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DARQA webinar GCP audits and inspections experiences

DARQA Dutch Association of Research Quality Assurance

De vereniging heeft tot doel het uitwisselen op informele wijze van informatie op het gebied van regelgeving, kwaliteitsystemen en kwaliteit van uitvoering studies (klinisch, veterinair, toxicologisch, eco(toxico)logisch en laboratorium.

Quality Assurance, QA, GLP, GCP, GMP, ICT, GCLP, GxP

Categories: Business, General Organizations
Topics: ema, gamp, gclp, gcp, glp, gmp, good practices, gxp, oecd, qa

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gmppublications.com
Welcome to GMP Publications
Code of Federal Regulations Mini-Handbooks as provided by the Food and Drug Administration FDA. The laws for Pharmaceuticals, BioTechnology, Medical Device and Regulatory Industry. Quality Assurance QA, Blood, Biologics, Drug and Food Industry

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guerraconsultinggroup.com
FDA Regulatory Compliance - Mentoring, Coaching, Consulting and Training
Learn Guerra’s proven method for preventing FDA-483 and Warning Letters. Learn how to document failure investigations and quality events. Prevent data integrity issues in GMP facilities.

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fdaregulatory.com
GMP GCP GLP Training Resources - Free FDA regulations documents
GMP GCP GLP Books - Free FDA Regulations Information - clinical trial and medical comparator drug information

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auditing.com
Auditing - The Auditing Group and Validations.com GMP - GLP - GCP Part 11 Audits
Auditing, GMP, Audits, Audit and GMP Auditing Part 11 and Part 820 Auditing and Training services for the Pharmaceutical, Biotechnolgy, Medical Device, Food and Cosmetic Regulated Industry by Industry Professionals. FDA.COM is the next step for professionals seeking compliance information through discussion groups and on-line information sharing. Directed by John Cuspilich, Director Regulatory Affairs and Michael Van Horn, Director Sales and Marketing, companies can get noticed by over 100,000 visitors monthly. GXP Academy is the world's leader in GMP Training and GMP Management Auditing services. GMP Publications is the world's leader in GMP Mini-Regulation Handbooks serving the regulatory community in search of 21 Code of Federal Regulations. Serving the Global Community by assisting global harmonization, and through the International Conference of Harmonization

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zifornd.com
Scientific Informatics Services Company | Delivery & Managed Services | Zifo
We help science-driven organisations innovate for a better future through our full range of specialist scientific informatics & managed healthcare IT services.

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horn-pharma.de
Horn Pharmaceutical Consulting - ASMF, Active Substance Master File, US-DMF, Drug Master File, Certificate of suitability, CEP, CTA ,Clinical Trial Application, IND, Investigational New Drug Application, CTD, Common Technical Document, European MAA, Marketing Authorization Application, NDA, New Drug Application / BLA, Biologic License Application, SPCs, Summary of Product Characteristics, clinical or nonclinical study protocols and reports, clinical or nonclinical summaries and overviews, qualit
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skillsplusinc.com
SkillsPlus International Inc - Compliance Training Experts GMP QSR Designated Representative and Exemptees
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ivtnetwork.com
IVT Journal Archive - BioProcess InternationalBioProcess International
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pharmbiotest.com.ua
Клинико-Диагностический Центр Фармбиотест
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darqa.nl
Nieuws - www.darqa.org
DARQA Dutch Association of Research Quality Assurance

De vereniging heeft tot doel het uitwisselen op informele wijze van informatie op het gebied van regelgeving, kwaliteitsystemen en kwaliteit van uitvoering studies (klinisch, veterinair, toxicologisch, eco(toxico)logisch en laboratorium.

