Monday, July 30, 2012

Highly Recommended QSR Trainer & GMP Trainer Certification

Updated May 6, 2014:


Did you miss our public seminar? We also offer this program as an on-site course conducted at your location. Give us a call: (415) 948-5220, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm
---

Highly Recommended QSR & GMP Trainer Certification | SkillsPlus International Info:

"GMP & QSR Trainer Certification Program
(offered as a public seminar Oct 22-26, 2012 in San Francisco, CA)

Refine your skills and become the best QSR or GMP trainer that you can be!

Learn about things to do in San Francisco:  San Francisco Travel for Visitors

This is a five-day class where participants experience many different ways to teach CGMPs and QSRs. Then learn what your instructor is thinking about during sessions so that you can repeat that training approach in your organization. Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also."

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Learn more about about: cGMP/QSR Trainer Certification Program


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Sunday, July 29, 2012

Global AIDS Conference Wraps Up

Global AIDS Conference Wraps Up:

"Michel Sidibe, the executive director of the United Nations Program on HIV/AIDS said there needs to be more cure research.

"Today we should not just say, 'okay, let us have treatment.'  We should say, 'why not a cure?  Why not a vaccine?' That is the area where we need to put our energy, and that will bring us certainly to the end of this epidemic," he said.

Activists disrupted sessions and panels to demand greater funding and resources for research and for those living with HIV and AIDS. "We can end AIDS!  We can end AIDS!" were among the slogans heard at the gathering."

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For more information:  AIDS 2012 Home

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Wednesday, July 25, 2012

An Internal Failure To Innovate Is America's Greatest Global Threat - Biopharmaceuticals

"The $900 billion U.S. biopharmaceutical industry is a critical force in the U.S. economy. It supports some four million American jobs, including more than 650,000 jobs in the industry itself. The average biopharma wage is nearly twice the U.S. private sector average, $119,000 versus $64,000 – reflecting the value created by pharmaceutical innovation."

An Internal Failure To Innovate Is America's Greatest Global Threat - Forbes:

"Just this month, we learned that the U.S. dropped to 10th place in the 2012 Global Innovation Index, down from 7th place the year before. The index, published by the international business school INSEAD and the World Intellectual Property Organization, ranks 141 nations on nearly 100 factors related to innovation; the top two countries, for two years running, are Switzerland and Sweden.

The report said the biggest area of concern for the U.S. was a drop in “human capital and research” – which includes K-12 and college education, as well as R&D.  In these areas so critical to future innovation, the U.S. ranking fell from 13th in 2011 to 22nd this year."

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Tuesday, July 17, 2012

FDA's Unique Device Identification (UDI) System - Free FDA Video

FDA's Unique Device Identification (UDI) System:  <--- follow this link to the FDA's free video

"FDA has issued a proposed rule on the establishment of a Unique Device Identification System. This system would require most medical devices distributed in the U.S. to carry a Unique Device Identifier (UDI). This system, comprised of the UDI code, application of the UDI to device labeling and packaging, and a related database, is designed to provide a standardized way to identify devices across all information sources and systems, including electronic health records and devices registries."

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FDA approves first drug for reducing the risk of sexually acquired HIV infection

This is considered pivotal in the 30-year battle against AIDS.

Press Announcements > FDA approves first drug for reducing the risk of sexually acquired HIV infection:

"Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.

The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.

As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing."

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Monday, July 16, 2012

Fat-melting device a weighty matter for FDA - It has not been approved

Fat-melting device a weighty matter for FDA - Open Channel:

"But there’s a problem: The LipoTron, which targets fat with radiofrequency waves, has never been cleared or approved by the U.S. Food and Drug Administration, which would make it illegal under federal law to sell or promote it for weight loss.

The FDA is aware of the activity. But an investigation by FairWarning found that the agency has not taken enforcement action — even though it has known about the situation at least since January, 2010. At that time, two whistleblowers, one a former LipoTron distributor, provided sales records and a trove of other documents to an FDA criminal investigator."

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Essentials for Medical Device Manufacturers - The best basics QSR training course available

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Sunday, July 15, 2012

FDA Surveillance of Scientists Spread to Outside Critics

Really kind of surprising.

What's worse is that some of the information and documentation inadvertently got exposed on the web.

F.D.A. Surveillance of Scientists Spread to Outside Critics - NYTimes.com:

"What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort."

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Saturday, July 14, 2012

Changes Coming to FDA QSR for Prefilled Injection Devices

Manufacturers of prefilled drug delivery devices and their components need to begin preparing for compliance with the coming quality system regulation for combination products.

The following article is a very well written analysis of the situation, with very practical recommendations on how to get ready for the necessary changes.

Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices > RAPS > Features - Article View:

"The rule is expected to require combination product manufacturers to comply with both Current Good Manufacturing Practice regulations for drugs and biologics (21 CFR 210, 211 (CGMP)) and the Quality System Regulation for medical devices (21 CFR 820 (QSR)), during and after formation of a combination product. This has significant implications for pharmaceutical and medical device manufacturers that produce medicated devices, prefilled drug delivery devices and their components."

