What is in this article?:
- What Pharma Planners Need to Know to Be Audit-Ready
- Anatomy of an Audit
- Four Stages of Risk
- Helpful Audit Prep Hints
Audit prep expert Lisa Keilty, CMP, HCC, president /owner of the pharma compliance consulting firm PMC2 (Professional Meeting Compliance Connection), explored what the OIG is looking for, and how pharma planners can prepare for an audit, during a session on audit preparation and standard operating procedures at the 2013 Pharma Forum in Orlando.
Helpful Audit Prep Hints
• Understand why something is expected of you—it makes the task easier and will improve your communication with an auditor and other stakeholders.
• Document, document, document—take notes immediately and use a date and time stamp. Keep them simple and to the point. Tell the story.
• If you have an intuition that something is not right, follow up. Stamp the information with the date and time and save it with the rest of your documentation.
• Be proactive, not reactive.
• Educate your:
-meeting host/project team
-country office contact
-vendors (hotels, third-party planners, content vendors, etc.)
-attendees—let them know what is and is not acceptable, and what will expedite reimbursement and minimize consequences.
• Automate as much as possible. Auditors like systems to tell the story instead of hand-written notes, so use time stamps and find ways to automate matching your attendee list to the sign-in sheet if you can.
• Have a clean, accessible system for storing information that you can access quickly and easily.
• Don’t forget to follow through when deviations occur.
• Know who your company defines as an HCP—is it just MDs, or all the way down the line?
• Ask the hotel to provide detailed billing so auditors don’t have to come back for more on specific items.
• Train everyone who touches that meeting, including trip directors. Let them know what you need them to do if a deviation happens. It’s best to document as it happens so you don’t have to go back later and try to recreate the situation.