Quality Assurance, QA, GLP, GCP, GMP, ICT, GCLP, GxP

Categories: Business, Business

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barqa.com
Training Courses, Membership, Publications | Research Quality Association | RQA
Training Courses, Membership, Publications | Research Quality Association | RQA

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mlims.jp
LIMS｜LABVANTAGE（ラブヴァンテージ）｜ラボラトリー情報管理システム
LABVANTAGE（ラブヴァンテージ）は、三菱スペース・ソフトウエアによるラボラトリー情報管理システム（LIMS）です。

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polarisconsultants.com
Polaris Compliance Consultants, Inc. - Home
Compliance and Quality Consulting for the Life Science Industry

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kereon.ch
Kereon AG / IT-Quality Management: Development, Infrastructure, regulated Good Practices (GxP), GAMP
www.kereon.ch - Kereon AG - Engineering and IT Consulting around GAMP�, CSV, and e-compliance

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fdacompliancespecialists.com
Home - fdacompliancespecialists.com
FDA Compliance Specialists, Inc. specializes in providing Global GxP, Medical Device, 21 CFR Part 11, and Supplier Quality Auditing, Computer System Validation, Inspection Readiness, and FDA Compliance and Quality Training Services to the Pharmaceutical, Medical Device, and Biotechnology regulated industries. The Quality of our services are best in class meaning we provide more benefits and value-added services for less money! Our cost-effective, highly credentialed FDA Compliance Specialists strengthen and improve the effectiveness of corporate internal and global supplier audit programs, computerized systems compliance, inspection readiness, and quality management system initiatives.

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softwaretestingstuff.com
Software Testing Stuff - Discover the best testing tools and elevate your testing game
Welcome to Software Testing Stuff - your ultimate resource for unbiased tool reviews, comprehensive guides, and valuable insights to elevate your testing game. Join our community of testers and discover the best solutions to ace your software testing projects.

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lims-software.com
Maintenance

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ivthome.com
Account Suspended

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eduneering.com
UL EduNeering: Online Regulatory and Compliance Learning
UL Quality, Compliance and Learning provides online training programs and courses that are designed to improve workforce performance and reduce the business risks associated with non-compliance.

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axys-network.com
AXYS-NETWORK-Pharmaceutical consulting firm
Axys-network is a pharmaceutical consulting firm specializing in aseptic processes and in Transition Management - Manufacturing, Quality, Regulatory. Remediation experts for troubleshooting and continuous improvement

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lsp-c.com
株式会社エルエスピー
ライフサイエンスの分野において新しい技術を用いた、より迅速で対費用効果の高い開発への貢献

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fda.com
FDA.COM Information Portal
On-Line Discussion Groups and Information Portal serving the Pharmaceutical, Biotechnolgy, Medical Device, Food and Cosmetic Regulated Industry by Industry Professionals. FDA.COM is the next step for professionals seeking compliance information through discussion groups and on-line information sharing. Directed by John Cuspilich, Director Regulatory Affairs and Michael Van Horn, Director Sales and Marketing, companies can get noticed by over 100,000 visitors monthly. GXP Academy is the world's leader in GMP Training and GMP Management Auditing services. GMP Publications is the world's leader in GMP Mini-Regulation Handbooks serving the regulatory community in search of 21 Code of Federal Regulations. Serving the Global Community by assisting global harmonization, and through the International Conference of Harmonization International sport governing body. The FÃ©dÃ©ration Internationale de l'Automobile (FIA; English: International Automobile Federation) is an association established on 20 June 1904 to represent the interests of motoring organisations and motor car users. It is the governing body for many auto racing events, including Formula One. The FIA also promotes road safety around the world. Headquartered at 8 Place de la Concorde, Paris, with offices in Geneva and Valleiry, the FIA consists of 246 member organisations in 145 countries worldwide. Its current president is Mohammed bin Sulayem.

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winlims.info
WinLIMS
A page from Quality Systems International QSI about WinLIMS: LIMS by Quality Systems International (WinLIMS)

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qsius.com
LIMS Software | LIMS Systems | WinLIMS by QSI
QSI offers comprehensive LIMS software (Laboratory Information Management Systems). Enhance your lab’s productivity and quality.

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sturnusdesign.com
STURNUS, INC. - Home
Embedded System Design - Firmware from early stage proof-of-concept through architecture, development and manufacture. We source, screen, and support a team of highly skilled technical professionals.

