Assure compliance with CDISC requirements?
Today, staff in medical offices have access to a number of systems that may be used for the access and management of Protected Health Information.
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process
FDA guidance documents on Pharmaceutical cGMPs
Meets the legal requirements of Federal statutes
EHR system in a submission to FDA
FDA and U.S. Customs and Border Protection
Services to international borders
New product-marketing approvals
Criminals are coming up with new high-tech ways of hijacking
Preventing fraud should be a standard part of any compliance plan
Provides a higher level of quality
How to handle tricky termination decisions
Implementing a mentorship program
What works in one state will not work in another
FDA’s requirements without creating undue burdens for the organization
Medical devices subject to FDA regulation
Learn how to take "reasonable care"
How to write, organize, and maintain SOPs and train personnel
What to expect in 2019
Without falling afoul of the law
FDA focusing on Digital Health?
Electronic Records & Electronic Signatures
Try their hand at solving the issue, while balancing compliance
European Data Protection Regulation
Compliance within the US, "gray areas"
Find patterns, red flags and stop scams
By FDA Expert 30+ years exp.
Employees without fear of retribution from the regulatory agencies
The most interesting court decisions in 2018
Must learn how to navigate the social media environment