Webinar on How to Implement HIPAA Requirements in GxP Regulated Establishments

MessageThis Webinar is over
Date Sep 17, 2014
Time 1 PM
Cost $189.00
HIPAA, which stands for Health Insurance Portability & Accountability Act, does not just apply to health insurance. The rules apply to all companies with Personal Health Information (PHI) in electronic formats – doctors, health plans, pharma organizations, government programs, research organizations, testing organizations, pharmacies, clinics, IT services for regulated organizations, and more. In March of 2013, the HIPAA Omnibus Final Rule took effect, with major changes around Business Associate definitions, requirements for security breaches, and increased focus on privacy and greater fines for non-compliance.
Anyone dealing with Patient Health Information (PHI) in the Pharma / Biotech / Medical Device and other Life-sciences companies, is subject to the HIPAA regulations as well as GxP Regulations. Sometimes the two regulations overlap, while other times something that would pass inspection by the FDA might not pass a HIPAA inspection and vice versa. Consequently, it is important to implement both sets of regulations.
This webinar will explain HIPAA and the impact of HIPAA to the Life-sciences Industry, followed by explaining how to leverage the GxP work that a company already has, to create a cost effective approach to complying with both GxP and HIPAA requirements.
Areas Covered in the Session :
Overview of HIPAA and the 2013 Rule
Recent Changes to HIPAA
Penalties for Non-Compliance
The culpability of Business Associates for Non-Compliance
Enforcement History
Title II – Administrative Simplification
HIPAA Privacy
HIPAA Security
HIPAA Identifiers
HIPAA at GxP Facilties
Areas of Overlap
Areas of Disparity
Leveraging GxP Controls for HIPAA Compliance
Who Will Benefit:
Clinical Research Associates
Clinical Auditors
Clinical Operations managers
VP of IT
IT Managers
IT Personnel
Quality Control
Quality Assurance
Regulatory Affairs
Document control managers
Price Tags:
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Complaince Trainings
5939 Candlebrook Ct, 
Mississauga, ON L5V 2V5, 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com


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