Friday, April 22, 2016

Priorities – Teamwork to Achieve Common Goals | FDA Voice

Read Dr. Califf's Priorities – Teamwork to Achieve Common Goals | FDA Voice:

"With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work for the nation and its citizens. During my vetting process I received hundreds of emails and had almost as many conversations with a large and diverse group of stakeholders. Over the course of these discussions, a recurring theme emerged: namely, that setting priorities would be critical to success."

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Wednesday, March 23, 2016

FDA Approved 3D Printed Drug Available In The US - Forbes

Read the full article: FDA Approved 3D Printed Drug Available In The US - Forbes:

"To create the 3D printed Spritam, all the elements are assembled layer-by-layer without compression or traditional molding techniques. Thin layers of powdered medication are then repeatedly spread on top of one another, as patterns of liquid droplets are printed onto selected regions of each powder layer. Interactions between the powder and liquid bond the materials together at a microscopic level."

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Wednesday, February 24, 2016

Wednesday: FDA commissioner | TheHill

Read the full post:  Wednesday: FDA commissioner | TheHill:

"The Senate will take a final vote Wednesday on President Obama's nominee to lead the Food and Drug Administration.

The vote on Robert Califf's nomination to be the next FDA commissioner comes after senators overwhelmingly agreed to end debate on the nomination Monday in a 80-6 procedural vote. "

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Monday, February 22, 2016

Robert Califf Senate vote could clear path to top FDA job - STAT News

Read the full article: Robert Califf Senate vote could clear path to top FDA job - STAT News:

"In a move designed to circumvent opposition to Califf, who was nominated in September, Senate Majority Leader Mitch McConnell has scheduled a procedural vote for Monday afternoon. If Califf wins the support of at least 60 senators in that vote, he would move on to a final confirmation vote — likely Tuesday — and his Senate opponents would lose their leverage to stop him."

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Tuesday, February 9, 2016

Major shift ahead in how FDA regulates drug quality: PwC

FDA Drug Quality Report - Major shift ahead in how FDA regulates drug quality: PwC:

"Parts of the pharmaceutical industry continue to struggle with drug quality. A major shift in the way the FDA oversees drug quality could pose new challenges for companies with inadequate control over their manufacturing facilities and supply chains."

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Read the PwC report:
Major shift ahead in how FDA regulates drug quality (PDF)

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An Update on the Nomination of FDA Commissioner Robert Califf - Policy and Medicine

Read the full report: An Update on the Nomination of FDA Commissioner Robert Califf - Policy and Medicine:

"An increasing number of senators are threatening to block Dr. Robert Califf's nomination to be the next Commissioner of the U.S. Food and Drug Administration. The story illustrates an unusual coalition of right and left-leaning members of the Senate, and common refrains about "industry ties" in government and medicine. Ultimately, arcane Senate rules allow the entire process to be stalled by these individual members of the body."

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Tuesday, February 2, 2016

Thursday, January 21, 2016

FDA To Inspect Facilities Using Novel Sterilization Methods

The FDA has released this guidance document:

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff
"We believe that novel sterilization technologies carry a substantial risk of inadequate sterility assurance if not conducted properly. Consequently, compliance with GMP for devices sterilized using these technologies should be closely evaluated. Failure to assure sterility presents a serious risk to human health because of the risk of infection. Therefore, we intend to inspect the manufacturing facility before clearing a 510(k) for a device that is sterilized by a novel sterilization process. Inspecting the manufacturing facility for devices sterilized using these sterilization technologies will help ensure the safety and effectiveness of these devices and mitigate the risks to human health."
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Saturday, January 16, 2016

FDA outlines cybersecurity recommendations for medical device manufacturers

Read the full article:  Press Announcements > FDA outlines cybersecurity recommendations for medical device manufacturers - FDA.gov:

"The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market. The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential cyber threats."

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Read the FDA draft guidance:
Postmarket Management of Cybersecurity in Medical Devices (PDF)

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Thursday, January 7, 2016

FDA - Proposed 2016 Guidance Development & Focused Retrospective Review of Final Guidance

According to the FDA:

" . . .guidance documents that CDRH intends to publish this fiscal year (FY2016), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn. We have provided three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents that issued in 2006, 1996, 1986, and 1976 subject to focused retrospective review."

Go to this FDA webpage:
CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance


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Saturday, January 2, 2016

F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval - The New York Times

Read the full article: F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval - The New York Times:

"In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and a passion to fight the disease that patient advocates thought he lacked."

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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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#FDA #cGMP #GMP #training

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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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Thursday, October 29, 2015

Root Cause Analysis For Better Deviation Investigations - Our Most Popular cGMP Training Workshop

A GMP Training Workshop - Root Cause Analysis For Better Deviation Investigations

Still true after so many years . . . One of the top reasons for a company to receive a 483 is a deficiency in the deviation investigation process.

In our onsite hands-on workshop, employees learn the most effective tools to determine the real root cause of the problem. Attendees use actual plant deviations to practice the use of the tools.

Allan Dewes (principal trainer - SkillsPlus International Inc.) has taught this course all over the world with exceptional results.

This workshop is typically paired with another workshop for the best training results:
Writing Deviation Investigation Reports - A SkillsPlus Intl Inc. cGMP training workshop

Call Allan now for a quote:  (415) 948-5220, or
Visit the SkillsPlus International Inc. website

 #FDA   #QSR   #cGMP   #GMP   #training #popular

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Tuesday, October 27, 2015

FDA Law Blog: Do You Really Want to Be An Executive In An FDA-Regulated Company?

Read the full article: FDA Law Blog: Do You Really Want to Be An Executive In An FDA-Regulated Company?:

"Appropriate to the forum, he focused on the industries regulated by FDA.  The emphasis he gave to the requirements for settling civil and criminal cases brought against organizations gives sharp focus to the problem of doing business when governed by a law that operates with a malum prohibitum standard of liability, a law that permits findings of criminal guilt without proof of intent or guilty knowledge."

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You might also be interested in this course for cGMP leadership and top management:
Executive Session: What Leadership Needs to Know - GMP Training by SkillsPlus Intl Inc.  

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Tuesday, October 20, 2015

GMP Training Tips For Modern Learners

cGMP Training - Free Tips For Training Modern Learners

GMP trainers need to be ready for the students of today.

Here are a few training strategy tips for teaching "modern learners."

  • They've got so much to do, they're pulled in many directions, and they can't pay attention to you - TIP:  Craft topics & course titles that are truly useful and valuable to these students. Design courses that are shorter, concise, and to the point. 
  • They're glued to their devices, constantly pinged & pinging - TIP: Grab and keep their attention through interaction and activities.
  • They absorb information quickly - TIP: Try to share information visually and graphically for better recall.

Need more help? Then call Allan Dewes (principal trainer at SkillsPlus Intl Inc.) because of his:

  1. established track record (working with myriad pharma-biotech clients)
  2. subject matter expertise (cGMPs, QSR, and more)
  3. mastery of the classroom and students

#FDA #cGMP #QSR #GMP #training #courses #classes #live #onsite

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