Wednesday, November 18, 2015

Robert Califf, F.D.A. Nominee, Queried on Industry Ties - The New York Times

Read the full report:  Robert Califf, F.D.A. Nominee, Queried on Industry Ties - The New York Times:

"President Obama’s nominee to lead the Food and Drug Administration, Dr. Robert M. Califf, coasted through a confirmation hearing on Tuesday, with most members of a Senate committee — including some who have been skeptical about his ties to the pharmaceutical industry — seeming set to support his candidacy."

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Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases | OPA | Department of Justice

Read the full press release: Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases | OPA | Department of Justice:

"Criminal Charges Brought against Bestselling Supplement Manufacturer

As part of a nationwide sweep, the Department of Justice and its federal partners have pursued civil and criminal cases against more than 100 makers and marketers of dietary supplements.  The actions discussed today resulted from a year-long effort, beginning in November 2014, to focus enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide.  In each case, the department or one of its federal partners allege the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence.

Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers.  USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro."

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Wednesday, November 11, 2015

Free GMP Training Tips - A Focus On Class Times & More

For optimal throughput, choose class schedules & format wisely.

Coordinate training schedules for maximum gain

Give some thought on how to minimize the impact on production and other critical daily work responsibilities. Unless your production lines are down, you'll want to make sure production quality doesn't suffer. For some, even though they're in class, their minds are elsewhere (distracted by what's waiting for them back at their desks). Try to limit putting extra demands & stress on staff (for example, a stressor such as asking staff to attend class before/after their normal work shift, especially if they work 3rd shift). Here are a few ideas:
  • Split it.  If the course is 8 hours long, split the classroom time in half, and conduct the class over a 2 day period.
  • Deliver training at some time other than regular shift hours (this might be obvious). And be sure to consider offering training on the weekend.

Choose the best format & venue

  • Chunk training into digestible sessions. It's important to create an effective learning experience. For content heavy topics or workshop courses, it might make sense to split it up to avoid full day training overload, and give a little time for homework or just a breather to let it all sink in. 
  • Sometimes you have no choice but to get very larger numbers of employees through training as fast as possible. One possibility is to use a large venue (for example, an auditorium or conference facility) to meet your training goals & objectives, and achieve the necessary training throughput.

Get a trainer that teaches at your desired times

The right training vendor will do their best to accommodate your unique site and staffing situation to deliver training courses at the times that work best for you. For example, explore having the trainer teach a class during 3rd shift or on the weekend.

Do these tips touch on your situation, and you need GMP training?

If you said yes:
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