Building Confidence in Compliance
Training Events
What we are providing
Clinical research is complex with many stakeholders, regulatory requirements, and operational considerations. In our experience, compliance issues are most often the result of a breakdown in standard operations, lack of specific processes, overwhelmed systems, or individuals doing work that they have insufficient training in. We believe compliance concerns, quality control, and quality assurance should focus on systems, operations, and standards. Therefore, this in-person training event focuses on helping teams, and programs, align on the critical requirements for conducting clinical research including "how" to maintain the level of quality, scientific integrity, and Protection of Human Subjects that is required. We leverage real-life examples, and experiences, to support attendees work through quality issues and audit, or inspection, preparedness.
This seminar covers: Regulatory Framework & Background within the United States; The FDA's Drug and Device Approval Process; Laws, Regulations, Good Clinical Practice, and Other Guidance; Policies, Standard Operating Procedures (SOPs), and Manual of Operating Procedures (MOPs); Essential Documentation; Good Documentation Practice and Source Materials; Corrective and Preventive Actions (CAPA); Quality Assurance; Audit and Inspection Readiness; Balancing Efficiency & Quality while Never Compromising Scientific Integrity and Protection of Human Subjects; and more...
Enhance
Expertise
Build
Confidence
Build Culture
of Compliance
Improve
Quality
This training event is ideal for:
- Anyone wanting to learn more about "sponsor-investigator" or "investigator" team compliance for FDA regulated clinical research.
- Clinical Research Coordinators
- Clinical Research Nurses
- Regulatory Coordinators
- Clinical Research Assistants
- Clinical Research Supervisors, Managers, or other Leadership
- Clinical Research Quality Assurance Specialists
- Teams responding to Compliance Concerns or Issues
- Teams building new Clinical Research Programs
The Process is SIMPLE:
- Contact us to discuss your site's compliance related training needs.
- We'll prepare a customized training event agenda highlighting your special needs for your review.
- Schedule your event (NOTE: deposit to hold dates with minimum event attendance required).
- Three weeks prior to event provide CRP Ally with the event's attendee list & contact information.
- Enjoy the Event!
- 1-month following the event you will receive a comprehensive report on the event
What attendees can expect.
Two weeks before event
Attendees receive the pre-event materials via email including:
- Welcome letter
- What to expect with details (e.g., time & location)
- Brief skills assessment
- Brief compliance questionnaire
- Request for individuals' professional goal & hopes for event experience
Event Day 1: Welcome
Every event starts with:
- Welcome & education materials packet
- Introductions
- Establishing group expectations, hopes, concerns, and norms to be used throughout the event
- Identify groups' compliance questions, issues, and goals
- Creation of event "Parking Lot Follow-Up" where we'll track tangential, but important questions throughout the event
Event material discourse
Foundational material is presented and discussed leveraging:
- Real-world examples and anecdotes
- References to source laws, regulations, and guidance materials
- Attendees' current experiences, challenges & opportunities
- Any important, tangential questions that cannot be answered immediately will be logged in the event's "Parking Lot Follow-Up"
Digging deep on compliance and corrective action
Dedicated time for discussion of goals:
- Culture and compliance
- Real-world examples from multiple perspectives.
- Leveraging systems, SOPs, and MOPs
- Good documentation practice
- Source materials and real-world examples of best practices & worst practices
- Timely communication and transparency
- Making sustainable effective change and CAPAs
- The value of internal quality reviews
End of event wrap-up
All events end with:
- Review of established group hopes and expectations
- Review of professional goal in-line with learnings.
- Review of groups' compliance questions, issues, and goals for the event.
- Review of event's "Parking Lot Follow-up" for comprehensiveness and accuracy
- Quick event experience survey
1-Month post event follow-up
Attendees receive post event materials via email including:
- Event report-out containing event's expectations, hopes, concerns, norms, references, resources, and responses to "Parking Lot Follow-up"
- CRP Companion Individualized Professional Development Report with personalized feedback and opportunities for continued professional development.
Our Guarantee
If our materials change after your event, YOU get the update free!
If we make changes to the training packet that attendees receive after your event, then we will send every attendee a free e-copy of the updated version. You don't need to do anything. We'll send the update automatically to registered event attendees. This guarantee is good for up to 1-year after the day of your event.