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How to Implement HIPAA Requirements in GxP Regulated Establishments

Wednesday, September 17, 2014 | 10:00 AM PDT | 01:00 PM EDT | Duration : 90 Minutes | Register Now
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 or Biotech or Medical Device and other Life-sciences
companies, is subject to the HIPAA regulations as well as GxP
Instructor:
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Angela Bazigos
Dr.Angela Bazigos, is the CEO of
Touchstone Technologies Silicon Valley,
Inc. "Knowledge is Power". She has 35
years of experience in the Lifesciences
industry spanning GLP, GCP, GMP,
Medical Devices & 21 CFR 11 and has a
patent aimed at
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
speeding up Software Compliance.
Ms. Bazigos is a Past President of
PECSQA, a member of the SQA, ASQ,
DIA and RAPS and consults to
LifeScience Investment Groups as well
as to Pharma or Biotech or Medical
Device companies on compliance
matters, including strategy,
submissions, quality
assurance and remediations following
action by the FDA. More recently, Ms.
Bazigos co-authored Computerized
Systems in Clinical Research or Current
Data Quality and Data Integrity
Concepts with FDA, DIA and Academia.
Upcoming Webinars:
Medical Device Changes and the
510(k)
How to Implement HIPAA
Requirements in GxP Regulated
Establishments
FDA Adverse Event Reporting for
Drugs and Medical Devices
Available Recorded Webinars:
Design Inputs - Design Outputs
Traceability Matrix - Principles of Lean
Documents and Lean Configuration

Navigating your w ay through ISO
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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

Acceptance Activities in FDA QSR
About Compliance Trainings:

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13485
Assessing FDAs Proposed Changes to
the 510(k) Process
How to Manage a Product Medical
Device Recall Efficiently and Effectively
21 CFR Part 820 - Quality System
Regulation - Applying Principles of
Lean Documents and Lean
Configuration
Good Practices for FDA 510(k):
Content and Format
Design Inputs - Design Outputs
Traceability Matrix - Principles of Lean
Documents and Lean Configuration
HIPAA Privacy and Security 2014
Update, Including the Latest Trends
in Omnibus Breach
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