Overview This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. Why should you Attend FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management. FMEA has been used as part of…

OVERVIEW Webinar presents method used to baseline organization’s effectiveness, efficiency, and reliability of transactional, design, or manufacturing processes. Baseline is important to determine if change is significant improvement. Once process issues are known, fishbone diagram problem solving and other methods to correct ineffective processes are presented. WHY SHOULD YOU ATTEND Traditional methods of Process Improvement demonstrate high failure rates: Business Process Reengineering (BPR) 50% to 85%, Total Quality Management (TQM) 75%, Six Sigma 50% to 90%, and Lean Six Sigma 50% to 95%. You can increase your odds…

OVERVIEW HR metrics should not be developed in a silo or owned exclusively by human resources. To be of value, HR metrics should measure the business factors that are important to the organization not just HR and should be co-owned by HR and the C-suite, other departments, and line managers. The right or best metrics are HR metrics that incorporate the input of stakeholders and contribute to informed decision-making. From this perspective, HR metrics should be predictive and action oriented.…

OVERVIEW Cybercriminals are always looking for inattentive compliance departments and will take advantage of vulnerabilities in your processes. Our upcoming webinar discusses transaction laundering, alternative payment methods used to launder money and how to prevent it. The webinar covers the following key areas: Who is the “payments hustler”? AML rules and regulations and how regulators/legislators have gotten involved Transaction laundering and what can you do about it? LEARNING OBJECTIVES Learn about how fraudsters use alternative payment methods to launder money.…

SCCE Regional Conferences provide a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational opportunities for compliance professionals to strengthen the industry. Main Topics Covered: • Why People Do Unethical Things • Compliance Risk Assessments • Privacy: Around the World in 60 Minutes • Emerging Technology and Privacy Incident Management • Compliance Program Effectiveness • Ethics and HR Partnerships

Overview This webinar will cover all aspects of testing to ensure that a computer system regulated by FDA "does what it purports to do," as per the guidance on computer system validation (CSV) from FDA, first issued in 1983. It will also touch on elements of testing necessary to ensure compliance with 21 CFR Part 11, FDA's guidance on electronic records and electronic signatures (ER/ES) published in 1997. We will cover all of the required policies and standard operating procedures…

Overview Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management. We'll cover the steps of Installation Qualification (IQ),Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. Why should you Attend Failure to validate…

Tracking all the various components of a compliance programme from onboarding partners to training to managing conflicts of interest and gifts, travel and expense (GTE) expenses can be challenging for many organisations. Organisations can sometimes lack the right tools to tackle data collection and reviews across complex lines of business. With limited resources, it can be a struggle to meet monitoring demands. This can increase the chance for delayed analysis, exposing the organisation to compliance and integrity risks. To prevent…

OVERVIEW Ms. Nash-Hoff’s presentation will cover how supply chain management is affecting the decision of where to source manufacturing. She will discuss such factors as hidden direct and indirect costs. Transportation costs, threat of Intellectual Property theft, quality problems, and the new tariffs on steel and aluminum are changing the status quo. She will present a true understanding of the “Total Cost of Ownership” (TCO) concept and share why more and more companies are either choosing to reshore their manufacturing or nearsource…