This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This program is designed for professionals with at least two years of experience in the clinical research industry.
- Develop and implement site-specific approaches for corrective action of non-compliance
- Describe the elements of a functional Quality System
- Define key GCP terms
- Examine recent trends in non-compliance
- Identify the universal and local components of GCP
- Explain the differences between the legal and procedural elements of GCP
- Recognize key differences in pharmaceutical, device, and biologics GCP
- Describe the overlap between GCP and GMP
This course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP-Focused Regulatory Affairs Professionals.
The course will be led by one of the following instructors:
Elizabeth Ronk Nelson, M.P.H.
Lily Romero, P.A., C.C.R.C.
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Day One: 8:30 a.m. – 5:00 p.m.
- GCP Terminology: Beyond the ABCs
- New Developments and Emerging Trends in GCP
- Principles of GCP: Different Perspectives: Examination; application; implementation
- The “Forgotten” Elements of GCP: Regulations; laws; guidelines
Day Two: 8:30 a.m. – 5:00 p.m.
- Quality Systems: The Roadmap to GCP: Quality control; quality assurance; quality improvement
- The Role of Standard Operating Procedures in GCP: Rationale; development; training; implementation; maintenance
- GCP Across Investigational Products: Drugs; devices; biologics
- Are We There Yet?: Recent non-compliance issues with discussion
There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.
- Document Reviews
- Mock Audit/Inspection Exercise
- Case Study Scenario Problem Solving
- Group Discussions of Best Practices
Registration 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 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-38-L01-P. Released 9/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.