Developing Auditing/Monitoring Plans and Checklists

Developing Auditing/Monitoring Plans and Checklists to Collect Data That is Helpful for Both Compliance and the Business

Sharon R. Delshad

Founder, Rebel Compliance

July 14th, 2021

2:00 PM – 3:00 PM EDT

Earn CLE credits*
(*pending final approval)

Auditing and monitoring are critical elements of a Compliance Program that help us check whether Compliance requirements are being met. They also provide an opportunity to provide both Compliance and Business insights so that we can continuously improve our business processes and reduce risks. In this webinar, we will discuss the elements of an auditing and monitoring plan to test high risk business activities. We will also demonstrate how to create auditing and monitoring checklists that are both simple and thorough in order to collect data. Finally, we will review tips to collate the data collected to provide reports that are useful to Compliance and the Business.

Our Learning Goals:

  • How to identify business activities to monitor or audit for healthcare compliance
  • Tips on how to keep the Business informed of monitoring and auditing plans
  • The preliminary information that should be included in checklists
  • How to identify what is testable from a policy or procedure
  • How to create testing questions
  • Whether to have open text sections in a monitoring/auditing checklist
  • Determining what non-Compliance information can also be included in a checklist
  • Partnering with commercial operations and spend transparency teams to automate audits
  • Tips on how to estimate how long an audit may take
  • Discuss what can be outsourced and best practices for outsourcing monitoring
  • Reporting tools and systems to help collate information to ease and streamline reporting

Earn CLE credits*
(*pending final approval)


SPEAKERS


Sharon R. Delshad

Founder, Rebel Compliance


Sharon is a compliance consultant with over 10 years experience supporting life sciences companies as both an in-house Compliance Director and Big 4 consultant with EY and PwC. She is a compliance generalist who has worked in depth on all aspects of Healthcare Compliance (e.g., “The 7 Elements of an Effective Compliance Program,” spend transparency, privacy, enterprise compliance). Sharon is currently advising a pre-launch pharmaceutical client on developing its Compliance Program and project managing a 2-year workplan developed based on an assessment she conducted for the

company. In her in-house pharma/biotech positions, Sharon assisted in building and managing Compliance Programs, including full responsibility for Compliance Operations at Nalpropion Pharmaceuticals.