Advanced Good Clinical Practice: Practical Application and Implementation

Course Description

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. 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 research industry.

Learning Objectives

• Describe the elements of functional Quality Systems for Sponsors, Institutional Review Boards (IRBs), and Clinical Investigators
• 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 non-compliance
• Develop and implement site-specific approaches for corrective action of non-compliance

Who Should Attend

• This course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP Focused Regulatory Affairs Professionals.

Instructor

The course will be led by one of the following instructors:

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM, P.M.P.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Elizabeth Ronk Nelson, M.P.H.

Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies

Course Outline

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 improvement

Day Two: 8:30 a.m. – 5:00 p.m.

• Quality Risk Management (QRM) in Clinical Trials: Application of risk assessment in the review of protocols
• 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 of Corrective and Preventive Action planning

Interactive Activities

• Document Reviews
• Mock Audit/Inspection Exercise
• Case Study Scenario Problem Solving
• Group Discussions of Best Practices

Registration Fees

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.     

Click here for our seminar cancellation policy

Accreditation Information

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. Released: 10/18.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.