Similar sites like 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.

Categories: Business, Business
Topics: cfr, consulting and training, elearning, fda, fda consultants, fda regulatory compliance, fda warning letter, fda-483, guerra, inc., online training, webseminar

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guerraconsultinggroup.com
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fdaregulatory.com

fdaregulatory.com 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.com 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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pennynorthcutt.com

pennynorthcutt.com pennynorthcutt.com           
PennyNorthcutt.Com - A REGSolutions Company
REGSolutions, LLC provides strategic consulting for medical device regulatory affairs, quality and clinical needs, including registrations for market entry in the USA and European (EU), regulatory rescue, quality system builds, and clinical registrations (IRB, IDE).


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launsby.com

launsby.com launsby.com           
Launsby Consulting - Keeping Industry Competitive
Design of Experiments, Six Sigma and Quality Control Training. Books, Training Tools, Statapult, Catapult, Online Training, E-Learning, Webinars, 8D Problem Solving, MSA Gage, Process Validation, FMEA


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lonestarpharmtox.com

lonestarpharmtox.com lonestarpharmtox.com           
Welcome!
LoneStar PharmTox LLC is an experienced pharmadevelopment and toxicology consulting company with the additional formulation, manufacturing, packaging and regulatory affairs necessary to assist in reducing development cycle time and to bring innovative, safe and sustaining products to market,toxicology consultant, tox consultant, nanotechnology,safety



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skillsplusinc.com

skillsplusinc.com skillsplusinc.com           
SkillsPlus International Inc - Compliance Training Experts GMP QSR Designated Representative and Exemptees
Designated Representative Training Courses. GMP Training. Exemptee Training. Popular and well-respected. Offering the most choices in GMP training services and trainer support.


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aquamarinegroup.com

aquamarinegroup.com aquamarinegroup.com           
Welcome to The AquaMarine Group, Inc.
Since 1996, The AquaMarine Group, Inc.’s services have been sought and retained by pharmaceutical firms, to furnish expertise in the areas of regulatory review, application writing, cGMP compliance/mock pre-approval audit services, R&D portfolio analysis, contracted management services, and new product/technology evaluation and promotion. Services furnished to clients include not only review and commentary, but have also included project management for a number of significant filings.


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eduquest.net

eduquest.net eduquest.net           
FDA Compliance Training, Consulting and Regulatory Advice
EduQuest, a global team of FDA compliance experts, including former FDA inspectors and rule-makers. Provides FDA training, consulting and advice.



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fdaregulatorycomplianceadvisors.com

fdaregulatorycomplianceadvisors.com fdaregulatorycomplianceadvisors.com           
FDA Regulatory Compliance Advisors, Inc. - “Combining science with regulatory knowledge for optimized systemic solutions” ™
We provide technical and FDA regulatory knowledge to lay the foundation for optimized processes and robust systems that are key in the prevention of FDA-483s and FDA Warning Letters.


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validationplus.com

validationplus.com validationplus.com           
Validation Plus, Inc.
Validaton Services, Validation Engineering, Good Tissue Practice, 21 CFR Part 11 solution provider


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beqs.com

beqs.com beqs.com           
BEQS - Consulting for Medical Device and Pharmaceutical Industry
Bacchus Engineering & Quality Solutions for Medical Manufacturing Consulting



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regulatory.com

regulatory.com regulatory.com           
FDA Regulatory Consulting | International Services | AccuReg Inc.
AccuReg is a regulatory, compliance and technical consulting firm serving companies engaged in the development and manufacture of healthcare products regulated by the U.S. FDA. Founded in 1987, AccuReg works with clients world-wide to bring new products to market and maintain compliant Quality Systems.



