GMP REGULATORY INTELLIGENCE

WE WORK HARDER SO YOU WORK SMARTER

Is your team focused on staying ahead of the trends?

If you want to accomplish your organizational goals with less manpower, you need to leverage resources like GMP Regulatory Intelligence. As the pharma industry’s only weekly synthesis of all GMP regulatory and enforcement developments, this newsletter keeps your team up-to-date on relevant trends while saving your team from spending countless hours trying to track down the info. We find your needle in the haystack.

FDAzilla GMP Regulatory Intelligence We've all been there before: going from site to site trying to track FDA laws, regulations, guidelines, and enforcement actions - it is a time-consuming and frustrating experience. The information is fragmented and sources can be unpredictable. Even worse, you have to filter out piles of unnecessary, unrelated information to find what you need.

If there was a way to get the key developments on a weekly basis, would that save you and your team a lot of time and headache? Of course. And there is a way.

EXACTLY THE RIGHT INFO EVERY WEEK

FDAzilla GMP Regulatory Intelligence Every week, you'll get the quick run-down of FDA, EMA, PIC/S and ICH:

  • New laws
  • Regulations
  • Guidance
  • Concept papers published or posted that week
  • You'll get updates on:

  • FDA warning letters
  • FDA drug recalls
  • FDA import alerts for drugs and selected devices
  • Eudra GMDP reports of non-compliance
  • Regulatory actions that published that week, including links to the source documents
  • You'll also be able to access links to the top stories in our industry. We read all those stories each week and handpick the ones that are most relevant to you. Plus, we’ll periodically provide special in-depth analyses and insights on newly published FDA data and trending issues. You will also receive a monthly synthesis to reinforce key trends.

    Meet Barbara Unger

    FDAzilla Barbara Unger GMP Quality Expert Meet industry veteran Barbara Unger. As the editor-in-chief of GMP Regulatory Intelligence and FDAzilla's GMP Quality Expert, she has been in your shoes.

    Most recently, she was the Director of External Quality for Amgen. There, she designed, developed, implemented, and managed a sophisticated and comprehensive GMP Regulatory Intelligence program for 8 years. A key part of that program was surveillance of the environment on a daily basis and communication of time-sensitive and business-critical information to relevant management and staff in real time. Her newsletter inside Amgen was distributed broadly across the company - from VPs to front-line quality, operations, development and regulatory personnel.

    Barbara has also been an industry leader in the area of GMP Regulatory Intelligence. Barbara was a leader in Rx-360, the pharmaceutical and device global supply chain consortium founded in 2009. She was the founding chairperson for the Monitoring and Reporting team that identified and published summaries of new and revised GMP and GDP laws, regulations and guidance that impacted the pharmaceutical and device industries. She led the group from its inception in 2009 through 2014. She was chairperson of the GMP Intelligence subgroup of the Midwest Discussion Group from 2010-2014.

    Let Barbara do the scanning, filtering, analysis, and synthesis for you! START SAVING YOUR TIME TODAY.

    Join Others Already Saving Time

    "We are all much busier in this day and age. This will be my main source for what's going on with regulatory changes and inspections affecting Pharma - It's concise, thorough, and current!"

    Principal Corporate GMP Auditor, Global Biopharma Company

    "An excellent source of timely information necessary to keep current with the regulatory/compliance environment, recent inspection trends, and hot topics"

    GMP Consultant to the Biopharma Industry

    "I find this very helpful -- currently I spend my days tracking this kind of news down. To find it all in one place is great."

    See available plans that include GMP Regulatory Intelligence. Email sales@FDAzilla.com for corporate options.

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