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Webinar on How to Implement HIPAA Requirements in GxP Regulated Establishments

Event Details

Webinar on How to Implement HIPAA Requirements in GxP Regulated Establishments

Time: September 17, 2014 from 1pm to 2:30pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga, ON
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: compliancetrainings
Latest Activity: Aug 27, 2014

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Event Description

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

Structure

History

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 EDI

HIPAA Identifiers

HIPAA at GxP Facilties

Areas of Overlap

Areas of Disparity

Leveraging GxP Controls for HIPAA Compliance

Who Will Benefit:

Doctors

Nurses

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:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

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, 
Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

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