Compliance Training and Development

In practice, I often encounter situations where Compliance programs focus primarily on POLICIES, PROCEDURES, AND CONTROLS, but the real risk does not lie only in documents—it lies in people who do not understand them or are unaware of their importance. 💡 An employee who is neither informed nor trained represents a serious risk to the organization. WHY? Lack of knowledge does not exempt one from responsibility. Employees who are unaware of the rules may unintentionally violate the law, damage the organization's reputation, or create financial and regulatory risks. What can be done? 1.     TRAINING, TRAINING, TRAINING! The only way to reduce this risk is through continuous employee education. Compliance is not something you learn once and forget—regulations, trends, and stakeholder expectations constantly evolve, and awareness of risks must be regularly updated. When I talk about training, I don’t mean just basic Compliance sessions on the Code of Ethics and internal policies. There is a whole range of critical topics that employees need to understand to navigate Compliance & Ethics effectively. 2. CLEAR AND STRATEGIC COMMUNICATION Beyond formal training, the key to success lies in clear, two-way, and easily understandable communication. If employees don’t know where to find key information, seek advice, or report irregularities, and if internal policies are written in complex legal language, their practical application will be minimal. When I talk about communication, I don’t just mean internal communication within the organization but also how Compliance is communicated to third parties, the public, and the media. How does your organization approach this? According to research conducted in the region where I work, only 22% of organizations conduct Compliance & Ethics training once a year. 📌 Compliance is not just an internal process—it is the foundation of corporate reputation. #compliance #training

RESPECT AT WORK | Compliance-based harassment, bullying and discrimination training typically involves defining and providing examples of prohibited potential unlawful and criminal behaviours. Not surprisingly, while this approach transfers knowledge, it does little to prevent those behaviours. Many participants fail to connect cognitively or emotionally with the content because they don't feel it's relevant to their behaviour or their experience. Other participants feel powerless to effect change in others' behaviours. Also, we know that learning and behavioural change are more likely when individuals feel they are part of the solution and not the problem—telling learners what they can do rather than what they can't. Effective respectful workplace behaviour training focuses on the underlying stereotypes and biases that devalue some individuals and groups relative to others and transfers skills for identifying and disrupting harmful beliefs whether they manifest as unconscious biases, casual sexism and racism, subtle slights of exclusion, or prohibited behaviours. While not all employees will experience or witness unlawful and criminal behaviours at work, most employees experience or witness everyday biases. When these lower-level harms are left unchecked, the harmful stereotypes and beliefs that underpin them are perpetuated. These are the same beliefs and attitudes that underpin more serious harm. The negative stereotypes that devalue women, diverse genders, or diverse sexualities that underpin a sexist or homophobic joke are the same negative stereotypes that underpin gendered and sexual violence. When employees are empowered to disrupt everyday biases, they become powerful change agents for preventing more serious harm. We support employers in preventing workplace misconduct through workplace culture reviews, risk assessment, learning and development, and employee focus groups. Email info@cultureplusconsulting.com for further information. Additional resources: Why employers need to step up: https://lnkd.in/gkNg_46R A checklist for boards: https://lnkd.in/gP8TMBzX Leadership considerations: https://lnkd.in/gFB7CvDe Identifying risks: https://lnkd.in/gvVYrDUy Managing risks: https://lnkd.in/gKSpxQu5 Evidence-based training: https://lnkd.in/gUN8cwTd and https://lnkd.in/gFB7CvDe Trauma-informed grievance processes: https://lnkd.in/gP5Z5pcc

