Thursday, August 21, 2014

Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post

Read the full article: Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post Business Page, Business News:

"The breaches have forced companies to boost efforts to protect their computer banks. On average, health-care companies spent $2.2 million on information security in 2013, a more than 20 percent increase from the prior year, according to a PwC, CIO and CSO magazine survey.

“I recently met with three CEOs in health care and in most cases they had come to the conclusion that they definitely did under-invest,” said Mick Coady, a partner at PwC’s health information privacy & security group. “Health care is at least a decade, if not more, behind.”"

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Monday, August 18, 2014

FedEx Faces Money-Laundering Charge in Revised Indictment - Bloomberg

Read the full article: FedEx Faces Money-Laundering Charge in Revised Indictment - Bloomberg:

"The allegations of a conspiracy to launder money were included in a revised indictment against the company filed today in federal court in San Francisco. FedEx and individuals who ran the illicit pharmacies “knowingly and intentionally” schemed to launder more than $630,000 in shipping payments that were derived from drug sales, federal prosecutors said in the indictment.

The government has said that FedEx and its co-conspirators could face a fine of twice the gains from the conduct, alleged to be at least $820 million."

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Wednesday, July 23, 2014

Short Video Clips For Your cGMP Training Content


cGMP Mini-Series: New training resources for training designers

What is the "Mini-Series"

Today, many trainers are developing their own e-learning courses and PowerPoint presentations. Developing collateral material to make these programs interesting is very time-consuming.

SkillsPlus has developed these short video resources which can be plugged into PowerPoint presentations, added to e-learning courses, or uploaded to learning management systems. Use them to reinforce YOUR teaching point!

These short six to ten minute segments are designed to entertain and teach a simple key learning message. Watch our abbreviated video previews or request a full program review by sending us an email with your name and telephone number to austin.lee@skillsplusinc.com


Overcoming Documentation Problems in the Pharmaceutical Industry

Part 1 - Plain and Simple - In the first segment titled "Plain and Simple," the student explores common documentation problems experienced in many pharmaceutical companies. David Wiley, playing the role of an FDA inspector clarifies how the FDA interprets such documentation problems. Barbara Atwater, Vice-President of Quality for Qualstar Pharmaceutical reinforces the importance of following procedures.
Part 2 - It's Happening All The Time Around Here - In the second segment titled "It's Happening All The Time Around Here," David Wiley explores additional unacceptable documentation practices found in a variety of different records in the pharmaceutical industry. The focus of David's comments in this section is blank spaces in documents. Barbara clarifies the proper technique for handling blank spaces in records.
Part 3 - What's In Your Hand? - In the third segment titled "What's In Your Hand?" David Wiley clarifies the expectations of the FDA with regard to capturing information in control documents. In this segment Barbara identifies several reasons for failing to properly document employees work.
Part 4 - Correcting Those Errors - In the fourth segment titled "Correcting Those Errors," David Wiley identifies several unacceptable error correction practices in the pharmaceutical industry. In this segment Barbara clarifies the rules as applied at Qualstar Pharmaceutical for correcting errors in documents.
Part 5 - Out The Gate Before You're Eight - In the fifth segment titled "Out The Gate Before You're Eight," David Wiley discusses the concerns the FDA has when they discover falsified information and documents. Barbara clarifies the Qualstar practice, and common industry consequences for falsification and records. 
Pricing

This five-part series is $450 plus tax and shipping (no shipping for downloads) and it includes all five movies. The movies arrive in the following file formats to assure maximum flexibility in how you might use them: WMV, SWF, FLV or AVI file formats. To place your order call us today at (415) 487-3500 or (954) 873-7422.

Licensing Limitations:
Your license permits you unlimited use of these materials within your plant site. Call us if you need a global license. The use of these materials in consultant contracted services or the use of these materials in other for-sale-products is strictly prohibited. Consultants and training material developers developing materials for resale must call for special arrangements.

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Tuesday, July 22, 2014

FDA Abroad - Pharmaceutical Executive

Read the full article: FDA Abroad - Pharmaceutical Executive:

"In India, America's second largest global source of API and finished drug products, some 1,965 manufacturing facilities export to the US, but only around 600 sites are registered with CDER, said Atul Agrawal, supervisory consumer safety officer at FDA's India office. Drug manufacturing capability in India doubled to represent 12% of total US drug imports in 2012, up from 6% in 2008. "India is a major player in the prescription drugs Americans take on a daily basis," said Agrawal, much to the envy of Chinese nationals everywhere. And yet, FDA's operation in India currently consists of five full-time Americans, and two locally employed staffers, spread across two offices, one in New Delhi and one in Mumbai."

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Wednesday, July 16, 2014

U.S. Seeks Legislation to Curb Offshore Tax Deals - Bloomberg

Read the full article: U.S. Seeks Legislation to Curb Offshore Tax Deals - Bloomberg:

"In a letter calling for a “new sense of economic patriotism,” Treasury Secretary Jacob J. Lew said Congress should approve tax changes retroactive to May.

“We should prevent companies from effectively renouncing their citizenship to get out of paying taxes,” Lew wrote in the letter to top congressional tax writers, which was dated yesterday and obtained by Bloomberg News. “We should not be providing support for corporations that seek to shift their profits overseas to avoid paying their fair share of taxes.”

