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."
'via Blog this'
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Wednesday, November 18, 2015
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."
'via Blog this'
#FDA #cGMP #GMP #training
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Wednesday, November 11, 2015
Free GMP Training Tips - A Focus On Class Times & More
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:- Learn more about cGMP training courses taught by SkillsPlus International Inc.
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Thursday, October 29, 2015
Root Cause Analysis For Better Deviation Investigations - Our Most Popular cGMP Training
Updated June 12, 2025
The referenced courses are no longer available as live workshops.
--- the original post follows below ---
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.
This workshop is typically paired with another workshop for the best training results:
Writing Deviation Investigation Reports - A SkillsPlus Intl Inc. cGMP training workshop
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
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.
This workshop is typically paired with another workshop for the best training results:
Writing Deviation Investigation Reports - A SkillsPlus Intl Inc. cGMP training workshop
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
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."
'via Blog this'
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
"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."
'via Blog this'
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Tuesday, October 20, 2015
GMP Training Tips For 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:
- established track record (working with myriad pharma-biotech clients)
- subject matter expertise (cGMPs, QSR, and more)
- mastery of the classroom and students
#FDA #cGMP #QSR #GMP #training #courses #classes #live #onsite
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Thursday, October 15, 2015
Plan Now - Choose SkillsPlus Intl Inc. cGMP Training
Updated February 27, 2026:
- Call/email us, or visit our SkillsPlus Intl Inc. website
SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Friday, October 2, 2015
Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections - FDA Law Blog
"Such specialized investigators may be more adept and knowledgeable at identifying issues, making for undoubtedly “smoother inspections” instead of flailing around. But just because an inspection may be smoother, it does not mean that there will be happier consequences for the affected facilities."
'via Blog this'
#FDA #cGMP #GMP #training #courses #classes
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
Thursday, October 1, 2015
GMP Training | Live - Onsite - In-Person by ...
 |
| Allan Dewes - SkillsPlus Intl Inc. |
The entire world is having to adjust to COVID-19.
If you're finding it difficult to arrange live training, then you'll be interested in online FDA cGMP QSR GMP training courses taught by us, SkillsPlus International Inc;
- - - original post follows below - - -
cGMP Training | Live - Onsite - In-Person by Allan Dewes, SkillsPlus International Inc.
Explore SkillsPlus Intl Inc. onsite courses that master trainer, Allan Dewes, can teach in-plant, at your site. We always tailor our courses to suit your site's learning needs and environment.
SkillsPlus GMP training is engaging, energetic, and enlightening.
Here's a small sample of what our students have to say ...
Learn more: SkillsPlus Intl Inc. - FDA QSR GMP Training On-Site Course Catalog (PDF)
#FDA #cGMP #GMP #training #courses #classes
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
FDA will destroy banned imported drugs - Modern Healthcare
Updated June 16, 2025
The original link broke.
You can still read about this same topic on this FDA webpage:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports
--- the original post follows below ---
"Federal regulators will begin destroying some medications that can't be imported into the U.S. because of quality concerns.
Beginning Oct. 15, the U.S. Food and Drug Administration will destroy a drug that wasn't allowed into the U.S. because it's been found to have been “adulterated, misbranded or unapproved” and in violation of the Food, Drug and Cosmetic Act. The policy covers a drug if the value of a single dose is $2,500 or less. "
'via Blog this'
Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around
Subscribe to:
Posts (Atom)