The OrthoWorx Center for Excellence in Orthopaedics at Grace College proudly offers the nation’s only graduate program designed specifically by and for orthopaedic regulatory and clinical affairs professionals. Students can earn either a graduate certificate or a M.S. in Regulatory and Clinical Affairs in this accelerated, one-year program.
As the “Orthopaedic Capital of the World,” Warsaw, Indiana contains one of the most concentrated clusters of economic activity anywhere in the United States. Today, the Warsaw region is headquarters to nearly one-third of the $38 billion global orthopaedic industry, which represents one of the most significant components of Indiana’s economy.
Grace College and OrthoWorx, with support from the Lilly Endowment, have partnered to provide this graduate program targeted to professionals who desire a thorough knowledge of the laws and regulations mandated by the federal government, especially the Food and Drug Administration (FDA), as they apply to the development, testing, approval, manufacturing, and commercialization of orthopaedic products. Prospective students could include:
Candidates must have completed a bachelor’s degree from an accredited institution. In some cases, candidates who can successfully complete a bachelor’s degree while enrolled in the ORCA program may also be considered.
Examples of courses in this major:
The student will be introduced to the Orthopaedic Regulatory and Clinical Affairs (ORCA) program and staff, as well as the larger campus community and the resources available to them. Additionally, the history of orthopaedic medical device manufacturing will be discussed, as well as current industry issues and the economic implications of being located in the "Orthopaedic Capital of the World". Students will follow the life of an orthopaedic product from concept to obsolescence. Along the way, the role of the FDA and regulatory and clinical affairs will be showcased and career options will be explored in depth.
This course is an introduction to the general anatomy and physiology of the musculoskeletal system and related structures. This course includes structural make-up, group composition, relationships, and location of each bone. Common types of fractures and treatments will be discussed. Also covered will be common pathologies and treatment options relevant to the orthopaedic industry in general.
This course will examine the role of the law in the orthopaedic industry and in the American health care system. The course will provide an understanding of the laws, statutes and regulations affecting the orthopaedic and medical device industry. The course will include discussion of the interplay between ethics and law. The role of government in the regulation of the medical device industry will be examined.
This course will review the elements of effective technical writing. The course will identify the types and nature of documents created by professionals in clinical and regulatory affairs and will provide the student with the opportunities to develop skills needed to successfully author and edit such documents.
This course focuses on the fundamentals of clinical trials with emphasis on study design, scientific methodology, data acquisition and management and statistical analyses. Common types of study designs will be compared and contrasted and processes to maximize data integrity will be discussed.
This course covers the regulation of medical devices by government and the requirements to demonstrate safety and efficacy to the government prior to the device being allowed by them on the market. This demonstration is called a "submission". This course focuses strictly on medical devices, with an emphasis on the orthopaedic industry.
This course is an overview of Good Clinical Processes (GCP) involved in the device approval process, the regulations that govern IDE studies, the roles of the Sponsor, the Investigator, the CRO, and/or subjects in meeting standards of GCP in conducting and participating in FDA mandated trials within the USA. Included will be Informed Consent and Adverse Event exercises as well as Essential Document development and review.
RCA 570 prepares the student to understand the history and scope of the FDA's oversight of the medical device industry. Students will also learn best practices for building internal compliance systems and working with the FDA through the entire examination process.
This course focuses on the fundamentals of medical device clinical trials with emphasis on the development, execution and management of a multi-center clinical study.
The course is designed to provide an introduction to international regulatory affairs, including information on the skill set required, global business culture and the status of global harmonization of regulations. The course will cover specifics of medical device registration in various markets, including the European Union, Canada, Australia, Japan, South Korea, China, and selected countries that are currently developing a medical device regulatory system. The emphasis will be on premarket requirements for general medical devices.
This learning session is an overview of clinical monitoring and auditing skills required in an IDE device clinical trial. The roles of the Sponsor, the Investigator, the IRB/IEC, the CRO, and/or subjects in meeting standards of GCP (FDA or ICH) in conducting and participating in FDA mandated trials within the USA will be developed with the students. This learning opportunity consists of a comprehensive review of clinical monitoring covering the accepted and mandated monitoring types; the essential document review; the test article accountability review, reporting, rules and regulations; the compliance requirements and corrective action plans; and follow up to the corrective action plans. This course will cover the similarities and differences between the FDA regulations and the ICH GCP (E6) guideline. This course reviews key documents and elements of the clinical investigation including source and data in relation to the study file and accepted practice. This course will develop the audit skill and responsibilities required of the Sponsor, Investigator and IRB/IEC. In addition, this course will develop the plan and education required to prepare the student to understand and be able to undertake an Investigative site or sponsor site for a regulatory body inspection. Included in this review will be monitor plan development and implementation, formal monitor report development, informed consent development review and finalization, site development of file systems and reporting procedures for specific and mandated elements of an IDE clinical trial.
This Capstone experience covers all the elements of prior learning resulting in a cumulative body of work. The course emphasizes orthopaedic medical device project management from a combined clinical and regulatory perspective and will provide the tools necessary for project planning in a challenging global marketplace.
The individuals who will challenge you to learn:
Clinical Affairs Manager, GE Healthcare
M.D., State Medical University "N. Testemitanu", Chisinau, Moldova; B.S. Biology, McGill University, Montreal, Canada.
Medical Director/Safety Officer, DePuy Orthopaedics
Medical Doctor, Universidad de la Sabana, School of Medicine, Bogoťa, Colombia; University of Miami, School of Medicine, Jackson Memorial Hospital, Miami, Florida.
President and CEO, Mesa Medical Device Consulting, (Regulatory-Clinical Technical Writing).
Ph.D. Physiology, Indiana University, Bloomington, Indiana; B.A. Biology, Villa Madonna College, Covington, Kentucky.
Principal, Mark T. Piazza, LLC; Retired Assistant General Counsel/Corporate Counsel/Vice President, Law and Secretary, DePuy Orthopaedics
Juris Doctor, with distinction, John Marshall Law School, Chicago, Illinois; Masters of Science-Library Science, University of Illinois; Bachelor of Arts, Philosophy, St. Mary's Seminary College.
Retired Vice President, Regulatory and Quality Systems, Zimmer
RPh. Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania. Author of 145 Publications and Book Chapters.
President and CEO, Clinical and Regulatory Affairs Director; J. Tyson & Associates, Inc., (Clinical Research Organization)
Master of Science Health Care Services, Cardinal Stritch College; Bachelor of Arts in Biology and BSN from Alvemo College.
Director, WW Biostatistics & Data Management, DePuy Orthopaedics
M.B.A. State University of New York at Albany; M.S. Biostatistics, Western Michigan University; B.A. Mathematics, Hope College.
Consultant in Regulatory Affairs, Compliance and Quality Assurance (retired from Zimmer); V.P. Regulatory Affairs and Compliance for Zimmer
Ph.D. and M.S. in Microbiology, Colorado State University, Colorado; B.S. Bacteriology, Colorado State University, Colorado.