US GCP Fundamentals for Pharmaceutical and Biologic Companies training seminars presented by ComplianceOnline register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

US GCP Fundamentals for Pharmaceutical and Biologic Companies  

 Email information about this seminar US GCP Fundamentals for Pharmaceutical and Biologic Companies by ComplianceOnline to yourself your manager or associates Email this event... View and register for other training seminars like US GCP Fundamentals for Pharmaceutical and Biologic Companies by ComplianceOnline on FindaSeminar.com Find similar training.. Find and register for other training seminars by ComplianceOnline on FindaSeminar.com Other seminars from ComplianceOnline

By:

training seminars by ComplianceOnline ComplianceOnline   

For:

This course is designed for people tasked with managing or overseeing clinical trial operations and quality assurance, or for hosting FDA inspections in the GCP (Bioresearch Monitoring, “Bi-Mo” area).

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

This seminar provides an introduction to GCP, with emphasis on the regulations governing drug and biologic clinical trials. (Most of the information is also applicable to medical devices, but specific requirements for device trials are not discussed.) (see full course description)

 

 Seminar / Training class dates & locations

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

FDA+GCP+inspections+good+clinical+practices+compliance+trial+sites+IBRs+manufacturing+GMP+inspection+ICH+guidelines training seminars workshops conferences online training

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search

NEW  Don't miss training you want to attend

Receive a personal Training Alert when training you want to attend comes to your area. Create a personal Training Alert now  it's Free and only takes a minute!


 

 

 

share this page 

print the agenda print agenda for the US GCP Fundamentals for Pharmaceutical and Biologic Companies seminar

 

 

Training Course Syllabus:


US GCP Fundamentals for Pharmaceutical and Biologic Companies

Good Clinical Practice (GCP) is a term used to describe a collection of various FDA regulations that govern the conduct of clinical trials. It includes regulations which apply to Sponsors and Contract Research Organizations (CROs) who run the trials, the clinical trial sites and Investigators who conduct the research, the Institutional Review Boards ("IRBs" or Ethics Committees) who oversee the conduct of the trials, and includes other aspects such as avoidance of financial conflict of interest on the part of clinical investigators. The FDA conducts inspections at all of these levels to determine if there has been compliance with GCP, and if not, the agency may take any of a variety of enforcement actions

This seminar provides an introduction to GCP, with emphasis on the regulations governing drug and biologic clinical trials. (Most of the information is also applicable to medical devices, but specific requirements for device trials are not discussed.) It also covers the essential elements of FDA inspections of Sponsors and CROs, clinical trial sites, and IRBs, provides guidance for how to effectively prepare for and manage these inspections, and how to communicate effectively with the FDA about inspection outcomes.

Since many companies operate clinical trials in a variety of world-wide venues, the course provides an introduction to key guidelines for GCP from the International Conference on Harmonization (ICH), which are used by multiple health regulatory authorities as definitive guidance for GCP compliance. The primary emphasis, however, is placed on FDA requirements.

Learning Objectives:

Upon completing this course participants should:

Understand the meaning of the term “Good Clinical Practice” (GCP)

Know which FDA regulations constitute GCP

Know the requirements the regulations place on Sponsors, CROs, clinical trial sites and IRBs

Understand the basic elements of informed consent

Understand the rules for avoidance of financial conflict of interest by clinical investigators

Understand the applicability of Good Manufacturing Practice to the production of clinical trial materials

Understand why inventory control and reconciliation is important to GCP compliance

Understand the criticality of data integrity and the prevention and detection of fraud and misconduct in clinical trials

Understand the basics of FDA inspection management, and how to find key guidance resources to prepare for and manage FDA GCP inspections

Understand the role of ICH guidelines in GCP compliance


Day 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

Introduction of Instructor and participants; participants share their objectives for the training session

Topic Introduction – Good Clinical Practices (Pharmaceuticals)

Responsibilities of Sponsors – Overview – 21 CFR Part 312

Listing of trials on clinicaltrials.gov

Lunch – mid day – 1 hour

Informed consent process – 21 CFR Part 50

Role of Institutional Review Boards (aka Ethics Committees) – 21 CFR Part 56

Investigator (site) responsibilities –

Wrap up for the day and Q&A


Day 02(8:30 AM - 3:15 PM)

Drug safety monitoring and reporting requirements

Investigational product issues

Data integrity and 21 CFR Part 11 (electronic document/electronic signature rule)

Overview of the FDA inspection and enforcement process

Lunch Break

Review objectives set on day one; assess progress; address any issues not yet covered

Final discussion and Q&A

End approx.. 3:00 PM

Seminar Summary:

This seminar provides an introduction to GCP, with emphasis on the regulations governing drug and biologic clinical trials. (Most of the information is also applicable to medical devices, but specific requirements for device trials are not discussed.) (see full course description)

print this agenda print agenda for the US GCP Fundamentals for Pharmaceutical and Biologic Companies training seminar

 view dates and locations for this seminar

 

 

 

Custom Search