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Pharma Quality Assurance: FDA Compliance Solutions for Pharma Quality Managers

FALLS CHURCH, Va., April 25, 2013 PRNewswire-iReach/ -- FDA News Launches Pharma Quality Advisor:
The First Compliance and Management Website for Pharma Quality Managers


Pharma Quality Advisor is the first and only site that provides Pharma Quality Managers with the practical help they need to keep their facilities operating in compliance with GMP regulations. 

In addition to practical job function and management help, Pharma Quality Advisor provides updates and analysis of critical regulatory developments affecting GMPs, along with practical guidance to prepare for and survive FDA and other regulatory inspections.

"We believe Pharma Quality Advisor provides one-stop help that every Pharma Quality Manager can use to do their job more efficiently and effectively … and avoid costly GMP regulatory and compliance pitfalls", says Dan Landrigan .

To that end,Pharma Quality Advisor is uniquely organized around the core job functions and responsibilities of the Pharma Quality Manager:

  • Managing quality systems
  • Implementing an effective risk management plan that meets regulatory requirements
  • Implementing and managing effective Corrective and Preventive Actions (CAPA)
  • Preparing for and surviving inspections by the FDA and other regulators
  • Managing and monitoring outsourced suppliers and contractors
  • Analyzing FDA enforcement trends

First, the Pharma Quality Manager lives in constant fear of quality system failures that can result in regulatory enforcement actions, recalls, lost revenue, and ultimately patient harm.    

Second, Pharma Quality Managers also understand that the quality systems they manage are a key driver in delivering successful and timely product launches, optimizing revenue streams, enhancing the company's reputation, and maximizing shareholder value.

Quality managers spend their day monitoring … assessing … investigating … integrating and reporting.  In addition, the Pharma Quality Manager must interface with a host of internal systems, such as SOPs …  process maps … CAPA systems, and much more."

It's a complex job and it's getting more complex.  That's why we developed Pharma Quality Advisor.  It provides the complete, one-stop, guidance that Pharma Quality Managers need to perform all of their job functions more effectively … integrate more efficiently with the complex systems and procedures around them … and keep their operations in strict compliance with the law.    

Published by FDAnews, Pharma Quality Advisor provides content that has been shaped by the insider knowledge of a strong advisory board, including:

  • William Reiss , Senior Manager Supplier Quality Agreements & Global Sample Retention, Celgene
  • Patrick D. Stone , President/Lead Consultant, TradeStone QA, LLC
  • David Charapp , Partner, Duane Morris LLP
  • Philip Crooker , Director, Global Regulatory Strategy – CMC (US), Shire Pharmaceuticals
  • Nikki Willett , Life Sciences Global Team Lead Quality & Compliance Practice, Accenture;
    Founder/Owner, Quality & Regulatory Network
  • Steven Sharf , Founder/President, GMP Concepts
  • Alan Minsk, partner and practice leader of the Food and Drug Practice, Arnall, Golden, Gregory LLP
  • John Avellanet , Managing Director/Principal, Cerulean Associates
  • Maxine K. Fritz , Executive Vice President of the Pharmaceuticals and Biologics Practice, Becker & Associates Consulting, Inc.
  • Gabrielle Cosel , Project Manager – Drug Safety Project, Pew Health Group
  • Sara Dyson , Assistant Vice President of Loss Control, Medmarc

Pharma Quality Advisor can be found at A one-year subscription costs less than $72 per month to ensure affordability for all Pharma Quality Managers.  Subscribers get:

  • Weekly updates on the latest GMP news and regulatory developments, enforcement updates and how-to resources
  • Webinar and conference sessions on pharma quality topics
  • How-to reports that tackle the toughest compliance challenges
  • References to pharma quality regulation and guidance

You can subscribe to Pharma Quality Advisor online with a secure order form at or call customer service at 1-888-838-5578 to arrange a free trial and to learn more about the product.

Media Contact: Dan Landrigan FDAnews, (888) 838-5578,

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