𝗪𝗵𝗼 𝗶𝗻 𝘆𝗼𝘂𝗿 𝗰𝗼𝗺𝗽𝗮𝗻𝘆 𝘀𝗵𝗼𝘂𝗹𝗱 𝗹𝗲𝗮𝗿𝗻 𝘁𝗵𝗲 𝗯𝗮𝘀𝗶𝗰𝘀 𝗼𝗳 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 (𝗥𝗔)? Regulatory Affairs isn’t just for RA teams, but it’s the backbone of compliance, product safety, and market success. Many departments can benefit from understanding the basics of RA. Here’s how RA basics can help each team: 1️⃣ 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 & 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 (𝗥&𝗗) 𝗪𝗵𝗮𝘁 𝘁𝗵𝗲𝘆 𝗰𝗮𝗻 𝗹𝗲𝗮𝗿𝗻:   - Regulatory pathways for product approval.   - Data requirements for technical files or dossiers.    𝗜𝗺𝗽𝗮𝗰𝘁: Products are designed and tested with compliance in mind, avoiding costly rework or missed timelines. 2️⃣ 𝗣𝗿𝗼𝗱𝗰𝘂𝘁𝗶𝗼𝗻/𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗪𝗵𝗮𝘁 𝘁𝗵𝗲𝘆 𝗰𝗮𝗻 𝗹𝗲𝗮𝗿𝗻:   - Regulatory requirements for labeling, batch traceability, and process validations.   - Change control management to handle updates without risking compliance. 𝗜𝗺𝗽𝗮𝗰𝘁: Consistent, compliant production processes and fewer disruptions during inspections. 3️⃣ 𝗠𝗮𝗿𝗸𝗲𝘁𝗶𝗻𝗴 & 𝗦𝗮𝗹𝗲𝘀 𝗪𝗵𝗮𝘁 𝘁𝗵𝗲𝘆 𝗰𝗮𝗻 𝗹𝗲𝗮𝗿𝗻:   - What constitutes a compliant claim (e.g., what you can say about “performance” or “safety”).   - The approval process for promotional materials.   - Country-specific advertising regulations. 𝗜𝗺𝗽𝗮𝗰𝘁: Clear, compliant messaging that builds trust and avoids regulatory scrutiny. 4️⃣ 𝗦𝘂𝗽𝗽𝗹𝘆 𝗖𝗵𝗮𝗶𝗻 & 𝗣𝗿𝗼𝗰𝘂𝗿𝗲𝗺𝗲𝗻𝘁 𝗪𝗵𝗮𝘁 𝘁𝗵𝗲𝘆 𝗰𝗮𝗻 𝗹𝗲𝗮𝗿𝗻:   - Import/export regulations, including customs requirements for medical devices or pharma products.   - Supplier qualification and the need for compliance audits.   - Traceability requirements for raw materials and components. 𝗜𝗺𝗽𝗮𝗰𝘁: Fewer supply chain disruptions, compliance with traceability standards, and better supplier relationships. 5️⃣ 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗪𝗵𝗮𝘁 𝘁𝗵𝗲𝘆 𝗰𝗮𝗻 𝗹𝗲𝗮𝗿𝗻:   - Regulatory timelines and costs for market entry.   - Key differences between regional regulations (e.g., EU MDR vs. FDA). 𝗜𝗺𝗽𝗮𝗰𝘁: Smarter investments and more realistic go-to-market strategies. 6️⃣ 𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗪𝗵𝗮𝘁 𝘁𝗵𝗲𝘆 𝗰𝗮𝗻 𝗹𝗲𝗮𝗿𝗻:   - Regulatory milestones to integrate into project timelines (e.g., clinical trial approvals, submission timelines).   - Risk management principles related to regulatory delays. 𝗜𝗺𝗽𝗮𝗰𝘁: Streamlined project execution with fewer compliance-related roadblocks. When departments understand the basics of RA, they can proactively integrate compliance into their processes, reducing delays, risks, and inefficiencies. Have you seen the value of RA knowledge spreading across teams in your company?

Develop And Write A Great Policy And Then Assume No One Will Read It Standards and controls, including policies, are an important part of an effective ethics and compliance program. While I have many other #SundayMorningComplianceTip posts that address policy development and writing, there is one important assumption I think policy owners should make when it comes to policies: assume no one will read your policy. Hopefully the relevant employees will read the policy, but the point is to recognize that your busy employees are probably subject to scores of policies and have equally little amounts of time and interest in reading new policies. If we assume that employees are not going to read a new policy, we force ourselves to think a bit more about how to bring the policy to your employees and help them understand the requirements. Here are some examples of how to apply this assumption in practice: 1. Engage Leaders, Managers & Supervisors: You can do this through Compliance Manager Toolkits (a one page summary that helps managers understand their role with respect to the policy and how they can support employees with the new policy) and providing them short Compliance Tips of the Month so they can talk with their teams about some key points about the policy that are relevant to their team and will resonate with them. 2. Marketing Campaign: Embrace the marketing principle of the “Rule of 7” - you need to have multiple messages and communications for the relevant employees to help ensure that they are aware of the policy and the key policy requirements. 3. Help People Learn: This can include training (online or live), engaging them during the policy development stage, providing real life (or at least realistic) FAQs that provide realistic scenarios that relate to the policy, and advising employees on how to deal with any challenges or awkward situations that the new policy might create for them (e.g., how do you decline a gift that violates your new gifts and entertainment policy without burning important business relationships). Even if your employees are going to read all your policies, applying this assumption will only help support both your employees and your ethics and compliance program. Policy documents are just the written version of the policy - there are many other ways that we can communicate a policy to employees and help ensure the words on the page are reflective of the policy in practice. My #SundayMorningComplianceTip series is taking a break for the next few weeks and will return in January. _____ #SundayMorningComplianceTip #EthicsAndComplianceForHumans 📚 Want to get more compliance ideas and suggestions like this? Connect with me here on LinkedIn or get your copy of my book called Ethics & Compliance For Humans (published by CCI Press and available in print and kindle format on Amazon and various other online book stores)