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accufastconsulting.com

accufastconsulting.com accufastconsulting.com           
AccuFast Consulting - Phoenix Arizona AZ - ISO 9001 ISO9001 ISO-9001 ISO 13485 ISO13485 ISO-13485 ISO 14000 ISO14000 ISO-14000 AS-9100 AS9100 AS 9100 QS-9000 QS9000 QS 9000...
AccuFast Consulting - Affordable Manufacturing/Quality Systems Consulting - Offering a broad range of manufacturing and quality systems consulting services, at lower total cost. Specializing in ISO, GMP, and military quality systems. Consultants' expertise include manufacturing, purchasing, supplier management, and project management, in the electronics, semiconductor, medical device, aerospace, and military sectors. Consulting firm primarily supporting small to medium manufacturing companies in Arizona and the Southwest. Services tailored to meet the customer's needs. Guaranteed 100% customer satisfaction, with affordable total costs. [ ISO 9001:2000 ISO 9001 ISO9001 ISO-9001 ISO 13485 ISO13485 ISO-13485 ISO 14000 ISO14000 ISO-14000 AS-9000 AS9000 AS 9000 QS-9000 QS9000 QS 9000 Baldrige Criteria


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rapidmicromethods.com

rapidmicromethods.com rapidmicromethods.com           
Rapid Microbiology and Rapid Microbiological Methods
Welcome to the most comprehensive, educational online resource for rapid microbiology technologies, regulatory policies, validation strategies, current trends, expert training and consulting.



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sustainablehawaii.com

sustainablehawaii.com sustainablehawaii.com           
Rezachek & Associates Home Page
Home page of Rezachek & Associates - Rezachek & Associates is an international energy and environmental engineering consulting group with its base of operations located in Hawaii, USA. Rezachek & Associates provides consulting, research, and project management services to federal laboratories, universities, government agencies, non-profit organizations and industry in a variety of renewable energy, energy conservation, and environmental areas.


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kereon.ch

kereon.ch 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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gmpseminars.com

gmpseminars.com gmpseminars.com           
GMP | Good Manufacturing Practices Compliance Training | Pharmaceutical
PharmaNet® specializes in the development and presentation of seminars, educational programs and courses associated with good manufacturing compliance requirements for the pharmaceutical and active pharmaceutical ingredient (API) industries.


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fdacompliancespecialists.com

fdacompliancespecialists.com 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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biopharminternational.com

biopharminternational.com biopharminternational.com           
BioPharm International
BioPharm International is the independent source for technical solutions and business insight for biopharmaceutical research, development, and manufacturing.


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calisouk.com

calisouk.com calisouk.com           
Calibration Toolbox ADO - Calibration Management Software and Temperature Calibration Software - from Humpage Technology
Calibration Toolbox ADO calibration management software enables ISO 9000 , ISO/IEC 17025 , 21CFR Part 11 calibrations .


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swqual.com

swqual.com swqual.com           
Consulting, training and auditing services for medical device, biotech and pharma industries
Consulting, training and auditing services for safety critical industries



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ivthome.com

ivthome.com ivthome.com           
Account Suspended


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aabc-inc.com

aabc-inc.com aabc-inc.com           
AABC Testing and Certification, Inc.
AABC provides Certification, Air Balancing, and Specialty Testing Services in Northern and Southern California



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eduneering.com

eduneering.com 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.com 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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fda.com

fda.com 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 Fédération 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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norfeldt.com

norfeldt.com norfeldt.com           
NORFELDT - Home
Qualified Consulting for GxP Apps


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ccsi-inc.com

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CCSi Testing Instruments, Equipment, Physical Testing, Calibration & Related Services
Physical Testing and Laboratory Instruments, Processing and Specimen Preparation Equipment, Physical Testing, Calibration and Related Services for the Characterization of Plastomers, Elastomers, and Textiles


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ivyworks.net ivyworks.net           
Welcome to IVY Works : consulting and support services for compliance, validation, Computerized System Validation, IT Infrastructure Qualification and IT Solutions Pharma, Biotech, life sciences industry
Validation Services, Compliance Services, Pharma Consulting, Validation Support, Compliance, Validation, Computerized System Validation, IT Infrastructure Qualification and IT Solutions Pharma, Biotech, life sciences industry, IVY Works Advisors LLP provides compliance services to improve operational efficiency with 21 CFR Part 11 and GxPs. CSI anticipates, defines, evaluates and solves the technical and regulatory issues that arise in a constantly changing environment to help clients achieve their business goals.


