Designed for non-lawyers, Maine Law’s Compliance Certificate Program, stresses skill building for compliance professionals.
The individual courses in the program provide “envelopes” for delivering the skill building and development components and are designed to give participants hands-on experience in the various tasks expected of compliance professionals. In addition to the introductory course and a course addressing Enterprise Risk Management, other courses will address a variety of topics relevant to important sectors of Maine’s business, not-for-profit, and government communities.
Dates for upcoming courses in the Certificate in Compliance Program will be announced soon.
Sample Course Offerings
This course explores the foundational principles of compliance: what are the sources of compliance requirements; where are the requirements found; what behavior satisfies “compliance;” and how do compliance personnel motivate compliant behavior throughout their organization. Participants will examine the language of compliance, how to anticipate and address various compliance issues, the motivations and agendas of the various actors and actresses on the compliance stage, and the structure and elements of a successful compliance program. In addition, this course addresses the broader scope of enterprise risk management (ERM), with specific attention to the vocabulary, concepts and methodology underlying ERM, various approaches to risk identification, measurement and mitigation, and the distinct roles that insurance and compliance have in ERM.
The myriad state, federal, and foreign regimes governing information privacy, cyber security, and data breach notification raise serious compliance challenges for virtually all organizations today. This course examines the principal regulatory, litigation, innovation, competitor, reputational, and other risks within these realms and offers practical skills and guidance for mitigating these risks and navigating complex related compliance and ethical issues. Participants will gain understanding and knowledge about how to build and implement a compliance program (including defining roles and responsibilities and drafting documentation), the compliance challenges in this area, and the major tools and methodologies used to operationalize the compliance program, including privacy impact assessments, security incident risk assessments, privacy by design, and privacy by default.
If organizations connected to the life sciences disregard relevant regulations and other compliance requirements in health care and research, they risk fines, civil litigation, and even criminal charges. Focusing primarily on the compliance challenges posed by human and animal subject research and clinical trials, time permitting we will also explore compliance considerations relevant to health care more broadly, including HIPAA and other patient privacy rights, and public health considerations including quarantines and vaccinations.
This course explores compliance methodologies in the context of food safety, both for humans and pets, and analogous principles for the emerging cannabis markets. Ms. Pfannensteil discusses the elements of leadership in the compliance arena, quality system implementation, effective decision-making, and the design and implementation of effective processes and procedures. In addition, she presents guidance on developing appropriate specifications, standard operating procedures, and other conditions for creating safe products, hazard analysis and control, verification, validation and recordkeeping, and strategies for correcting things that are going wrong.
Introduction to Compliance and Enterprise Risk Management: Foundational Principles (Winter Presentation)
This course will reprise the material presented in the initial course. Because this course is required for the Compliance Certificate, it is being presented a second time to accommodate cohort participants who are unable to take the course during its first presentation.
This course covers employment statutes and regulations relevant not only to HR and compliance professionals, but to any employer or employee seeking a basic understanding of the increasingly complex legal framework governing the workplace. Topics include the formation and termination of the employment relationship, discrimination in the workplace, the ADA and its accommodation requirements, sexual harassment, FMLA, FLSA, and other key regulations, as well as important judicial decisions that interpret them. We will focus in particular on structuring appropriate compliance strategies and initiatives for addressing the nuances and often competing interests presented by these topics.
Pharmaceuticals and cosmetics are among our most highly regulated industries and present many challenges for compliance professionals. This course will examine the principal structures and regulations applicable to these industries. Concepts to be discussed include prohibited acts (such as adulteration and misbranding), pre-market approval of new drugs, off-label uses, and enforcement of the principal governing laws and regulations. This course will build upon the foundational principles explored in our previous courses and will further develop for compliance professionals an effective methodology for navigating within complex industries.
Creating Value While Navigating Compliance Traps and Challenges in Contract Procurement and Management
Contracting can create value and opportunities for all parties to a contract, but contract procurement, formation, management and administration present countless challenges for compliance personnel in both the public and private sectors. This course will explore the fundamentals of contract formation, management, and administration from a compliance perspective. In addition, it will consider pre-solicitation requirements, the role of various stakeholders, due diligence, contract award, collateral policies and procedures, as well as the role of technology in contracting and contract management. At each stage of the process the course will highlight compliance and ethical considerations and offer practical strategies for navigating this complex area using case studies and hands on exercises
Attendees may register for any number of courses, which cost $1,000 each. Completion of at least five courses (including the introductory course) is required for the certificate. Each course will be presented live.
For additional information, please contact email@example.com or 207.780.4368.
Classes will be held in Payson Smith Hall (Room 41), University of Southern Maine, 96 Falmouth Street, Portland.