Creating Compliant Communications and Documentation Training

Pharmaceutical companies know the importance of compliant practices for mitigating risks and maintaining a positive reputation. Code of conduct guidelines, handbooks, and training on compliant behavior exist in most organizations, especially for sales, managed markets, and/or medical interactions with external customers. However, there is usually less guidance provided for employees on how to communicate and document in a compliant fashion.

This guidance is critical for two (2) reasons:

  1. Good communication is a critical business need. It is essential for individuals to share objectives and information within the company, as well as with external customers. The more effectively your employees can communicate, the more value they provide to the company.
  2. Poor communication and documentation can place the company in jeopardy – it carries the same business risks as poor conduct.  All written communication and company documents, for example, about product information, customer interactions, or internal procedures are discoverable.  Improper communication and poor  documentation can result in misunderstandings and may be used to support claims against the company.

Pharmaceutical companies should ensure that employees are knowledgeable and can use compliant communication and documentation practices to perform effectively and keep themselves and the organization in safe harbor.

Best practices for creating effective communication and documentation training include:

  • Determine key areas of risk with an assessment that includes a variety of roles to establish “hot topics.” Training should be provided to everyone in the company and cover all forms of communication and documentation (e.g., email, texts, call notes, coaching forms, business plans, and reports); however, there may be a few types of communication or particular roles that require extra attention.
  • Be explicit about expectations for good communication and documentation. Customize training for different groups by providing specific examples of what to avoid, best practices, and “grey areas” for group discussion and learning. Also, make sure you are enabling good practices by including what they “can” say; not paralyzing by only telling them what they “cannot” say.
  • Cascade the training throughout the organization with a leader-led approach to demonstrate leadership endorsement.  When leaders and managers reinforce the importance of the topic, employees are more likely to pay attention and apply what they learned.
  • Include live workshops (where feasible) to provide opportunities for discussion, behavioral practice, and feedback. The opportunity to observe and model behavior greatly enhances the chances that the training will be remembered and that behavior change will occur.
  • Monitor communication, documentation, and create a closed loop reporting system. Ongoing monitoring helps convey that good communication and documentation are an ongoing expectation. A closed loop reporting system ensures there is follow-up on any potential compliance issues and demonstrates a proactive commitment to compliance.

Wendy L. Heckelman
Author:
Wendy L. Heckelman

Dr. Wendy Heckelman, president and founder of WLH Consulting, Inc. has 25 years of experience working with Fortune 100 industry clients. These include pharmaceutical, biotech, health care, consumer products, financial services, and distribution service organizations. Wendy has also worked with international non-profit organizations and growing entrepreneurial companies.

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