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ISO Medical Device Training Courses ISO training

Quality & ISO - ISO

Quality/ISO - Medical Device Industry

For more information about ISO Medical Device training, trainers and seminars please click on the course titles or the vendor names below.

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Title Provider Delivery Format Primary Office Language Get Info
An Overview of the Electronic Records and Signature Rule - 21 CFR Part 11SAI GlobalPublic & Onsite
Schedule
USAEnglish
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This 1 day course discusses why Title 21 of Code of Federal Regulations Part 11 was developed, the evolution of the regulations, the role Part 11 plays in the adherence to other sections of 21 CFR, and explores the impact of compliance for your organization.
Incorporating Supplier Quality Management Techniques in FDA Regulated BusinessesSAI GlobalPublic & Onsite
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USAEnglish
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Learn the methodologies needed to successfully implement a quality management process (including supplier assessment,audit and evaluation) that integrates supplier chain management with FDA Quality System Regulation and ISO 13485:2003 as well as ISO 9001:2008.
Effective Corrective and Preventive Action for FDA Regulated IndustriesSAI GlobalPublic & Onsite
Schedule
USAEnglish
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SAI Global's 2-day course is crafted to give the attendee a thorough understanding of not only what Corrective Action is, but also the difference between what the FDA requires for CAPA and what ISO 13485:2003 and ISO 9001:2008 require.
RABQSA Certified FDA Regulated Industries Lead Auditor (ISO 9001/ISO 13485)SAI GlobalPublic & Onsite
Schedule
USAEnglish
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This 5-day, highly participative course provides comprehensive instruction on auditing quality management systems. Reference is made to the international guide on quality systems auditing (ISO 19011), as well as to the ISO 13485:2003 and 9001:2008 standards.
ISO13485 Training & ConsultingDarmic ConsultingOnsite,Public & OnsiteUSAEnglish
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Deliver comprehensive and fast track 13485 training & consulting services nationwide! We also do quality manual development, process engineering, and internal audits. We train on ISO standards including 9001, 14001, 20000, 22000, and 31000.
Design Control for the Medical Device IndustrySAI GlobalPublic & Onsite
Schedule
USAEnglish
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In this 2-day course, attendees will gain a thorough understanding of: the need for Design Control; similarities and differences between ISO 9001, ISO 13485 and QSR.
Internal Auditor Training for FDA Regulated Industries (ISO 13485 and ISO 9001)SAI GlobalPublic & Onsite
Schedule
USAEnglish
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This 2 day course provides the information and skills needed to effectively perform a comprehensive quality system audit that complies with ISO 13485:2003, ISO 9001:2008 and regulatory requirements.
Quality System Regulation (QSR) for the Medical Device IndustrySAI GlobalPublic & Onsite
Schedule
USAEnglish
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This 2-day course is designed to give you the most updated information on the FDA requirements for the QSR (Quality System Regulation) as defined by 21 CFR Part 820 and product safety.
Understanding and Implementing the ISO 13485 StandardSAI GlobalPublic & Onsite
Schedule
USAEnglish
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This 2-day will guide companies toward reviewing current processes and systems, planning for change, and understanding the challenges and benefits of meeting/certifying to ISO 13485.
Understanding 21 CFR 210 and 211SAI GlobalPublic & Onsite
Schedule
USAEnglish
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Receive a detailed introduction about cGMPs(current Good Manufacturing Practices) as defined by 21 CFR part 210 and 211 and how it can positively affect your organization in this 2 day course.
ISO 9000:2000 Internal Auditing CourseQuality Management ExchangePublic & OnsiteUSAEnglish
ISO 9000:2000 INTERNAL AUDITOR Training,1-3 days,What are changes to theISO 9000:2000?,What to Look For As an Auditor,Auditing Techniques,Developing a Checklist,Questioning Techniques&Perform an actual audit.
Understanding FDA Regulations for Combo ProductsSAI GlobalPublic & Onsite
Schedule
USAEnglish
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With this 2 day course, you will gain a thorough understanding of what is required for devices and drugs through analysis of the FDA requirements specified in 21 CFR 820 and 21 CFR 210/211 and related CFRs as applicable.
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