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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Monday, May 12, 2014

17 Awesome Resources on Micro-Learning - eLearning Industry

17 Awesome Resources on Micro-Learning - eLearning Industry:

"Micro learning is learning in small steps (contrary to the traditional approach of learning through hour-long courses). It is made possible with the aid of small, well planned, bite-sized chunks of units or activities (also called learning nuggets) that are short-term, digestible, and easily manageable. ...

Micro learning is going to be the future of learning. It is all set to transform how we learn both for our personal as well as our professional needs. We foresee micro learning tools evolving into an essential component of any enterprise learning toolbox. "

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You might also be interested in:
The cGMP Mini-Series - GMP multimedia teaching in bite-sized chunks (to use in your GMP training)

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Thursday, May 8, 2014

FDA > Drug Supply Chain Integrity > Verify Wholesale Drug Distributor Licenses

Follow the link below to see a list of the U.S. state agencies responsible for drug wholesaler licensing. The list is organized by: State, Agency Name, and Website Link or Contact Info.

Drug Supply Chain Integrity > Verify Wholesale Drug Distributor Licenses - FDA:

"U.S. State Agencies Responsible for Licensing Wholesale Prescription Drug Distributors" ...

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You might also be interested in drug wholesaler-related training & resources:
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc - Available around-the-clock 24 x 7 - Available for iPad
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

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I Like GMPs - PharmaManufacturing.com

I Like GMPs: Even if regulators didn’t require GMPs, I would follow the practices - PharmaManufacturing.com:

"Yes, regulators have set clear expectations for those of us in pharmaceutical manufacturing about calibrating and validating equipment; maintaining clean facilities; training qualified employees; and demonstrating that our processes are reliable and reproducible, and that our validation methods have been tested and re-tested.

But even if those expectations weren’t regulated, GMP is simply good business practice. We need to know what we are doing, how we are doing it, be able to document it, and then figure out how to make it all better. This is what any good businessperson does to keep the enterprise running smoothly and in the most profitable way possible. So in response to my fair colleague, who would abandon GMP if possible, I must humbly disagree."

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Wednesday, May 7, 2014

ASTD Reboots With New Name (ATD) and Logo

ASTD Reboots With New Name and Logo | 2014-05-06 | ePublishing:

"The American Society for Training and Development is changing its name to the Association for Talent Development. The announcement came from ASTD president and CEO Tony Bingham in a Tuesday afternoon event at the 2014 ASTD International Conference and Exposition in Washington, D.C.

“Now is the time for ASTD to adapt and meet you where you are, to align to where the profession is and where it’s going,” Bingham said. “This is a journey of redefining our brand and widening a path to a future that is grounded in the work you do in developing the talent of today and tomorrow.”"

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What To Do 15 Minutes Before A Presentation - Business Insider

Click the link below to see the 10 things you can do . . .

What To Do 15 Minutes Before A Presentation - Business Insider:

"Whether you're stepping to the front of the room to speak to just a few people, or making a grand entrance in a ballroom to address thousands, you can effectively use the time immediately before you go up to prepare your body and mind for peak performance, Price says.

Here are 10 things you can do in the 15 minutes before a big presentation to optimize your speaking success:"

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