Resources

I thought I’d share with you a few things that we believe will impact us immensely. They impact us because they impact you. 1. FDA inspectionsareundergoing a massive change. In 2015, approximately60% of inspections will happen overseas, and this trend will likely continue. Over time, I’d expect the FDA to eventually balance inspections based on […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> 5/1/2014 Cardinal Health 414 LLC Colton CA United States 6/17/2014 Cardinal Health 418, Inc. Aurora CO United States 6/20/2014 CareFusion 2200, Inc. Mannford OK United States 5/20/2014 CaridianBCT, Inc. Lakewood CO United States 6/25/2014 Cascade Medical […]

Yesterday was Part I. Today, we get to hear a little more from Barb on her background. What publicly available information do you depend on for your job? How do you use that information? I focus primarily on the US, EU, ICH and PIC/S. For laws, regulations and guidance the regulator specific websites publish information […]

Barbara Unger: I see four trends in drug GMP enforcement actions over the past couple of years and all reinforce FDA’s focus on patient safety and public health. The most visible trend for fiscal year 2014 warning letter enforcement actions was the focus on compounding pharmacies. These businesses received the majority of GMP warning letters […]

Is part of your job to prep your company for FDA inspections? Do you spend part of your week culling through various FDA, EMA, ICH, PIC/S and EMA-related websites tracking down changes in regulations, guidelines, and concept papers? Is the FDA ORA reading room bookmarked on your browser? If so, we are excited to […]

Sometimes we get emails from people who are just starting out in the field of regulatory, quality, and compliance, asking us – what advice do we havefor new people to get onto the right path? I turned to you on LinkedIn, and these are some of my favorite responses: It basically comes down to this.., […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> Inspection End Date Company City/Local State/Region Country 3/15/13 Paragon Research Center San Antonio TX United States 7/7/11 Patheon Inc. Whitby Canada 4/6/12 Peptido GmbH Bexbach Germany 2/27/13 Philips Burton Franklin Park IL United States 12/18/13 PureTek […]

Here are the featured FDA 483s for the week. You can obtain these at the FDAzilla 483s store here>> Inspection End Date Company City/Local State/Region Country 10/25/13 Glenmark Generics Limited Indore India 7/19/13 Glenmark Generics Limited Colvale Bardez India 1/31/13 GS Medical Packaging Inc Mississauga Canada 5/17/12 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd Hangzhou China […]

PRLog – Jan. 26, 2015 – CHICAGO — Today, FDAzilla announced the launch of a new GMP resource for quality, regulatory, and compliance professionals working in the pharm, biopharma, and select medical device industries. The FDA continues to increase its focus and attention on ensuring the safety of the drug supply in the U.S. Manufacturing […]

I find the typical approach to managing massive pharma compliance projects quite fascinating, particularly when it comes to problems that require a fundamental makeover. It reminds me of a three-ring circus. In the middle ring, management immediately starts to tackle the problem by doing what it does best: establishing layers of bureaucracy. The multiple layers […]