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Olympics for Medical Device Manufacturers - Exciting & Fun QSR Training

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Friday, July 13, 2012

Working With The FDA - The FDA Warning Letter Process

A nice quick and easy introductory article about FDA Warning Letters.

Working With The FDA | Pharmaceutical Processing:

"According to FDA, warning letters are sent as a way of encouraging companies to voluntarily comply with industry standards and regulatory guidelines. In that regard, they are a way of establishing a public record of the agency’s conversations with members of the industries it regulates.

Generally warning letters are sent following a routine or complaint-triggered inspection. Upon completion of an inspection, investigators may issue Form FDA-483 which documents any deficiencies found at a facility. Company officials will then be able to initially respond either through an exit discussion and/or a formal written response. Agency inspectors will also draft an Establishment Inspection Report (EIR), providing more detail on inspection observations and linking them to any evidence collected from the affected firm’s facility. Once the EIR and Form 483 are reviewed by senior FDA officials, a warning letter may follow."

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Surviving an FDA Inspection - A highly recommended training course taught by the best instructors

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Wednesday, July 11, 2012

Good Manufacturing Practices Creative Ideas for Teaching GMP - Free Tip

Good Manufacturing Practices Creative Ideas for Teaching GMP By Madison Area Technical College Biotechnology Department Back To GMP:

"Documentation, that is, a system of written records, is essential in all laboratories and production environments. A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use."

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Procedure Writing for Greater Process Control - a popular training course

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Tuesday, July 10, 2012

When Does An App Need FDA's Blessing?

When Does An App Need FDA's Blessing? : Shots - Health Blog : NPR:

"As a result, the Food and Drug Administration has concluded that at least some apps should undergo review by the agency before being permitted on the market. "There are many mobile apps that are on the market that are medical devices," Dr. Jeffrey Shuren, who heads the FDA's Center for Devices and Radiological Health. "There are apps today that change a mobile platform into an EKG machine. When it's being used to diagnose patients, it's a medical device we believe subject to FDA oversight."

But Shuren stresses that the FDA has no plans to review most apps, such as those that help with wellness, healthier lifestyles. Same goes for thoseused to help patients manage their medical conditions. "The risk to patients are very, very low," he says.

Some app makers, however, say they can't be sure what's allowed. "The problem is now we live in this era of connected health where everything is being connected to everything else," said Bradley Merrill Thompson, a lawyer who represents some app makers. "So now that you've got this ecosystem where everything is connected to everything else. That's what creates this ambiguity with FDA.""

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You might also be interested in:
Essentials for Medical Device Manufacturers - Recommended QSR training

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Highly Recommended QSR & GMP Trainer Certification - SkillsPlus International Inc.

Updated May 6, 2014:


Did you miss our public seminar? We also offer this program as an on-site course conducted at your location. Give us a call: (415) 948-5220, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm
---

Highly Recommended QSR and GMP Trainer Certification | SkillsPlus International Info:

"GMP and QSR Trainer Certification Program
(offered as a public seminar Oct 22-26, 2012 in San Francisco, CA)

Refine your skills and become the best QSR or GMP trainer that you can be!

Learn about things to do in San Francisco:  San Francisco Travel for Visitors

This is a five-day class where participants experience many different ways to teach CGMPs and QSRs. Then learn what your instructor is thinking about during sessions so that you can repeat that training approach in your organization. Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also."

'via Blog this'

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Saturday, July 7, 2012

FDA Consumer Updates - Should You Put Sunscreen on Infants? Not Usually

FDA Consumer Updates > Should You Put Sunscreen on Infants? Not Usually:

"You're at the beach, slathered in sunscreen. Your 5-month-old baby is there, too. Should you put sunscreen on her? Not usually, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

"The best approach is to keep infants under 6 months out of the sun," Sachs says, "and to avoid exposure to the sun in the hours between 10 a.m. and 2 p.m., when ultraviolet (UV) rays are most intense.""

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What is the Cost of GMP Compliance?

Updated September 26, 2016

The original link below didn't age well, and is broken.

You might also be interested in:
Instant GMP Compliance Series for Dietary Supplements – Cost of Compliance

- -  the original post follows below  - -

Equally important is the question, what does non-compliance end up costing?

What is the Cost of GMP Compliance?:

"What does your company spend on compliance with Good Manufacturing Practices?  Is it more than the FDA estimates?

FDA's Cost of Compliance Calculation

The FDA calculated how much record keeping for GMP manufacturing would cost after their 2003 DSHEA act went into effect.  Here is what they projected:" . . .

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Friday, July 6, 2012

5 grilling mistakes that pose a danger to your health

Of the 5 mistakes, I'm intrigued by #3, so I'm sharing it with you . . .

5 grilling mistakes that pose a danger to your health - Health & wellness - The Boston Globe:

"Spraying on Pam after the grill is already lit. I admit I’ve done this occasionally even as I watch the flames surge with every spray. It’s a real burn hazard, said Kosowsky. Those non-stick cooking sprays should be sprayed on before lighting. If you’re spraying on sunscreen or bug spray while outdoors, make sure you’re standing at least 10 feet away from the grill to avoid the blowtorch effect."

