History Of FDA And FDA Regulations

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 Minutes
Product Description

Learn about the history of FDA regulations and HIPAA protocols in a compliant Clinical Trial program

Conducting clinical trials is certainly a way to optimize financial returns for many hospital,clinics and CROs. The level of oversight and regulations needed for clinical trials have become more intensified in recent years. You would definitely not want to lose revenue just because your staff is not updated or well trained.

Prepare your staff to be ready to do clinical trials with this expert  training session with our presenter Richard Chamberlain. This session is helpful to anyone in a hospital, clinic or a CRO who might be involved in conducting a clinical trial. By the end of the session, you should be well versed with the FDA regulatory compliance in Clinical Research.

The session will take you through a history of the FDA regulations and an introduction to accessing the regulations on the FDA home page.

Here’s just a sample of what you’ll learn:

• Get the complete history of FDA regulations
• Introduce yourself to European regulations and harmonization
• Know how to access the regulations and guidelines that apply to clinical research
• Learn how to approach compliance with the regulations
• Get an Introduction to HIPAA compliance and privacy.
• Learn about EMR – Electronic Medical Records
• Regulations that Apply to Clinical Research
• Guidance that Apply to Clinical Research
• You and the Regulations
• Financial Disclosure by the Investigator

  • Institutional Review Boards
  • Patient Informed Consent
  • Part 11 – Electronic Signature and Electronic Records

• Risk Management – Guidances

  • Quality Management – Guidances
  • Adverse Event Reporting
  • What Records do you have?

• Different Kinds of Audits

  • Qualification – Can you do it?
  • Follow-up – Did you do it?
  • For Cause – There is a serious problem

• Clinical Trial Data Collection Process

  • Patient has a Value – BP, Potassium Level, etc.
  • Must Measure or Observe the Value
  • Use an Instrument
  • Enter the value in the Computer (Correctly)
  • Run Edit Checks and Correct
  • Lock Database and do Analyses
  • And Much More...

Who should attend? Nursing staff, Physicians, Clinical Pharmacists, Lab Technicians, Finance/Accounting, IT, Marketing personnel, Clinical Research Associates, Biometric Specialists, Data Managers, Medical Writers, Regulatory Affairs Specialist, Statisticians and Contracting Professionals

Order Below or Call 1-866-458-2965 Today

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

About Our Speaker

Dr. Richard Chamberlain - Pharma Compliance Expert

Dr. Richard Chamberlain has provided executive consulting services to numerous Pharmaceutical, Biotechnical, Medical Device companies, and international Contract Research Organizations in the areas of strategic planning project management for the development of computerized project management tools and Computer Systems Validation.

Richard
managed large-scale clinical projects from the project planning phase until project closure. He has taught numerous public and in-house courses on various topics such as: Computer Systems...   More Info
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