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.
Incorporating the updates in ICH E6 R2, we will discuss how clinical research team
members can implement systems to manage quality throughout the trial 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
- Describe the elements of functional Quality
Systems for Sponsors, Institutional Review Boards(IRBs), and Clinical
- Identify the universal and local
components of GCP
- Explain the differences between the
legal and procedural elements of GCP
- Describe the overlap between GCP and
Good Manufacturing Practice (GMP)
- Recognize key differences in
pharmaceutical, device, and biologics GCP
- Examine recent trends in
- Develop and implement site-specific
approaches for corrective action of non-compliance
- 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
Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
Elizabeth Ronk Nelson,
Lily Romero, P.A., C.C.R.C.
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Day One: 8:30 a.m. – 5:00 p.m.
- Principles of GCP: Different Perspectives: Examination; application; implementation
- New Developments and Emerging Trends in GCP
- The “Forgotten” Elements of GCP: Regulations; laws; guidelines
- Quality Systems: The Roadmap to GCP: Quality control; quality assurance; quality
Two: 8:30 a.m. – 5:00 p.m.
- Quality Risk Management (QRM) in Clinical Trials: Application of risk assessment in the review of
- The Role of Standard Operating Procedures in GCP: Rationale; development; training; implementation;
- GCP Across Investigational Products: Drugs; devices; biologics
- Are We There Yet? Recent non-compliance issues with discussion of
Corrective and Preventive Action planning
- Document Reviews
- Mock Audit/Inspection Exercise
- Case Study Scenario Problem Solving
- Group Discussions of Best
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.
Click here for our seminar
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
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-18-030-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1