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Minnesotans worry pending FDA bill prohibits imported prescription drugs



 Minnesotans worry pending FDA bill prohibits imported prescription drugs | kare11.com:

 "It is designed to increase inspections of foreign drug factories, while also speeding approvals of new drugs at home. Lee Graczyk heads up an affordable prescription advocacy group based in the Twin Cities, RxRights, and says Section 708 of the bill is troubling for the nearly 14,000 Minnesotans who order drugs from other countries - himself included. "That is because Section 708 allows the Secretary of Health and Human Services to determine that any imported medicine valued at $2,500 or less may be seized and subject to destruction, without reimbursement or replacement," he said, adding a length appeals process could follow."

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FDA Plans IDs to Track Medical Device Safety

It's kind of a twist to think of tracking medical devices like cars and toasters . . .

FDA Plans IDs to Track Medical Device Safety:

"Medical devices like hip implants and heart defibrillators will soon join the ranks of cars and toasters.

The U.S. Food and Drug Administration on Tuesday proposed a new rule that would require each medical device to have a unique code that could improve tracking and catch safety problems earlier. The proposal comes five years after Congress first mandated the codes.

While these codes are already present for most consumer goods, in the ubiquitous barcodes scanned at the grocery store, they have been absent from life-sustaining medical devices."

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Thursday, July 5, 2012

How Congress almost delayed the FDA’s mobile medical app guidance

I can't wait to see what's in the final guidance, when it's finally published.

How Congress almost delayed the FDA’s mobile medical app guidance | mobihealthnews:

"Much has been written in the past few weeks about Congress’ efforts to put its mark on the FDA’s regulation of mobile medical apps. I was curious how this issue of 510(k) clearance for mobile apps became a topic of interest for Congress. The FDA published its draft guidance a year ago now. After hundreds of companies weighed in with their thoughts on the document, the industry widely expects a final guidance document any week now. Why did the Senate take an interest in medical app regulation this past spring? Who asked them to? And, what exactly did their conversation sound like?"

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FDA warns companies to stop making unapproved oxycodone painkiller pills

Companies have been doing what?!

FDA warns companies to stop making unapproved oxycodone painkiller pills - The Washington Post:

"The Food and Drug Administration says it will begin cracking down on companies that market versions of the painkiller oxycodone which have not undergone federal review.

Oxycodone is a powerful pain reliever with the potential for addiction, abuse and death, when used inappropriately. The drug is marketed legally by companies like Purdue Pharma, which sells the time-release pill OxyContin. FDA reviews these drugs to make sure they are safe and effective.

However, other companies have marketed similar pills for years without FDA clearance."

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Wednesday, July 4, 2012

FDA - Eating Outdoors, Handling Food Safely - Free Tips

Excellent advice from the FDA.  Simple and straightforward tips for outdoor food safety.

Consumers > Eating Outdoors, Handling Food Safely:

"Picnic and barbecue season offers lots of opportunities for outdoor fun with family and friends. But these warm weather events also present opportunities for foodborne bacteria to thrive. As food heats up in summer temperatures, bacteria multiply rapidly.

To protect yourself, your family, and friends from foodborne illness during warm-weather months, safe food handling when eating outdoors is critical. Read on for simple food safety guidelines for transporting your food to the picnic site, and preparing and serving it safely once you've arrived."

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Dietary supplements: Manufacturing troubles widespread, FDA inspections show

The FDA began conducting inspections in 2008 to assess compliance with new regulations governing the manufacturing, packing and holding of dietary supplements. Since then, 1 in 4 dietary supplement companies inspected by the agency have received a warning letter, considered a significant enforcement action.

Dietary supplements: Manufacturing troubles widespread, FDA inspections show | McClatchy:

"Federal inspections of companies that make dietary supplements - from multivitamins and calcium chews to capsules of echinacea and bodybuilding powders - reveal serious and widespread manufacturing problems in a $28 billion industry that sells products consumed by half of all Americans.

In the last four years, the U.S. Food and Drug Administration has found violations of manufacturing rules in half of the nearly 450 dietary supplement firms it has inspected, according to agency officials.

The inspection reports portray an industry struggling to meet basic manufacturing standards, from verifying the identity of the ingredients that go into its products to inspecting finished batches of supplements.

Some firms don't even have recipes, known as master manufacturing records, for their products."

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Tuesday, July 3, 2012

RAPS - Open Access Month - Free July Access to Regulatory Focus Online

What a treat!  I'm looking forward to exploring Regulatory Focus.

RAPS > Focus Online > Open Access Month:

"If you are a RAPS member, you already enjoy access to all Regulatory Focus news and in-depth features.

But if you aren’t a member, now is the chance to see what you are missing.

For the month of July, all articles – news, features and departments – are open for all to read. This is your opportunity to get information and insight from regulatory insiders on topics that affect you."

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