Strategies for streamlining the registration application process for faster approval.
The materials will discuss IT security in the context of an overall organization security program including the value and approach of an IT security vulnerability test.
Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.
It will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.
Non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety.
The entire HIPAA Security Rule and uncover simple methods to comply and create policy.
The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.
It will help to comply with regulatory requirements with minimized overhead and resource burden.
You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices.
How do you know if you are pressing the right key, let alone performing the best test?