Thursday, October 29, 2015

FDA Shows Up, a Man Runs, and Questions Emerge on China's Drugs - Bloomberg Business

Read the full article: FDA Shows Up, a Man Runs, and Questions Emerge on China's Drugs - Bloomberg Business:

"When FDA inspectors showed up at a Chinese company that supplies key ingredients to two of the U.S.’s biggest drug companies, a curious thing happened.

After lunch, they walked into a quality control lab on the second floor, where they saw a worker pull what looked like a memory stick from a computer and put it in the pocket of his lab coat. The inspectors asked to see what he’d taken.

And then the man turned and ran."

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Tuesday, October 27, 2015

Inspection Observations - FDA.gov

Go to this FDA webpage:  Inspections > Inspection Observations - FDA.gov:

"FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

Spreadsheets summarizing the areas of regulation cited on FDA's system-generated 483s are available by fiscal year on the menu links on this page. These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives. Turbo EIR is FDA's automated Form 483 reporting system. Turbo EIR is utilized to generate the FDA Form 483 when applicable cite modules exist. Not all FDA Form 483s are generated in TurboEIR as some 483s are manually prepared and not available in this format. Observations have been broken out by Product or Program Area on separate tabs of the spreadsheet. The Product and Program Areas include the following:

  • Biologics
  • Drugs
  • Devices
  • Human Tissue for Transplantation
  • Radiological Health
  • Parts 1240 and 1250"

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In fiscal year 2014, you'll notice that biologics and drugs areas were highly associated with some kind of sub-standard investigation.

You might also be interested in this workshop:


Root Cause Analysis for Better Investigations - a cGMP Training Workshop by SkillsPlus Intl Inc.

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Thursday, October 22, 2015

Accusations highlight special pharmacies - Business Insider

Read the full article: Accusations highlight special pharmacies - Business Insider:

"Whether you believe accounting fraud allegations levied against pharmaceutical-firm Valeant or not, one thing is certain.

The pain isn't over — not for Valeant, not for any company in the pharmaceutical industry.

That's because what's really at the heart of the accusations against Valeant is the use of a new, shadowy segment within the pharmaceutical industry: specialty pharmacies."

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Wednesday, October 21, 2015

Drug Firms Use Tor to Shop for Dark Web Fakes - Bloomberg Business

Read the full article: Big Pharma's Darknet Drug Deal - An Ex-Detective Is Tracking Down Knock-Offs To Counter A Dangerous Trade -  Drug Firms Use Tor to Shop for Dark Web Fakes - Bloomberg Business:

"For the $300 billion pharmaceutical industry, the rapid growth of such marketplaces is a serious threat to profits and reputations. For regular folks who turn to the darknet because they’re uninsured or their coverage won’t pay for expensive medications, the choice can be lethal. Counterfeit drugs bought online have been shown to include everything from gypsum and rat poison to heavy metals and household cleaners."

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Friday, October 16, 2015

Top Reasons In-Person GMP Training Can Be Best

Call SkillsPlus International Inc. for live on-site in-person cGMP training that's:

Flexible, & Interactive

  • You get to: pick the date, time, & location; adjust for shifts, or number of days that works best for your employees; select your facility, plant, training center, or other desired location. 
  • In-person training engages students. With the right instructor, on-site training: encourages interaction according to class size and level of training, ensures consistent messages, fosters team building, offers real-time help & support, and provides the important “human touch” (which is often missing in technology-based training). 
  • Group interaction enhances learning. Employees learn from one another as well as from the trainer. The group setting also teaches employees how to interact with one another in a professional, productive, cooperative way, which is something that other forms of training often don’t provide. 

 Customized For Your Needs

  • Your training needs are addressed. Training content & activities are adjusted, based on students’ prerequisite & current skill levels, and the organization’s specific needs, objectives, issues, and challenges. Tailoring the content ensures that training is unique & relevant. 
  • Confidential issues can be covered. Training on-site means you can candidly discuss your organization's unique challenges and opportunities. Sensitive company information can be shared by participants and used as concrete examples during interactive and workshop sessions in complete confidence. 

 A Great Value

  • You get live in-person expert instruction! The best on-site teachers are skilled facilitators and/or consultants. With the right instructor, you get the added advantage of getting expert advice right on the spot, and training that is engaging & fun.

 Take The Next Step

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Some people use the following descriptors to talk about live training: onsite, on-site, live, in person, in-person, customized, train more people, live classroom, person to person, face to face, instructor led, instructor-led, synchronous, traditional, personalized,in-class, conventional, classroom-based, live class, interactive teaching, regular classes, classroom training, real classroom, ILT, and instructor led training. 

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Tuesday, October 13, 2015

Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation

Read the full article: Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation:

"Ancestry.com, the popular genealogy site, is talking to the FDA about using DNA to estimate disease risk for the company’s member base. CEO Tim Sullivan revealed the news in an interview with The Verge, effectively announcing his company’s intention to eventually offer straight-to-consumer genetic testing.

Ancestry is currently in the "very early stages of a conversation with the FDA," Sullivan told The Verge. "We think it's totally appropriate that the FDA has stepped in to pretty aggressively regulate direct-to-consumer genetic tests—and we're just starting from that perspective, and trying to work very closely with them," he continued."

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Tuesday, October 6, 2015

Kopcha Selected to Head FDA’s Quality Office | Pharmaceutical Technology

Read the full article: Kopcha Selected to Head FDA’s Quality Office | Pharmaceutical Technology:

"Michael Kopcha, a pharma industry veteran with 25 years of experience in formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management, has been named the permanent director of FDA’s Office of Pharmaceutical Quality (OPQ), according to a Sept. 25, 2015 announcement by Janet Woodcock, director, Center for Drug Evaluation and Research (CDER). Kopcha will join CDER in November pending ethics clearance.

FDA’s OPQ was launched in January 2015 to implement processes and policies to provide better alignment among review, inspection, and research functions."

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FDA orders manufacturers to study cleaning problems with medical scopes linked to infections - The Washington Post

Read the full article: FDA orders manufacturers to study cleaning problems with medical scopes linked to infections - The Washington Post:

"The agency ordered a trio of manufacturers to conduct real-world evaluations on how well health care workers are cleaning and disinfecting the devices and what more might be done to prevent the spread of life-threatening infections.

Known as duodenoscopes, the devices are used in hundreds of thousands of procedures each year in the United States to drain fluids from pancreatic and bile ducts blocked by cancer tumors, gallstones and other conditions. Doctors consider them a key tool in detecting and treating medical problems in a minimally invasive way."

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Friday, October 2, 2015

Massive, unexpected drug price increases are happening all the time - Quartz

Read the full article & view graphics: Massive, unexpected drug price increases are happening all the time - Quartz:

"Valeant is the biggest standout. The Canadian company, a favorite investment of hedge fund icon Bill Ackman, has pursued a strategy of buying out other companies and drugs, slashing R&D budgets, and dramatically increasing prices. Its average price increase so far this year is 66%. Behind it are Allergan, Maltlinckrodt, and Mylan."

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Thursday, October 1, 2015

Trashed Tests Put FDA on Notice as China Pushes Drug Exports - Bloomberg Business

Read the full article: Trashed Tests Put FDA on Notice as China Pushes Drug Exports - Bloomberg Business:

"“It’s not just for the U.S. FDA, also the China FDA is understaffed as well,” said Jonathan Chan, an analyst in Hong Kong with Decision Resources Group, citing the size of the industry and the large number of drug applications. “It’s quite overwhelming. With agencies being understaffed, quality control and standards will get compromised.”"

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