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Method Development and Validation for Assays Supporting Testing of Biologics
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device...
Preparing for FDA's New Import/Export Trauma in 2020
Introduction into the EU IVDR 2017/746 - the new EU regulation for invitro diagno...
Fundamentals of EU MDR and IVDR – Level 1
Analytical Instrument Qualification and System Validation
REACH and RoHS Compliance: Gain a Deeper Understanding
Why is FDA at my facility, and what do I do during an inspection?
Ensuring Compliance with Advertising and Promotional Requirements for Drugs...
Managing Your Complaints and Obstacles in Post-Market Requirements -- Results...
Sexual Harassment Certificate Program for HR Professionals
OSHA and Workers Compensation Certificate Program
FMLA, ADA and PDA Certificate Program
Employment Laws Certificate Program for HR Professionals, Managers and Super...
Project Management for Human Resources
How to Conduct a Workplace Harassment, Bullying & Violence Investigations Tra...
Data Integrity: FDA/EU Requirements and Implementation
Operations Risk Management and Mitigation - from assessment to implementation
Technical Writing for Pharma, Biotech and Medical Devices
Risk Based Internal Auditing (RBIA)
Lifecycle Management of Analytical Methods and Procedures - according to new...
Validation, Verification and Transfer of Analytical Methods (Understanding and...
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Software Engineering Process Technology (SEPT)
Software Engineering Process Technology Company, (SEPT) is a firm specializing in meeting the software standards information needs of the professional community, particularly concerning ISO/IEC 12207. SEPT provides standards information via books, checklists, reports, and consulting.Computer Hardware
FDA Audit, Validation & Documentation
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Configuration, Acronyms & Abbreviations in Technical Writing
Price: $6 -
Electronic Signatures; Final Rule-FDA 21CFR Part 11
Price: $149 -
ISO 9001:2015 ''Quality Management Systems - Requirements 2015 Edition''
Price: $299 -
ISO/IEC/IEEE 90003:2018 "Software Engineering: Guidelines for the application of ISO 9001:2015 to computer software"
Price: $167
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Configuration, Acronyms & Abbreviations in Technical Writing
IT and PCI Compliance
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ISO/IEC Standard 15288:2008-Systems and Software Engineering-System Life Cycle Processes - (Second Edition)
Price: $299 -
Guide to Software Engineering Standards and Specifications 1
Price: $299 -
Guide to Software Engineering Standards and Specifications 2
Price: $30 -
Guide to Software Engineering Standards and Specifications 3
Price: $30
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ISO/IEC Standard 15288:2008-Systems and Software Engineering-System Life Cycle Processes - (Second Edition)
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Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices
Price: $299 -
Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices - May 11, 2005
Price: $299 -
Checklist for Standard ISO/IEC 27002:2013 - Information Security Code of Practice
Price: $399 -
FDA, General Principles of Software Validation Final Guidance for Industry and FDA Staff (Release date January 11, 2002)
Price: $99
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Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices
Manufacturing Engineering
Medical Device and Healthcare Technology
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Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices
Price: $299 -
Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices - May 11, 2005
Price: $299 -
ISO 13485:2016 “Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes”
Price: $149 -
Medical Software Checklist Kit
Price: $1549
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Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices
Quality Terminologies & Documentations
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Checklist for Standard ISO 9004:2018
Price: $330
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Checklist for Standard ISO 9004:2018
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