⚡I am just going to say it: more often than not, organizations in the biotech industry allow training to take a back seat to immediate production demands. But here's the reality... neglecting training and education today leads to costly errors tomorrow. 🌟 Lessons from High-Reliability Industries: Industries like aviation, nuclear power, and healthcare have learned this the hard way. By investing heavily in training and human performance, they've not only reduced errors but also enhanced operational efficiency and safety. *Aviation introduced Crew Resource Management (CRM) training, drastically reducing communication-related errors and fostering a culture of teamwork and safety. *Nuclear Power implemented rigorous operator training and error prevention tools, leading to a significant reduction in incidents and unplanned shutdowns. *Healthcare adopted simulation-based training for surgical teams, resulting in fewer errors and improved patient outcomes. 🚧 Why is there resistance? Despite these clear benefits, here's what I have come to find: *Operational Pressure: Immediate production demands overshadow long-term training needs. *Perceived High Costs: Training is seen as expensive, with upfront costs and downtime being deterrents. *Short-Term Focus: Emphasis on immediate gains and quarterly targets leads to deprioritization of continuous education. *Cultural Resistance: Established routines and a one-time training mindset create resistance to ongoing learning. *Regulatory Compliance Mindset: Companies often prioritize meeting regulatory training requirements over broader employee development. *Lack of Visible Outcomes: The long-term benefits of training are not immediately quantifiable, leading to skepticism. *Leadership Gaps: Insufficient leadership advocacy for training signals that it is not a priority. 💡 So what do we need to do? *Align Training with Strategic Goals: View training as an essential part of achieving operational excellence, not just a compliance requirement. *Embed Training into Daily Operations: Make training a regular, integral part of the workday. Short, focused sessions can be just as impactful as longer courses. *Lead by Example: Senior leaders must visibly prioritize and participate in training initiatives, sending a clear message that continuous learning is non-negotiable. *Invest in Sustainable Training Infrastructure: Modernize your training methods—think e-learning platforms, VR simulations, and dedicated training time. *Create a Culture of Continuous Improvement: Foster an environment where learning is ongoing, and where mistakes are seen as opportunities for growth, not just failures. 🚀 Incorporating regular training into the workday = building a resilient, high-performing workforce capable of dealing with the complexities of biotech manufacturing. The investments we make in our people today will drive our success tomorrow and it's time we make training a top priority in our industry. #manufacturing #training

The last claim your company faced probably came from someone who "completed" their compliance training. Compliance programs built solely around communicating company policies fail to reduce real-world risk. Checking boxes doesn't change behaviors, and it doesn't protect companies from claims. Effective compliance training goes beyond information sharing. It develops essential workplace skills, reinforces measurable behaviors, and links directly to outcomes that executives care about. Clients partner with us to build respectful workplaces because strong behavioral norms directly translates into measurable business results: • Teams that demonstrate respectful behaviors outperform others by 10–15%. • Organizations with healthy cultures have fewer employee-relations claims. • Effective training reduces investigation expenses and compliance risks. Executives expect clear proof that training programs impact critical business metrics: Instead of reporting, "95% completed harassment training," Report, "Harassment-related claims dropped 20%, reducing investigation costs." Instead of highlighting, "High ratings for DEI training," Highlight, "Teams completing our inclusion training saw 18% lower turnover." Compliance should always be the natural outcome of skill-building and behavior change—never the main goal of your training programs. Completion rates alone don't protect your company. Behavior change does.