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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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mech-chem.com mech-chem.com           
Home - Mech-Chem
Mech-Chem's chemical process design, engineering, fabrication, and construction of manufacturing facilities; operating processes; acid, chemical, and waste recovery systems; and environmental control systems.


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sabalfsc.com sabalfsc.com           
Sabal Food Safety Consulting
Sabal Food Safety Consulting


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raland.com

raland.com 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

arkinconsulting.com 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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relamatrix.com

relamatrix.com relamatrix.com           
Relamatrix services from Healthcare and ehealth, pharmaceutical and traditional FDA/regulatory expertise to public relations and corporate communications
A healthcare and pharmaceutical consulting and marketing service, Relamatrix offers turn-key services for manufacturers to enter the United States healthcare market.



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airconomics.com

airconomics.com airconomics.com           
AIRconomics GmbH - Aviation Consulting & Training Germany
AIRconomics GmbH is an Aviation Consulting & Training company in Germany. We deliver high-quality solutions to airlines, airports and manufacturers.


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EDF Help Desk
EDF Help Desk provides support to organizations and individuals preparing or receiving EDF standards. These organizations include environmental firms, laboratories, responsible parties and local, state and federal agencies.



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hammondctc.com hammondctc.com           
Home - Hammond Clinical Trial Consulting, LLC
Hammond Clinical Trial Consulting, LLC


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mournetrainingservices.co.uk

mournetrainingservices.co.uk mournetrainingservices.co.uk           
Expertise in Analytical Chemistry for Pharma
Mourne Training Services Limited (MTS) is an independent consultancy specialising in pharmaceutical and biopharmaceutical analysis and providing training, consultancy and auditing solutions. Training course topics are primarily: Analytical method validation, verification and transfer; HPLC (includes introductory level courses, method development and troubleshooting courses); laboratory data integrity; stability indicating methods and forced degaradtion; and Out of Specification (OOS) investigations. They are delivered as open enrolment courses in London, Berlin and Dublin or a live online events. Cousrse are also available at the customer site with bespoke content as required. Consultancy services include advice on any topic related to the pharma lab, e.g., cGMP in the laboratory; effective laboratory practices; human error reduction; robust method development; method validation and transfer, out of specification investigations, etc. Auditing services are focused on the laboratory with emphasis on data integrity. Audits may be against best practice or to a particular standard, e.g., EU GMP.


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worldcomplianceseminars.com worldcomplianceseminars.com           
WCS- Life Science Training Institute, FDA Regulatory Compliance Training
WCS is Training Institute provides best certificate courses online for the pharmaceutical, FDA, life science, biotech, medical device, and skin/cosmetics industries


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gratisol.com

gratisol.com gratisol.com           
Best Institute for Clinical Research in Hyderabad - Gratisol Labs
Best Institute for Clinical Research in Hyderabad - Gratisol Labs. Clinical Research Courses: Pharmacovigilance, Medical Writing, Clinical SAS, Medical Writing & Pre Placement Training.


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biopharmainstitute.com

biopharmainstitute.com biopharmainstitute.com           
Biopharma Institute- GxP Compliance and Regulatory Training
Regulatory and GxP compliance training for pharmaceutical, medical device, and clinical research professionals


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validationcenter.com

validationcenter.com validationcenter.com           
Everything you need for Computer System Validation and SQA
CSV Training and consulting. Download from the largest library of validation templates and FDA Warnings. Our 21 CFR Part 11 experts can validate for you.


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