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September 3, 2010
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JOB FUNCTION
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Final AE Regulatory Guidance
September 3, 2010 | $595.00
Source Documentation: What is Adequate & Accurate?
September 7, 2010 | $795.00
10-Week CRA & CRC: Beginner Program (September 8 - November 10. 2010)
September 8, 2010 | $1,895.00
Introduction to Data Management
September 9, 2010 | $695.00
Trial Master File (TMF) for Research Sites: Set-Up and Maintenance
September 9, 2010 | $795.00
Special Considerations in Pediatric Trials for CRAs
September 10, 2010 | $695.00
Monitoring Reports: 10 Rules of Effective Report Writing
September 10, 2010 | $795.00
ABCs of Clinical Research for Clinical Administrative Support Staff
September 13, 2010 | $795.00
Essential Documentation in Clinical Trials at Research Sites
September 14, 2010 | $695.00
Monitoring Informed Consent: The Process and Document
September 14, 2010 | $595.00
Meeting International Safety Reporting Requirements
September 15, 2010 | $695.00
Critical Decision Points in Design & Conduct of Patient Registries
September 16, 2010 | $795.00
Clinical Research Site Quality Improvement Strategies
September 17, 2010 | $595.00
Strategies for Managing Difficult Clinical Research Sites
September 17, 2010 | $795.00
How to Prepare and Submit a Bullet Proof 510(k) Submission
September 20, 2010 | $695.00
Adverse Events for Medical Devices
September 21, 2010 | $695.00
Final FDA Guidance for Supervisory Responsibilities of Investigators
September 21, 2010 | $595.00
Facilitation Skills for Clinical Research Professionals
September 21, 2010 | $695.00
Clinical Trial Design for Medical Devices
September 22, 2010 | $695.00
Clinical Trials for Pharmaceuticals: Design and Development
September 23, 2010 | $695.00
Drug Development and FDA Regulations
September 24, 2010 | $695.00
Recent Trends in Noncompliance
September 27, 2010 | $695.00
Electronic Medical Records
September 28, 2010 | $795.00
Current Developments and Emerging Trends in the Role of Institutional
September 28, 2010 | $595.00
Examining Revisions to the FDA/ORA Compliance Program Guidance Manual
September 29, 2010 | $595.00
FDA's Human Subject Protection /Bioresearch Monitoring Initiative
September 30, 2010 | $595.00
Risk-Based Decisions in Clinical Trial Site Management
September 30, 2010 | $695.00
Use of Notes to File in Clinical Trial Essential Documentation
September 30, 2010 | $795.00
Quality Systems A Controlled Approach to GCP Compliance
October 1, 2010 | $695.00
HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings
October 7, 2010 | $595.00
HIPAA Requirement Changes and Enforcement: Direct and Indirect Impact Analysis for Research Centers
October 8, 2010 | $695.00
Adequate Sponsor Monitoring Systems In Anticipation of FDA Sponsor GCP Inspections
October 8, 2010 | $695.00
Comparing FDA and Health Canada Regulations: Using an ICH GCP Framework
October 12, 2010 | $695.00
Source Documentation: What is Adequate & Accurate?
October 12, 2010 | $795.00
The Fundamentals of Clinical Research Project Management
October 12, 2010 | $695.00
Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies
October 12, 2010 | $795.00
Negotiating Best Practices for Clinical Research Professionals
October 13, 2010 | $695.00
Creating High Performance Virtual Teams
October 13, 2010 | $695.00
10-Week CRA & CRC: Beginner Program (October 14 - December 23, 2010 no class November 25)
October 14, 2010 | $1,895.00
CRC & PI Current Practice Update: Impact of the FDA BIMO Initiative
October 19, 2010 | $595.00
Strategies for Managing Difficult Clinical Research Sites
October 19, 2010 | $795.00
Trial Master File (TMF) for Sponsors: Set-Up and Maintenance
October 21, 2010 | $795.00
Introduction to the FDA
October 21, 2010 | $695.00
CRA Current Practice Update: Impact of the FDA BIMO Program
October 22, 2010 | $695.00
Introduction to Combination Products
October 22, 2010 | $695.00
Sponsor Management of Investigator Non-Compliance
October 22, 2010 | $695.00
Monitoring Reports: 10 Rules of Effective Report Writing
October 26, 2010 | $795.00
Managing CRAs to Improve Performance & Study Outcomes
October 28, 2010 | $595.00
CRA Site Performance Improvement Monitoring Model
October 29, 2010 | $595.00
Use of Notes to File in Clinical Trial Essential Documentation
October 29, 2010 | $795.00
Fraud in Clinical Research: An Overview
November 1, 2010 | $795.00
Approaches to Address Challenges in Vendor Management
November 2, 2010 | $795.00
Good Clinical Practice: Practical Application and Implementation
November 2, 2010 | $795.00
Conflicts of Interest in Clinical Research: Policy and Practice
November 3, 2010 | $695.00
Developing and Negotiating Research Site Clinical Study Budgets and Contracts
November 4, 2010 | $795.00
Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance
November 4, 2010 | $795.00
Sponsor Management of Investigator Non-Compliance
November 5, 2010 | $695.00
Phase I Study Management
November 5, 2010 | $595.00
Facilitation Skills for Clinical Research Professionals
November 5, 2010 | $695.00
Presentation Skills Training for Clinical Research Professionals
November 9, 2010 | $695.00
Study Feasibility: Eliminating Low and Late Enrollment
November 9, 2010 | $595.00
Investigational Product Accountability Training for Research Site Personnel
November 9, 2010 | $795.00
Vendor Management for the Clinical Data Manager
November 10, 2010 | $695.00
Train-the-Trainer: Successful Web-Based Training Strategies
November 11, 2010 | $795.00
Making Good Teams Better: Taking Your Cross-Functional Global Team to the Next Level
November 11, 2010 | $695.00
Root Cause Analysis: Applying the Concept for Better Study Compliance
November 11, 2010 | $595.00
Monitoring Phase I Clinical Trials
November 12, 2010 | $795.00
Special Considerations in Pediatric Trials for CRAs
November 12, 2010 | $795.00
ABCs of Clinical Research for Clinical Administrative Support Staff
November 15, 2010 | $795.00
Investigator Initiated Trials: Roles and Responsibilities
November 16, 2010 | $695.00
Transitioning Pharmaceutical Professionals to Medical Device Professionals
November 16, 2010 | $695.00
FDA 2010 Draft Guidance: IRB Continuing Review of Clinical Investigation
November 16, 2010 | $695.00
Medical Device Reporting
November 17, 2010 | $695.00
Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components
November 18, 2010 | $795.00
Medical Device Tracking
November 18, 2010 | $695.00
Source Documentation: What is Adequate & Accurate?
November 18, 2010 | $795.00
Introduction to Signal Detection and Data Mining
November 22, 2010 | $795.00
Risk-Based Decisions in Clinical Trial Site Management
November 23, 2010 | $695.00
Adequate Investigator Oversight: Gap Analysis Tool for Current Systems
November 23, 2010 | $695.00
Clinical Trials for Pharmaceuticals: Design and Development
November 29, 2010 | $695.00
Strategies for Managing Difficult Clinical Research Sites
November 30, 2010 | $795.00
Drug Development and FDA Regulations
November 30, 2010 | $695.00
Essential Documentation in Clinical Trials at Research Sites
November 30, 2010 | $695.00

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