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| Norton Audits to Present at SoCRA Device Research Workshop |
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03.05.2008
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'Emerging Trends in Device Audit Findings' on June 27 in San Diego
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| Norton Audits to Present at ACRP 2008 Global Conference |
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01.23.2008
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'Advanced Auditing: CSI (Clinical Science Investigations) and The Code' Highlight 5th Year
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Quality Systems-Focused Professionals providing the expertise to meet your Pharmaceutical and Medical Device Clinical Research Trial objectives in:
- Training – Skill-Based GCP,
GMP and Regulatory Law Compliance Education for Auditors,
Monitors, Coordinators and Investigators
- Auditing – Risk and Compliance Audits of Your
Protocols, Procedures and Activities
- Consulting – Expert Advisement and Services for
Sponsors, CROs, IRBs and Investigator Sites
- Publications – How-To Manuals, Reference Guides and
Standard Operating Procedures
- Clinical Investigator Services – Obtaining
Trials, Infrastructure, Training and Procedures for the Experienced and Start-Up Investigator
NAI Professionals have experience in all of our Services Areas and thus offer our clients a Big Picture of Compliance within the individual Services we provide. For example, our Trainers also Monitor and Audit, and thus can bring real world case studies to the class room.
From a Compliance Standpoint, NAI retains in-depth knowledge of all of your Regulatory and Industry Standards including:
- FDA Regulations, 21 CFR Parts 11, 50, 54, 56, 312, 314 (Pharmaceuticals) 812, and 814 (Medical Devices)
- Office of Inspector General (OIG) Mandates
- FDA Compliance Programs 7348.809, 7348.810, and 7348.811
U.S.C. Title 18
- International Conference of Harmonization (ICH) Guidelines
- FDA Quality System Inspection Technique (QSIT)
- Good Clinical Practices (GCP)
- Good Manufacturing Practices (GMP)
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