Articles
CLINICAL
COMPLIANCE
MANUFACTURING
COMPLIANCE
COMMERCIAL
COMPLIANCE
GOVERNMENT
PROGRAMS COMPLIANCE
HEALTHCARE
REFORM-RELATED
AUDITING
ARTICLES
CLINICAL
COMPLIANCE ARTICLES
Expanding GCP Quality Systems for Inspection Readiness
By: Beth Kline
Ensuring Quality Throughout the Clinical
Process - Published in Life Science Leader
By: Annette Horner and Beth
Kline
Proposed Rule for Post-Marketing
Safety Reporting of Combination Products
By: Annette Horner
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MANUFACTURING
COMPLIANCE ARTICLES
GMP Vendor Oversight - Compliance Strategies
By: David Greeley
Failing to Establish and Maintain CAPA
Systems? Your Company Could Be At Risk
By: Venessa Piper-Givler, Erica Brooks, and Yasmeen Muhammad
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COMMERCIAL
COMPLIANCE ARTICLES
CIAs: A look back to the future at OIG investigations
By: Jamie L. Kendall, Esq.
Data forensics: effectively responding to non-compliance allegations
By: Clarissa Crain and Chrissy Spicer
This article originally appeared in the June issue of Regulatory Affairs Pharma.
The "Mega Fine" Goes Giga: The Significance
of Proactive Compliance Measures in the Age of Billion Dollar Penalties
By: Jamie L. Kendall, Esq.
2010 Proposed Amendments to the Federal
Sentencing Guidelines Help Companies Withstand Judicial Scrutiny
Through Proactive Approaches to Corporate Compliance Programs
By: Jamie L. Kendall, Esq.
Building
a Compliance Program
By: Chris
Cobourn and Clarissa Crain
Texas Medicaid Reporting
Requirements
By: Jessica Ebert
Is Vermont Trying to Get
Manufacturers to Just Stop Detailing and Sampling Altogether?
By: Judy Fox
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GOVERNMENT
PROGRAMS COMPLIANCE ARTICLES
A Candid Interview with the Retiring Director
of Pharmacy Affairs for the Public Health Service
By: Bill
Baxter
Authorized Generics and TRICARE
By: Lisa
McNair
Who Ya Gonna Call (Not Ghost
Busters...)
By: Bill
Baxter
Surprise Tricare Ruling Handed
Down
By: Dave
Rice
Department of Veterans Affairs, Dear
Manufacturer Letter - October 16, 2009
By: Dave Rice and John Avicolli
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HEALTHCARE
REFORM-RELATED ARTICLES
Healthcare Reform Part I -- The Principles of
a Risk-Based Compliance Program
By: Clarissa Crain and Chrissy Spicer
Summary on Recent Healthcare Reform
Legislation
By: Jordan
Mummau
Healthcare Legislation and the
Senator Brown Effect - What Should GP Professionals Be Thinking Now?
By: Chris Cobourn
Most Important Vote on Healthcare
Reform
By: Jess Ebert
Reform In Rare Form
By: Sabrina Skari
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AUDIT ARTICLES
Don't Get Burned
By: Tim Krzeminski
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