Hosting for Regulatory Inspections

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Prepare for and Manage an FDA inspection Effectively with These Useful Tips

Many Hospitals and Clinics today are looking for ways to enhance revenues. One sure-fire way is for them to perform more clinical trials. In order to do this they must train their staffs to be ready to do clinical trials.

Prepare your staff to be ready to do clinical trials with this power packed regulatory inspection training session with our presenter Richard Chamberlain. This is a training session that will help them deal with an FDA inspection should they have one. This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial must take. In case they have never been involved they will discover what one is, in case they have done clinical trials it will be helpful to put everyone on the same level as far as terms and operations.

Typically FDA inspections can be highly structured and there are usually procedures that are to be followed. It is important for anyone who might be involved in the inspection to be aware of these procedures. The course will go through what typically goes on during an FDA inspection and the things that you should do or not do during the inspection.

Here are a few topics covered in the session:

  • Types of inspections
  • What goes on during the inspection?
  • Who is involved?
  • The SOP for Inspections
  • What if you are asked to talk to the inspector?
  • What do you allow the inspector to have access to?

Who should attend? Anyone who is involved in a Clinical Trial

  • Nursing staff
  • Physicians
  • Pharmacists
  • Lab Technicians
  • IT

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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.

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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