Take advantage of our $765.000 price by registering early!
* After Thursday, March 14, 2019, costs are $945.000.
course will prepare participants for FDA pre-approval inspections, for
pharmaceuticals, biologics, or medical devices. Sponsor/CRO inspections will be
addressed. Not only will we review the documents sponsors and CROs need to
provide for a GCP inspection, but also the FDA’s rationale for different lines
of questioning. Data shows prepared sponsors and CROs are more likely to have a
The course will focus on a
detailed review of the FDA Compliance Programs. For each topic in the
Compliance Program, the questions the sponsor should expect, different ways
questioning will be completed, and the types of documentation to be provided to
readily satisfy FDA requests will be outlined. The information covered can be
used to prepare Inspection Management teams and Subject Matter Experts.
- Understand what to prepare/FDA inspection
- Identify what you can do on site to
prepare for an FDA inspection
- Learn what to expect and provide
during an FDA inspection
- Apply learning to real-life
situations by inspecting records using FDA techniques
- Directors and Managers, Clinical Operations
- Quality Assurance Professionals
- Regulatory Affairs Professionals
- Clinical Research Associates
- Project Managers
- Personnel responsible for inspection
The course will be led by one of the following
Morris, B.S., MT (ASCP)
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Day One: 8:30 a.m. – 5:00 p.m.
- Regulatory Inspections of Sponsors
- The standards
- Logistics and pre-inspection activities
- Sponsor/CRO inspections
- Post inspection
- Case study
- Inspect sample records from the sponsor/CRO using
the same techniques as the FDA
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that
will be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
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Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 7 hours (0.7 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-19-030-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1