The mergers used to legally avoid taxes, known as inversion transactions, have become increasingly popular over the past year, particularly in the pharmaceutical industry. "

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Tuesday, July 15, 2014

FDA Gives Guidance On Compounding For Human Use - mondaq

Read the full article: FDA Gives Guidance On Compounding For Human Use - Food, Drugs, Healthcare, Life Sciences - United States - mondaq:

"In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human use. These documents are:
  • Draft Interim Guidance setting forth FDA's current thinking as to its interim expectations for outsourcing facilities regarding compliance with Current Good Manufacturing Practices (CGMP) until regulations are developed; 
  • A Proposed Rule adding 25 new drug products to the "do-not-compound" list, for both traditional compounders and outsourcing facilities; 
  • Final Guidance for traditional compounders; and 
  • Two separate requests, one for 503A and one for 503B, to nominate bulk drug substances for FDA lists of active bulk substances that traditional compounders and outsourcing facilities are permitted to use."
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Wednesday, June 25, 2014

Nanotechnology > FDA Issues Three Final Guidances Related to Nanotechnology Applications in Regulated Products, Including Cosmetics and Food Substances

Follow the link below to a webpage that contains links to the 3 final guidances.

Read the full article: Nanotechnology > FDA Issues Three Final Guidances Related to Nanotechnology Applications in Regulated Products, Including Cosmetics and Food Substances - FDA.gov:

"In June 2014, FDA issued three final guidance documents reflecting FDA’s current thinking on certain issues related to the use of nanotechnology in FDA-regulated products. FDA prepared these final guidances after taking into account public comment received on the corresponding draft guidance documents previously issued in 2011 and 2012. These guidance documents are being issued as part of FDA’s ongoing implementation of recommendations from FDA’s 2007 Nanotechnology Task Force Report."

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Monday, June 23, 2014

Pure Food and Drug Act passes in Congress, June 23, 1906 - POLITICO.com

English: Theodore Roosevelt, circa 1902
English: Theodore Roosevelt, circa 1902 (Photo credit: Wikipedia)
Read the full article: Pure Food and Drug Act passes in Congress, June 23, 1906 - Andrew Glass - POLITICO.com:

"On this day in 1906, the Pure Food and Drug Act cleared a hurdle toward its passage when the House and Senate both endorsed a joint conference committee report favoring the bill. The House vote was 240-17. President Theodore Roosevelt signed the landmark Progressive Era legislation into law on June 30.

The statute for the first time regulated food and drugs that moved in interstate commerce and forbade the manufacture, sale or transportation of poisonous patent medicines. It arose, with strong White House support, in the wake of exposés by such muckrakers as Upton Sinclair and Samuel Hopkins Adams."

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Friday, June 6, 2014

SecuringIndustry.com - USP starts field trials of FDA fake drug screening device

Read the full article: SecuringIndustry.com - USP starts field trials of FDA fake drug screening device:

"The US Pharmacopeial Convention has started field testing a new low-cost screening device designed to detect counterfeit and poor quality medicines quickly.

The handheld CD-3+ unit - originally developed by the US Food and Drug Administration (FDA) - uses multiple light sources to look at packaging using different wavelengths and provide images that can be interpreted by the user to differentiate between genuine and falsified medicines. The approach may also be applicable to individual tablets."

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Monday, June 2, 2014

FDA launches openFDA to provide easy access to valuable FDA public data

Read the full article: Press Announcements > FDA launches openFDA to provide easy access to valuable FDA public data:

"Today, the U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.

In alignment with the recent Presidential Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative, openFDA will make the FDA’s publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis."

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Go to: openFDA

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Thursday, May 22, 2014

Improving Documentation of GMP Procedures - Natural Products Insider

Follow the link below to read Richard Soltero's full article, written for dietary supplement manufacturers.

Improving Documentation of GMP Procedures - Natural Products Insider:

"Here are a few key GMP guidelines that help manufacturers avoid FDA citations and sanctions:
  • Document all procedures in manufacturing operations.
  • Maintain all records for plant and equipment cleaning processes.
  • Mandate techniques for product sampling.
  • Ensure approval by QC personnel for all procedures, tests, controls and deviations.
  • Implement a control process for product labeling.
  • Require QC personnel to provide results of initial or final products.
  • Provide a procedure to follow if documented specifications are not met.
  • Retain all written documentation for at least one year past the shelf life of the product or two years past the dissemination date of the last batch of dietary supplements."
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You might also be interested in:
Overcoming The Documentation Nightmare - A training course on proper documentation practices

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Friday, May 16, 2014

Warning Letters (2012 – Q1 2014) Show FDA’s GMP Enforcement Shifting Overseas | IPQ Newsletter

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention | IPQ Newsletter:

"In 2012, for the first time, foreign warnings began outpacing those issued domestically. Between 2012 and the first quarter of 2014, 48 drug GMP warning letters were issued internationally compared to 44 in the U.S. [Editor's Note:  At the end of the story is a chronological listing of all 92 of the drug GMP warning letters issued between the beginning of 2012 and the first quarter of 2014, categorized into U.S. and International. The key concerns that each of the warning letters address and links to the letters themselves are provided.]"

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