FCPA and Rx&D ! Compliance Direct Support System! Performance Improvement Case Study
Jessica Haak Interactivity Specialist
Ultimate ! Sustainability Goal:! Ensure 100% compliance with FCPA & Rx&D regulations as they are updated!
Road Map! C B A eLearning Compliance Program
Train
Compliance Direct Support System
Support
Internal Ad Campaign
Promote
Sustainability! Ensure 100% compliance with the ! FCPA and Rx&D regulations as they are updated !
Change Management! Active Communication! Cooperation of Multiple Departments!
Current Performance!
Performer Level
Environmental Level
Environmental Survey !
Difficulty when venturing into grey territory
Should offer easy access to regulations when performers need them
May be hesitant to ask important questions
Should have punitive checks & balances in the system that prevent egregious disrespect for the rules
Performer Level
Environmental Level
Objectives!
1
Recognize situations that are potential violations
2
Access company support when rules are unclear
How do we get there?!
Approach! Interface Leverage the functionality of your current LMS. Content Strategy Have a communication & change management plan that will provide a sustainable content maintenance system as regulations change. User Strategy Ensure users are able to find all of the available resources in a timely fashion.
What your LMS ! can do already‌! Automate Messages Send Alerts Host FAQs Author Branching Support Offer Real-Time Chat Support Provide Periodic Testing iPad compatible Store Data Secure Information
LMS Content Design ! Welcome News FAQs Scenarios Guides
Up-to-date compliance information Content verified by the legal department Branching activities in the scenarios section that guide performers Easy access to compliance documents
Compliance Chat Contact Us
Online Content
Regular Compliance Chat events where performers can speak with compliance officers
LMS Content Design ! Training Dates Chat Sessions Compliance Promotion Recent Infractions Events Warnings Alerts
Targeted notices Can be sent to company email or to mobile devices Particularly useful for training reminders, chat session reminders, and promotion of the support system and a compliance culture. We will create easy to update templates for sustainability of the alerts. Valuable when high risk violation events are approaching.
1:30pm!
Compliance Chat Tomorrow From 9am-12pm
1:30pm!
compliancedirect@schmidpharmaceuticals marc.smith@schmidpharmaceuticals
Compliance Direct Chat
Compliance Direct Update! As you may know this week Company X was forced to pay $30 million in penalties after they inappropriately entertained officials in Country Y and violated FCPA regulations. For more examples of recent violations please visit: http://www.sec.gov/spotlight/fcpa/fcpa-cases.shtml Please note that with Fundraiser A rapidly approaching and many foreign guests on the list we have set up our Compliance Direct Chat service on‌ Monday June 17th & Thursday June 20th from 9:00-12:00am A compliance officer will be available to answer an all questions and will be expecting to hear a report from all relevant teams about measures they have taken to prevent FCPA violations.
LMS Content ! Information on individual and group performance Analytics
Individual Metrics Time spent on the system Chat conversation transcripts Red flagged conversations Quiz scores Group Metrics Usage by department Aggregated chat content # of red flags Aggregated quiz scores Easy to generate reports that can be used to measure the success of the intervention & to provide data to HR.
Compliance Direct Support System ! Log In
Online ! Training!
Enter your Compliance elearning Course!
Enter your Compliance Direct Support System !
username
username
password
password
Sign In
Sign In
Compliance Direct Support System ! Welcome News Frequently Asked Questions Scenarios Guides Compliance Chat Quizzes Contact Us
Welcome The Compliance Direct Support System is here to help ensure that we are in total compliance with the FCPA and Rx&D regulations. Protect yourself! Every year billions of dollars worth of fines are handed down for compliance-based infractions in our industry. These infractions are 100% preventable and require due diligence by all members of our company. For this reason we have worked closely with our legal department to give you accurate information and resources to recognize conflict of interest before they happen.
Compliance Direct Support System ! Welcome News Frequently Asked Questions Scenarios Guides Compliance Chat Quizzes Contact Us
May 29, 2013 Total S.A. was recently fined $398 million dollars for bribery and violation of the FCPA regulations. May 15, 2013 Compliance Chat will be up and running this week on Monday June 17th and Thursday June 20th from 9:00am to 12:00pm. Please access the service when you prepare to book your event lists for the upcoming fundraiser. All participating departments must check-in to this event and confirm the measures they have taken to prevent FCPA violations to their Compliance Chat officer.
Compliance Direct Support System ! Welcome News Frequently Asked Questions Scenarios Guides Compliance Chat Quizzes Contact Us
Q! A!
What is the difference between the FCPA & the Rx&D? The Rx&D is a Canadian code that has been in existence since 1988. This code applies to ethical conduct of employees in the pharmaceutical field. The FCPA is an American-led Act that includes antibribery measures and appropriate accounting practices to support it. There is overlap between the ideals of the Rx&D and the FCPA and all employees at Schmid Pharamaceuticals must be in total compliance with both.
Compliance Direct Support System ! Welcome News Frequently Asked Questions Scenarios Guides Compliance Chat Quizzes Contact Us
Scenarios  Planning a trip? Setting up a meeting? Claiming expenses? Promoting a product? Interacting with scientists?
Compliance Direct Support System ! Welcome News Frequently Asked Questions Scenarios Guides Compliance Chat Quizzes Contact Us
FCPA elearning Training Manual
Rx&D elearning Training Manual
Compliance Direct Support System ! Welcome News Frequently Asked Questions Scenarios Guides Compliance Chat Quizzes Contact Us
Jim Baker Compliance Officer How can I help you today?
Jessica Haak VP of Marketing I am unclear about how to best comply with FCPA regulations on working with charitable organizations that have links to event attendees, could you please clarify what is permissible in terms of guest lists when‌
Compliance Direct Support System ! Welcome News Frequently Asked Questions
Protect Yourself The best way to protect yourself is to be informed. Test your knowledge below.
Scenarios Guides Compliance Chat Quizzes Contact Us
FCPA Protect Yourself Quiz Question 1 ! What does “corruptly” mean within the FCPA?
Rx&D Protect Yourself Quiz Question 1 ! Which of these practices is appropriate when scheduling a business meeting?
Compliance Direct Support System ! Welcome News Frequently Asked Questions Scenarios
Get in Touch Always air on the side of caution when it comes to compliance issues. Our compliance officers are happy to discuss any regulations that you are having difficulty with. Below is a directory.
Guides Compliance Chat
Jim Baker Compliance Officer
Quizzes Contact Us
Office: LB 540 Telephone: 514.555.5555 Email: jimbaker@schmidpharmaceuticals
Who is responsible for updates?!
Responsibility by Department ! LEGAL!
TRAINING!
HR!
Notify training department of any changes to FCPA or Rx&D
Design & develop content update strategies
Track performance metrics
Provide Compliance Chat on an on-going basis
Plan Compliance Chat events
Schedule retraining events
Flag users who ask suspicious questions & send content to HR Sign off on content updates
Conduct biyearly analysis of program Maintain project documents
IT! Maintain LMS Update LMS content Comply with FCPA LMS requirements
Important ! LMS Considerations! Title 21 CFR Part 11of the Code of Federal Regulations Installation Qualification Operational Qualification Performance Qualification Regular audits of our LMS system
Meeting Schedule ! No Changes: Meeting schedule is every month. Changes: Training department will prepare a strategy to be presented to other departments. Change Transition: Bimonthly meetings unless otherwise suggested by the project sponsor.