No time or travel budget to attend one of our
Public Training Classes
?
Looking for the
latest Skills and Knowledge to advance your career?
Need training you can
complete any time of the day, week, or weekend?
Need audio, visual, and hands-on elements to maximize training
effectiveness?
Then the
Norton Training
Institute On-Line Training may be what you are looking for:
-
Developed by Former FDA Investigators and Current Industry Auditors, Instructors and
Consultants
-
On-Line Internet-Based Subscription Training
-
Available 24/7 during your Subscription
-
Start, Pause, Restart and Repeat Training as often as you
like
-
CEUs Included with Every Course
-
Training Includes Audio, Visual and Hands-On
Content:
-
Instructor Narration over Graphical Text
-
Digital Library of Reference Materials
-
Terms Glossary
-
Frequently Asked Questions
-
Area to Record your Personal Training Notes
-
Pass/Fail Quizzes to Ensure Learning
-
Personal Training Certificate. CEUs also
available
-
-
-
Focus on Teaching Usable Skills
-
Applicable Laws, Regulation, GCP and ICH References
-
Real World Experience-Based Case Studies
-
Generally 1 to 4 Hours in Length
|
"I love the whole course style, interface, visuals, and the audio. I like your program
better than my online Masters Program."
Ronjula; CRA Program On-Line Student, June, 2009
|
|
"I had a VERY non-compliant site and using your methods and ideas, I was able to bring them
back into compliance (and exceed the ICH/GCP). They just had an audit and the person conducting the
audit was very impressed with our hard work. Norton Training has been a God send!"
Marti; Senior CRA and On-Line Student, May, 2007
|
Modules Available Now :
-
-
Learn the History of Clinical Investigations
-
Understand the Complete Drug Development Process
-
Explains the Purpose and Objectives of Monitoring Clinical
Trials
-
Presents the Requirements for Monitoring Established by
Regulations and Federal Law
-
-
Identifying Compliance Concerns Upfront, before Research
is Conducted
-
Teaches the Systematic Skills for Inspecting a Clinical
Investigator, Including:
-
Interviewing, Human Research Protection
-
Quality Systems, Training, Form FDA 1572
-
Equipment, Staff and Regulation Knowledge
-
-
Presents the Key Quality Systems for
Investigators
-
Major trends of Clinical Investigator
Noncompliance
-
Examine why Noncompliance occurs within Clinical
Trials
-
Implementing Corrective and Preventative Actions (CAPA)
-
Four Hours of Core Content plus Research
Assignments
-
For Auditors, Monitors, Coordinators, Investigators and
Site Staff
Complete Training Programs Available Now:
Clinical
Research Associate
|
"I feel like there is somebody there and it is not just a class on the web. The
opportunity for a chat was great. My overall impression is one of Norton Audits being a
serious professional company. The class is easy to access and run."
Michelle; On-Line Student, October, 2005
|
Complete Training Programs Available Soon:
Clinical
Research Coordinator
Modules Available Soon Include
:
Clinical Investigators and Research Coordinators
Clinical Research Auditing
-
Trend Analysis Skills
-
Auditing the Informed Consent Process
-
Norton Methods: Skill-Based Auditing Techniques – Series
One
-
Norton Methods: Skill-Based Auditing Techniques – Series
Two
-
Norton Methods: Skill-Based Auditing Techniques – Series
Three
-
Examining Causality of Institutional Review Boards
Noncompliance
-
Examining Causality of Sponsor and Contract Research
Organizations Noncompliance
Monitoring
-
Inspecting Clinical Research Facilities
-
Concepts of Quality Systems Methods of Monitoring
-
Conducting Quality Systems Assessments of Clinical
Investigators
Skills for All Clinical Research Professionals
-
Complaint Management Skills
-
Effective Regulatory Writing Skills
-
Effective Professional Interviewing Skills
-
Detection and Prevention of Fraud and Misconduct
Industry Basics and Trends
-
Good Clinical Practice Law
-
Expanding GCP to Incorporate ICH
-
2005 Clinical Research Noncompliance Trends
Standard Operating Procedures
For more information or Assistance in Course
Registration, please
contact us.
-
-
Famous Cases
-
Legal, FDA and ICH Definitions
- Detection, Prevention and Causation
-
Who is Blamed for and Who Commits
-
Whistleblower and False Claims Laws
-
Umbrella of Protection to Prevent and
Detect
-
FDA Process for Responding to Claims and
Complaints
-
How to Document, Burden of Proof and
Elements to Prove
-
Responsibilities of Sponsors, CROs, IRBs, and
Investigators
-
Legal Training for Determining Qualifications of Clinical
Investigators
- Build regulatory and legal skills
- Understanding of binding and legal agreements
between:
- FDA
- Sponsor
- IRB
- Clinical Investigator
- Study Team
- Learn laws governing the investigator's necessary
qualifications for:
- Receiving investigational drugs
- Conducting clinical research
- Examine laws as related to determining
investigator's qualifications to receive and treat with investigational drugs:
- 21 Title CFR 312
- FDA's Compliance Policy Program 7248.811
- Form FDA-1572
- International Conference on Harmonisation
(ICH)
|
"Your on-line demo is great. It gave me the confidence in what I was paying for and
we really like the fact that each module is narrated."
Jen; CRO Owner and On-Line CRA Program Customer, February, 2006
|
|