The Sunshine Act: Reporting for Clinical Trials

Joy L. McElroy

Starting at

$349


Buy Now

The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act.

Course Objective

Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Participants will able to understand who is required to report under the sunshine act and what is reported under the sunshine act and the exclusions under the sunshine act.

 

Course Outline

  • Purpose of the Sunshine Act.
  • Who is required to report under the Sunshine Act?
  • What is reported?
  • Exclusions.
  • Tracking.
  • Penalties.
  • Useful links.

 

Target Audience

  • Human Subjects Research Professionals.
  • Healthcare Personnel interested in exploring the field of Clinical Research.
  • Clinical Research Coordinators.
  • Principal Investigators/Physicians.
  • Administration in charge of Clinical Research.
  • Regulatory Compliance.
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Joy L. McElroy,

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.


Follow us

Toll Free

1-866-978-0800

Fax

1-888-883-7697