Navigation Links
Pharma Quality Assurance: FDA Compliance Solutions for Pharma Quality Managers
Date:4/25/2013

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

(Photo: http://photos.prnewswire.com/prnh/20130425/CG00933)

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 www.PharmaQualityAdvisor.com/NewSubscriber. 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 www.PharmaQualityAdvisor.com/NewSubscriber 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, dlandrigan@fdanews.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE FDAnews
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Finds Utilizing Integrated Medical and Pharmacy Data Improves Ability to Forecast Use of High-cost Specialty Treatments
2. Report Presents a Framework for Successful New Oncology Product Launches in the Pharmaceutical Sector
3. WuXi PharmaTech Files 2011 Annual Report on Form 20-F
4. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
5. Pharmaceutical Industry Service Company Awarded The UKs Most Prestigious Business Accolade in Recognition of Outstanding Achievement in International Trade
6. Academy of Managed Care Pharmacy (AMCP) Installs 2012-2013 Board of Directors
7. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
8. Simcere Pharmaceutical Group to Announce First Quarter 2012 Financial Results on Wednesday, May 9, 2012
9. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
10. Thomson Reuters Launches New Mobile Oncology Decision Support Solution for R&D Pharmaceutical Leaders
11. Amgen to Acquire Mustafa Nevzat, a Leading Privately Held Turkish Pharmaceutical Company
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... -- , , , WHEN: , ... , , , LOCATION: , , , Online, with free ... EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice President ... Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... is witnessing an exceptional era. Several new demand spaces, such as ...
(Date:6/23/2016)... June 23, 2016  Guerbet announced today that it ... Supplier Horizon Award . One of 12 ... recognized for its support of Premier members through exceptional ... excellence, and commitment to lower costs. ... recognition of our outstanding customer service from Premier," says ...
(Date:6/23/2016)... , June 23, 2016 ... but it continues to present great opportunities to investors. ... for today: Intrexon Corp. (NYSE: XON ), ... Pharmaceuticals Inc. (NASDAQ: ARNA ), and Regeneron ... about these stocks and receive your complimentary trade alerts ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... ... Sessions in Dallas that it will receive two significant new grants to support ... as PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists ...
(Date:6/24/2016)... Francisco, CA (PRWEB) , ... June 24, 2016 ... ... CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive ... self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine ... Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor ... Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With this ...
(Date:6/24/2016)... Nevada (PRWEB) , ... June 24, 2016 , ... ... Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and processing operations ... in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a ...
Breaking Medicine News(10 mins):