Regulatory Affairs Update; FDA 483 and Warning Letters Trends for 2012
Those of you who manufacture products approved by the US Food and Drug Administration (FDA) are well aware of the importance of complying with Current Good Manufacturing Practices (cGMP) during FDA mandated inspections of your manufacturing facilities. Failure to comply with cGMP requirements during an inspections results in the issuance of 483s. And if you fail to adequately address the concerns of the agency outlined in 483s, it may ultimately result in issuance of warning letter to your company.
FDA is more vigilant and aggressive than ever before with its 483 and warning letter enforcement procedures. In the words of Commissioner Margaret Hamburg, FDA is quick, visible and vigilant. With this in mind, it may be worthwhile to participate in a webinar offered by Expert Briefings.com entitled “Top Compliance Trends for 483 and Warning Letters for 2012—Based on Rare FDA Data.”
The webinar will be held on March 8, 2012 from 2:00-3:30 PM EST and Dennis Moore, Managing Partner, AUK Technical Services and a 28 year veteran FDA investigator will lead it.
Topics to be covered include:
- Top warning letter trends for 2012, such as more 806 enforcement
- The Top 10 QS 483 Observations for 2010 and 2011
- Most common quality system failures for drugs for 2010
- Top drug and device citations in 483s for 2010
- Top drug and device warning letter citations for 2010
- Total 2010 BIMO inspections for CDER, CBER, CDRH, and CVM
- Details on clinical investigator, sponsor/monitor and IRB audits for 2010
- Most common sponsor deficiencies for 2010
- The rising trend of ‘cease to market’ letters, one of which hit a NY pharma company in 2011
- The total number of 483s issued in 2010 and 2011 – an all time high
- Total CAPA 483 observations in 2010
- How long to receive a warning letter, based upon which offices issues it
- 483 inspection targets for drugs and devices for 2010, 2011, and 2012
- Total warning letters issued by drug and device category in 2010
- Which district offices write the most warning letters
- How long to receive a warning letter, based upon issuing office
- Warning letters issued by QS system for 2010
- 483s broken down by QS subsystem for 2010
- Warning letters by CFR section
- Top device 483 observations for 2010
- Details on process validation observations for 2010
- Design control 483 observations by category for 2010
- Click here to visit Expertbriefings.com.
Click here to visit Expertbriefings.com.
I hope to see (hear ?) you at the webinar!
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Chicago-based Abbott Laboratories 
Abbott Laboratories today 
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Abbott Laboratories today 
Mark Senak, author of the highly informative and well written Eye on FDA blog, 
In contrast with many of its competitors, which have layed off thousands of pharmaceutical employees over the past two weeks, Roche
The fourth 
The US Food and Drug Administration (FDA).jpg)
The 
Ed Silverman, over at the newly reinvigorated Pharmalot Blog, 
Novartis AG .jpg)
Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13th oh my). I wanted to attend and actually testify but I didn’t understand how the process works and blew my opportunity. However, I will be prepared for rounds 2 and 3 and beyond. I can assure you that this will not be the last public meeting organized by the agency to develop guidance for the use of social media in pharmaceutical marketing and advertising. 
For the past 10 years or so, I have been providing career counseling and development seminars and workshops for life scientists. In the early years, students, postdocs and a smattering of faculty members would attend to learn about industry trends, the job market and more recently, alternate careers for PhDs and postdoctoral fellows. However, over the last few years, a disturbing trend has emerged—the lack of 
I came across a 
Despite dire predictions, the biotechnology industry appears to be weathering the recession better than most. According to a
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BioJobBlog and 
Medtronics, the world's largest medical-device company, 
The US economy has lost about 7.1 million jobs since December 2007 and nationwide unemployment is hovering around 8.5 percent. Despite the lost of about 80,000 pharmaceutical jobs over the past three years and unprecedented consolidation taking place in the life sciences sector—Merck-Schering Plough, Pfizer-Wyeth and Roche-Genentech—the job prospects for scientists at biotech companies, medical devices and diagnostics, and government appear to be stronger than anticipated. While drug discovery and sales jobs may be scare, there are rapidly emerging opportunities in the fields of medical communications, regulatory affairs, biomanufacturing, clinical trials management , bioengineering, medical devices/diagnostics and website development and management.
As many of you know, the life sciences industry, one of the most highly regulated industries of the economy has been hesitant and reluctant to embrace social media to reach out to patients, physicians and the lay public. This is because the US Food and Drug Administration, specifically Division for Drug Marketing, Advertising and Communications (.jpg)
I want to let my readers know that a beta-version of 
An article in today’s New York Times
Siemens, the Germany engineering, electronic and healthcare company is planning to 
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day, my good friend Pete learned that he had prostate cancer. His prostate specific antigen (PSA) levels were slightly elevated over the past few years (they were in a gray zone that made a definitive diagnosis difficult without doing a biopsy). After being urged by his wife and urologist, he had the biopsy performed and, unfortunately, a diagnosis of prostate cancer was made. Hopefully, his cancer is localized to the prostate and will be easily treated via conventional therapies. As many of you may know, prostate cancer is easily treat and the cure rates high if it is detected early.