Training employees, executives and business leaders, who work in the healthcare industry, on compliance issues is an especially challenging task. That’s because of a cross-section of stakeholders and regulatory bodies impacted by or involved in compliance. Some of these include:

  • Shareholders
  • Investors
  • Manufacturing partners
  • Consumer Product Safety Commission (CPSC)
  • Drug Enforcement Administration (DEA)
  • Environmental Protection Agency (EPA)
  • Federal Trade Commission (FTC)
  • Food and Drug Administration (FDA)
  • Occupational Safety and Health Admin (OSHA)

Additionally, both drug manufacturers – through the Food Safety Modernization Act (FSMA) – and device manufacturers – through the FDA’s Center for Devices and Radiological Health (CDRH), are subject to a wide range of continually updated and evolving compliance mandates. Creating training content in such an environment can be difficult. However, instructional designers and course developers may benefit if they use a building block approach to compliance training development.

Compliance training building blocks

The heart of any compliance training program, for medical device and pharmaceutical product manufacturers, must revolve around the creation and implementation of strong corrective and preventive actions (CAPA) systems and processes. When creating relevant compliance training content around CAPA, instructional designers must focus their attention on two distinct areas of compliance:

  • Short-term solutions: This content will teach staff how to take immediate corrective action to resolve a non-compliant situation
  • Long-term approach: Which must educate/train staff on how to develop and implement strategies and processes to reduce, and ideally eliminate, the occurrence of non-complying incidents. This type of content is preventative in nature

Any instructional content produced under these two streams must include concrete steps on how to enhance product quality, reduce or eliminate manufacturing problems, and address customer and regulatory body complaints. Included within this framework of training should also be strategies and approaches to identify and mitigate any risks, investigate and analyze noncompliance, determine the root cause of such instances, and report and document all findings throughout the process.

Core training highlights

Training pharma and device manufacturer staff to be compliant in today’s regulatory-heavy environment requires instructional designers to develop a curriculum that’s broader than Good “x” Practices (GxP) – where “x” = Manufacturing, Clinical, Laboratory, Storage or Distribution. The ultimate objective of any compliance training must be to empower pharma and device manufacturing industry staff to produce high-quality, safe and fully compliant drugs and devices. Here are some of the highlights of areas that your training curriculum must cover:

  • Quality training: A key module in any compliance training must be the company’s Quality Control (QC) and Quality Assurance (QA) systems. When any non-compliance issue arises, the first thing that regulators like the CPSC, FDA, DEA, and OSHA look into is internal QC/QA processes. Your content must cover mapping, documenting and understanding these processes
  • Roles & Responsibilities training: Like many other industries, healthcare manufacturing businesses, whether drugs or devices are susceptible to staffing changes. It is imperative that you develop training content, for key staff responsible for compliance, on all aspects of their roles and responsibilities. Additionally, it is vital to train senior staff, such as Chief Compliance Officer (CCO), on all functional areas impacting compliance
  • Operational training: This type of compliance-related training content must aim to prepare staff to deal with operational challenges that either lead to non-compliance or are a result of non-compliance. Your curriculum must include topics such as:
    • Developing policies, procedures and processes to capture product issue reports
    • Documenting customer complaints
    • Recording product returns
    • Tracking samples (of raw materials, finished goods, demo devices, etc.)
    • Logging significant contacts between company staff and external partners/stakeholders (Physicians, Doctors, Hospital Administrators, Healthcare facility owners, Distributors, Suppliers, etc.)
    • Maintaining journals of important marketing activities, such as promotions, discounts, subsidy programs, sponsorships, etc.

While compliance impacts every aspect of a pharmaceutical company or device manufacturer, from receiving and shipping, to product research and development and marketing, training content must pay special emphasis to staff whose primary function is to deal with proactive or reactive compliance issues. Here are some core training subjects that you should include in your compliance training curriculum:

  • Product Complaints: One of the most common ways through which regulators become aware of compliance infringements is through product complaints. The Consumer Product Safety Act (CPSA) – for device manufacturers – and Food and Drugs Act (FDA) – for pharmaceuticals and drugs – stipulate how such eventualities must be dealt with. It is essential that compliance training focuses on how front-line staff handle product complaints and recalls in-line with CPSA and FDA. Subject matter covered must include both mandatory and voluntary recalls.
  • Protocol Deviation: Once companies establish compliance protocols, they must be strictly adhered to. However, deviations may:
    • occur due to unintentional oversight
    • come to light in hindsight
    • take place intentionally to deliberately deceive management or regulators

Training content must include all aspects of protocol non-compliance, including lack of adherence, deviations, violation, variances, and departure.

  • Root Cause Analysis (RCA): When it comes to investigating and analyzing the causes of nonconformance, noncompliance or deviation from specifications, both drug manufacturers and device makers can leverage Root Cause Analysis (RCA) tools to their advantage. Part of your training content, related to RCA, must include:
    • Process diagrams and flow charts
    • Cause and Effect Diagrams (Fishbone charts)
    • Data analysis techniques, such as frequency data, log analysis and timeline examination
    • Interviewing techniques
    • Communication methods – presentations, charts, tables, and report-writing

As you develop your content, make sure you review regulations 21 CFR 211.192 (for drugs) and 21 CFR 820.100 (devices) and include content that facilitates compliance with them.

  • Risk Management: One important consideration for Instructional designers to keep front and center, when developing healthcare-related compliance content, is about the risks that a pharma product producer or device manufacturing company must manage. While compliance risks may typically emanate from within an organization, business leaders and executives must also learn how to identify, mitigate and manage external risks too.

Your training content must also deal with risk management topics related to:

    • Working under Corporate Integrity Agreement (CIA) relationships
    • Partnering with external Health Care Providers (HCPs)
    • Interactions of the organization’s HCPs with other agencies/entities on their (the organizations’) behalf, including physicians, hospital administrators, and prospective clients

Compliance training must not only focus on drug and device manufacturing risks but also risks associated with sales, marketing, and information dissemination activities – both internally and by outsourced agents of the company.

Compliance is never static

Developing content for training healthcare professionals to be compliant requires a disciplined approach:

  • Determine what regulatory and compliance environment the client is subject to
  • Understand how those compliance directives apply to client-specific requirements
  • Create content that addresses those requirements

The greatest challenge for instructional designers of healthcare-related compliance content, however, is that the rules and regulations around compliance are continually evolving. As a result, so should your content. One resource that you could lean into is the Electronic Code of Federal Regulations (e-CFR), which is an online, easily navigable online database that provides you up-to-date versions of all codes and regulations emanating from the FDA and DEA.