Regulatory Compliance (in Healthcare)
In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls, to ensure that all necessary governance requirements are met.
In a highly regulated, high-risk industry like healthcare, compliance is especially important. Compliance in healthcare can cover a wide variety of practices and observe internal and external rules. But most healthcare compliance issues relate to patient safety, the privacy of patient information, and billing practices.
We organized this session, to give you a bit of an overview from a QA point of view.
Who should join this session ?
People with experience in IT and SLDC, but no particular experience with Regulation or Compliance.
During this session you will learn about
- What is regulation (examples, domains, definitions)
- Why is regulation necessary in healthcare
- Quality Management in healthcare
- GxP Compliance
- Computer Systems Validation (CSV)
- Change Control
- Audits and inspections
- Practical tips for QA