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datacheck.it
DATACHECK - L'Informatica per l'Assicurazione della Qualità
21 cfr part, annex 11, assicurazione, campioni, controlli ambientali, controlli microbiologici, controllo della qualità, cosmetico, dispensing, farmaceutica, farmaceutiche, gamp, glp, gxp, ispe, l.i.m.s., laboratorio, lims, mes, multiple sites lims, produzione, qualità, quality assurance systems, quality control, sala pesate

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it-asso.com
IT-Associatesホームページ
製薬企業のコンピュータ規制適合に必要な情報提供サイト

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nercsqa.org
NERCSQA Home
New England Regional Chapter Society of Quality Assurance

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raland.com
Raland Compliance Partners
Raland Compliance Partners provides regulatory and compliance solutions in the pharmaceutical, biotech, and medical devices industries.

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arkinconsulting.com
Arkin Consulting Group, LLC.
Regulatory affairs consulting FDA ISO medical device cGMP quality assurance control audit submission NDA 510(k) IDE clinical pharmaceutical registered agent compliance recall 483

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immelresources.com
Immel Resources Home Page
Immel Resources is a consulting and publishing firm specializing in regulatory compliance, quality assurance, and training for the pharmaceutical, biotechnology, and medical device industries.

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jouhoukoukai.com
Jouhou Koukai - Japan market access | regulatory & pharmaceutical affairs
Consultants and consulting for regulatory affairs, auditing and training in the pharmaceuticals, biopharmaceuticals, medical devices, in-vitro diagnostics, biologicals, food, beverages, dietary supplements, nutraceuticals, cosmetics, veterinary medicine, healthcare, clinical trials, research, contract and outsoutcing, and life sciences industries

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kaplaneduneering.com
Online Compliance Learning Courses
Our online training programs and courses are designed to improve workforce performance and reduce the business risks associated with non-compliance.

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farbridgepharma.com
Quality Assurance | QA Consultants | United States | Farbridge Pharma
Farbridge Pharma Consulting specializes in GxP Quality Assurance. We work world-wide with pharmaceutical and biotech companies that require external expertise in pharmaceutical Good Practices (GMP, GDP, GVP, GCP). At Farbridge, we truly provide the “Bridge” between Europe and North America.

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sdsnmr.com
Spectral Data Services, Inc. | GMP / GLP NMR (Nuclear Magnetic Resonance) Contract Testing Lab
Spectral Data Services, Inc. is a GMP and GLP NMR (Nuclear Magnetic Resonance) contract testing lab. We have both solution and solid-state NMR capabilities and are DEA registered, serving clients since 1985.

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adwareresearch.hu
Adwaresearch
Adwaresearch

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pharmatex.pl
AimSoft | Software Quality Assurance - Profesjonalne Testy Oprogramowania
Specjalizujemy się w walidacji systemów skomputeryzowanych (CSV) wg GAMP5 u Klientów z branży farmaceutycznej.Świadczymy usługi z zakresu testowania oprogramowania, automatyzacji testów, badania wydajności i usprawniania procesów wytwórczych oprogramowania.

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certusintl.com
Clinical Research with Certus International
Certus International Inc. is an imaging clinical research organization that designs and implements clinical trials for pharmaceutical, biotech, and diagnostic imaging companies.

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comes-compliance.com
Home
comes compliance services (CCS) is an independent, highly experienced, and premier consultancy service provider specializing in simplifying and streamlining EMA, FDA, ICH, ISPE GAMP 5 compliance & quality systems, and fulfilling validation and regulatory compliance requirements. CCS is managed by Markus Roemer.

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locumqp.com
Pharmaceutical Solutions EUQP Qualified Person QP Services
Qualified Person QP services to pharmaceutical, veterinary and industrial companies internationally.

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comes-services.com
Home
comes compliance services (CCS) is an independent, highly experienced, and premier consultancy service provider specializing in simplifying and streamlining EMA, FDA, ICH, ISPE GAMP 5 compliance & quality systems, and fulfilling validation and regulatory compliance requirements. CCS is managed by Markus Roemer.

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site.casadase.net
CASA DA S� - Viseu - Hotel de Charme - Small Luxury Hotel
CASA DA S� - Viseu - Hotel de Charme - Small Luxury Hotel

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