Companion Inspection

Inspection Readiness Training Events

What we are providing

CRP Ally believes that federal inspections are the price of success! In fact, anyone that takes medicine or uses a medical device would want to know the research done was completed accurately and with integrity. Therefore, if you're engaged in clinical research that is likely to be FDA inspected or just want to have a better understanding of the FDA inspection process; this event is for you. This event is entirely focused on FDA inspections, what to expect, how to prepare, and considerations to ensure your research is "5-day ready."


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; Inspection Readiness According to Appropriate Compliance Program Documents; and more...

Reduce

Stress

Enhance

Expertise

Become

"5-Day Ready"

Build

Confidence

This event is ideal for:

  • Anyone wanting to learn more about FDA's inspection process of "Sponsor-Investigators" or "Investigator" sites
  • Investigators and Sponsor-Investigators
  • Clinical Research Coordinators
  • Clinical Research Nurses
  • Regulatory Coordinators
  • Clinical Research Assistants
  • Clinical Research Supervisors, Managers, or other Leadership
  • Clinical Research Quality Assurance Specialists
  • Teams expecting FDA inspections for Clinical Research
  • Teams building new Clinical Research Programs

The Process is SIMPLE:

  1. Contact us to discuss your site's inspection readiness training needs.
  2. We'll prepare a customized training event agenda highlighting your special needs for your review.
  3. Schedule your event (NOTE: deposit to hold dates with minimum event attendance required).
  4. Three weeks prior to event provide CRP Ally with the event's attendee list & contact information.
  5. Enjoy the Event!
  6. 1-month following the event you will receive a comprehensive report on the training items, discussion material, and other useful documentation.

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)
  • FDA Inspection Reference Resources
  • Brief skills assessment
  • 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
  • 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"
Discuss 5-day readiness

Dedicated time for discussion of inspection preparedness:

  • Culture and inspection preparedness
  • Inspection walkthrough with real-world inspection examples and anecdotes 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
  • Preparation, coordination, and professional execution of your inspection readiness plan
  • Documenting the inspection
  • After the inspection
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 group's next steps in inspection preparedness
  • 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. 

Contact Us & Let Us Know How We Can Help You

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