Compliance isn’t about checking boxes. It’s about changing behaviors. The hard truth: signed documents won't protect your organization when it matters most. After spending the last 12 years building learning solutions, seeing firsthand what works and what fails. I've realized that most organizations fundamentally misunderstand compliance. They focus on documentation when they should be focused on behavior change. A signature doesn't protect your organization. A workforce making consistent, compliant decisions does. This shift in perspective changes everything. At Continu, we've reimagined compliance training from burden to strategic advantage. Effective programs engage employees in ways that drive lasting behavior change. They integrate seamlessly into workflows rather than disrupting them. They're championed by leaders who visibly demonstrate their commitment. The future is already here: - Predictive analytics identifying risks before violations occur. - Automated updates keeping pace with evolving regulations. - Microlearning that builds knowledge incrementally, not annually. Organizations that thrive embed compliance into their operational DNA. This isn't just about protection. It's about creating cultures of integrity. Are you still checking boxes? Or are you changing behaviors? #behavioralchange #ComplianceTraining #CorporateCulture #compliance #risk #AlwaysLearning #Continu #LMS #thoughtleadership

#ThrivingAtHealthcare (3of9): Navigating Regulatory Compliance Keeping up with changing healthcare regulations can be challenging. As hospital administrators, our focus should be on building a strong culture of compliance through people, culture, and foundational practices. #WhyItMatters: Regulatory compliance ensures patient safety, improves care quality, and protects the hospital from legal and financial penalties. A culture of compliance builds trust and credibility. How to Navigate Regulatory Compliance: 📚 Educate and Train Staff: Provide continuous education and training on current regulations and standards. Ensure all staff members understand their roles in maintaining compliance. 👥 Foster a Compliance-First Culture: Create an environment where compliance is a shared responsibility. Encourage staff to stay informed and adhere to regulations in their daily activities. 🔄 Implement Clear Protocols: Develop and enforce clear, comprehensive protocols for compliance-related tasks. Regularly review and update these protocols to reflect changes in regulations. 📝 Encourage Open Communication: Establish open lines of communication for staff to report compliance concerns or seek guidance. Regular meetings and anonymous reporting systems can be effective. 🤝 Lead with Integrity: Demonstrate your commitment to compliance by adhering to the highest ethical standards. Set a positive example for your team by prioritizing compliance in all decisions. By embedding compliance into our culture and practices, we can ensure our hospitals operate ethically and effectively. Let’s work together to maintain the highest standards of regulatory compliance. #Healthcare #HospitalAdministration #RegulatoryCompliance #PeopleFirst #CultureOfIntegrity #ContinuousImprovement

The topic of compliance training often elicits a response of gritted teeth and rolling eyeballs. My Learning Uncut Elevate guest Michelle Parry-Slater argues that despite its reputation, compliance learning is crucial and can (and should be) a valuable learning experience. Michelle passionately argues that compliance training is not just a box-ticking exercise but a critical component of organisational learning that ensures safety, legality, and overall well-being. She emphasises the importance of making compliance learning engaging and relevant, comparing it to a shop window where the best wares should be displayed to attract and educate effectively. We explore various strategies to enhance compliance learning: ·      Personalisation and Relevance: Tailoring training to specific roles and scenarios within the organisation to ensure relevance and reduce wasted time. ·      Engagement through Real Stories: Using real-life scenarios and case studies, or encouraging participants to share real stories, to make the training relatable and memorable. ·      Technology and Microlearning: Leveraging technology to deliver training in digestible, engaging formats and/or connect people to learn together - especially in environments where learners are dispersed or have limited time. ·      Stakeholder Engagement: Collaborating closely with stakeholders to align on the purpose and execution of compliance training, ensuring it meets both legal standards and learning objectives. This episode is a call to action for all learning professionals to reevaluate and elevate their approach to compliance learning, transforming it from a mundane task to a cornerstone of organisational learning culture. Listen on your favourite podcast app or use this link to the landing page to access additional resources including past Learning Uncut episodes that showcase outstanding compliance learning initiatives. https://lnkd.in/eVm97EVW #LearningUncut #ComplianceTraining #WorkplaceLearning #LearningExperienceDesign #LearningCampaign