12

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SCHEME OF INSTRUCTION AND EVALUATION FOR - Free Website ...

QA manual by D.H.Shah. Basic test for pharmaceutical substances WHO 1988. Elements in biotechnology by P. K. Gupta. ... 11. Quality control tests for pharmaceutical containers. 12. Quality control testing of pharmaceutical containers. 13.

http://memberfiles.freewebs.com/56/49/68654956/documents/PHARM.ANALYSIS.doc

Date added: September 18, 2013 - Views: 46

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Board Responsibilities - Washington State Hospital Association

Pharmaceutical services. Physical rehabilitation services. Radiation oncology services. Respiratory care services. ... A Resource Manual for the Healthcare Quality Professional of the 90s, Austin, TX: The Texas Society for Healthcare Quality, 1993.

http://www.wsha.org/files/62/Gov_Bd_Manual_QUALITY.DOC

Date added: September 25, 2011 - Views: 55

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Comparison of paragraphs, as found in IPEC Draft GDP ...

4.2.2 Quality manual. ... Where critical to pharmaceutical or nutraceutical quality, the organization shall establish an appropriate monitoring programme to show the consistent operation of the excipient manufacturing process.

http://www.pqg.org/download-files/CertifiableAnnextoISO9001for%20Comment.doc

Date added: April 22, 2014 - Views: 2

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ELEMENTS FOR THE CONTROL OF PHARMACEUTICAL PRODUCTS ...

ELEMENTS FOR THE CONTROL OF PHARMACEUTICAL PRODUCTS CONTAINING NARCOTICS AND PSYCHOACTIVE SUBSTANCES . ... -Quantity used in quality control-Quantity of material recovered during production ( i.e., ... Manufacturing records should be maintained in either manual hard copy or electronic form, ...

http://www.cicad.oas.org/Reduccion_Oferta/ENG/Resources/Pharmaceuticals/Fin_report_Feb_04.doc

Date added: February 24, 2012 - Views: 3

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For ENAS use only

A copy of the laboratory's Quality Manual A copy of the laboratory's procedures . ... pharmaceutical testing . Part 5 - About your quality system All new applicants . Part 6 - Other approvals All new applicants .

http://www.esma.gov.ae/SiteCollectionDocuments/ENAS/AF5.dotx

Date added: May 10, 2013 - Views: 2

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FDF20211 Certificate II in Pharmaceutical Manufacturing

Job Roles The Certificate II in Pharmaceutical Manufacturing targets those working within production or production support roles, ... Record basic information on the quality and other indicators of work outcomes. ... Use manual handling technologies in the workplace.

http://training.gov.au/TrainingComponentFiles/FDF10/FDF20211_R2.docm

Date added: December 21, 2013 - Views: 5

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Glossary Pharmaceutical - سایت دارويی دکتر ...

Added to Pharmaceutical Glossary. Quality Plan: A plan created by the supplier to define actions, ... The process of exercising or evaluating a system or system component by manual or automated means to verify that it satisfies specified requirements or to identify differences between expected ...

http://www.drannabi.com/pharmacy/s.d/Glossary%20Pharmaceutical.doc

Date added: October 19, 2011 - Views: 25

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HVAC Design for Pharmaceutical Facilities Course No: M05-006 ...

HVAC Design for . Pharmaceutical Facilities . In pharmaceutical manufacturing, how space conditions impact the product being made is of primary importance.

http://www.mafna.com/ShowNewsLetter.ashx?letterID=9

Date added: August 16, 2013 - Views: 15

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PHARMACEUTICAL INSPECTION CONVENTION

... “Guide to Good Manufacturing Practice for Medicinal Products”, version PE 009-2 dated 1 July 2004 published by the Pharmaceutical Inspection Cooperation Scheme ... Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide.

http://mccza.com/genericDocuments/4.01_SA_Guide_to_GMP_Jun10_v5.doc

Date added: September 9, 2011 - Views: 69

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M.Pharm - RGUHS

Pharmaceutical Quality Assurance by Manohar A. Potdhar, 2nd edition, Nirali Prakashan. ... GLP Quality Audit Manual, Milton A. Anderson, Third Edition, Informa Healthcare. Laboratory Auditing for Quality and Regulatory Compliance, ...

http://www.rguhs.ac.in/Authoritysection/Notifications2013-14/MPharm/15_M.%20Ph%20Drugs%20Regulatory%20Affairs.doc

Date added: August 19, 2013 - Views: 96

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POSITION SUMMARY

Maintains the Quality Manual. Directs the training program to support CGMP/ISO activities in laboratory operations. ... a B.S. degree in Chemistry or related field with 10+ years of relevant industrial experience in a QA setting in Pharmaceutical or Medical Device Company.

http://gpa-cro.com/wp-content/uploads/2014/03/Manager-Quality-Assurance-03-19-2014TH-Edits.docx

Date added: July 3, 2014 - Views: 3

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Table of Contents

This item writing manual is to be used as a guide by the SME item writers. ... The award of the CPIP credential signifies recognition of “change agents” capable of fostering innovation and quality enhancements for the pharmaceutical and biotechnology industries.

http://www.ispe.org/certified-pharmaceutical-industry-professional/item-writing-manual.doc

Date added: August 8, 2013 - Views: 6