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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Thursday, October 15, 2015

Plan Now For 2016 - Choose SkillsPlus Intl Inc QSR & GMP Training

2016 is coming - Choose SkillsPlus International Inc. cGMP training & QSR training now!

Book early to reserve your preferred dates.

Select our most popular courses (always customized for you):
  • GMP/QSR Essentials
  • Root Cause Analysis for Better Investigations
  • Writing Deviation Investigation Reports
  • Advanced Deviation Investigation Facilitation
  • Deviation Investigation: One-on-One Coaching
  • Understanding Human Errors
  • Qualstar: A GMP/QSR Simulation
Take the next step:


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Friday, October 2, 2015

Thursday, October 1, 2015

GMP Training | Live - Onsite - In-Person by ...

Allan Dewes - President of SkillsPlus International Inc.
Allan Dewes - SkillsPlus Intl Inc.
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. - 2015 On-Site Course Catalog (PDF)

#FDA #cGMP #GMP #training #courses #classes

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FDA will destroy banned imported drugs - Modern Healthcare

Read the full article: FDA will destroy banned imported drugs - Modern Healthcare Modern Healthcare business news, research, data and events:

"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. "

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Thursday, September 24, 2015

WHO Training Guide To GMPs - FREE

This is a wonderful free resource for those involved in or responsible for delivering GMP training or classroom sessions. The World Health Organization (WHO) published this guide, so that it could "help both trainers and supervisors solve some of the problems they face involving training, such as how to make the training interesting to adult learners or how to effectively use a variety of instructional methods."

A WHO Guide To Good Manufacturing Practice (GMP) Requirements, Part 3: Training (PDF), is organized by the following major chapters:
  1. Introduction and purpose of this guide
  2. The importance of training
  3. Types of training and content areas
  4. Developing and implementing training
  5. Assessment and evaluation
  6. Administrating a training programme
  7. Questionnaire
#FDA #cGMP #GMP #training #WHO

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Friday, September 18, 2015

The Fake Drug Industry Is Exploding, and We Can’t Do Anything About It - Newsweek

Read this enlightening article: The Fake Drug Industry Is Exploding, and We Can’t Do Anything About It - Newsweek:

. . ."many experts believe that the problem is on the rise and that more criminals are turning to pharmaceuticals for a simple reason: low risk and high reward. “The penalties are relatively weak for trading in falsified pharmaceuticals compared to those for trade in narcotics and human trafficking,” says Paul Newton, a professor of tropical medicine at the University of Oxford medical school who has spent decades tracking poor-quality medicines. And criminals can make a lot of money by falsifying drugs that are in high demand, in short supply or are exorbitantly expensive for consumers."

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Thursday, September 17, 2015

Robert Califf Could Transform The FDA -- The Right Way - Forbes

Read the full article: Robert Califf Could Transform The FDA -- The Right Way - Forbes:

"People who care about making sure that medicines and medical devices are safe and effective should be cheering the nomination of Robert Califf to be the new commissioner of the Food and Drug Administration, and any senators who slow his path to the job he deserves should be accused of practicing the basest kind of partisanship."

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Wednesday, September 16, 2015

Obama to Nominate Robert Califf to Lead FDA - WSJ

Read the full article: Obama to Nominate Robert Califf to Lead FDA - WSJ:

"President Barack Obama plans to nominate the prominent cardiologist and medical researcher Robert Califf as the next commissioner of the Food and Drug Administration, the White House said Tuesday.

Dr. Califf had been named the FDA’s deputy commissioner for medical products and tobacco—effectively the No. 2 post—in February. He joined the FDA from Duke University, where he had served as a professor of medicine, a leading pharmaceutical researcher and the vice chancellor for clinical and translational research."

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Monday, August 3, 2015

Request for Quality Metrics - FDA Guidance for Industry

The FDA has released a guidance document that includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to collect data and use quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.

Read the guidance:  FDA Request for QualityMetrics - Guidance for Industry (PDF)

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Thursday, July 9, 2015

FDA Amends Drug Shortage Regulations

Read the full text final rule: Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States."

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Monday, June 29, 2015

Who Offers GMP Training?

Who Offers GMP Training?

SkillsPlus International Inc. offers highly respected cGMP training. Here's why you need to choose SkillsPlus Intl Inc.:

Expertise - We've been delighting clients for more than 20 years. Allan Dewes, President & master trainer, combines his regulatory knowledge and operations experience to meet your needs. He's personable, an active listener, and a trusted partner to 100s of satisfied domestic & international clients. He helps clients succeed.

Live GMP Training - Leadership and course participants rave about our onsite courses. These popular courses are considered interactive, engaging, relevant, and sometimes fun! Students want to be in our classes, instead of trying to find ways to avoid going to class.

SkillsPlus Intl Inc. can be your one-stop shop that: meets your needs, wows students, and makes your training delivery easier!

Visit SkillsPlus Intl Inc. training products & services, or call Allan Dewes, President & master trainer, (415) 948-5220.

#FDA #GMP #training #cGMP #courses #classes

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Thursday, June 25, 2015

Wednesday, June 24, 2015

New FDA Guidance to Avoid Overfill of Vials - ECA GMP News

Read the full article: GMP News: New FDA Guidance to Avoid Overfill of Vials - ECA:

"If a liquid is withdrawn from a vial by means of a syringe, remains of the liquid stay in the vial or on its walls. Since it is nearly impossible to extract 100 % of the liquid but the dosage has to be correct, nevertheless, vials usually are slightly overfilled. A vial with a dosage of 1 ml might for example contain 1.1 ml. The FDA has two points of concern: on the one hand some manufacturers fill up to much or not enough drug products without sufficiently justifying this which may result in medication errors. On the other hand the leftover of several vials with excess volume could be pooled to obtain a further dose which could lead to microbial problems."

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View the guidance:
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products - FDA Guidance for Industry (PDF)

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Friday, May 8, 2015

Root Cause Analysis for Better Deviation Investigations - cGMP Training

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

     -- Respected -- Popular -- Effective --

Companies often get a 483 for a deviation investigation process deficiency. Here's why training is needed:
  • Teams can't solve problems, get results, or comply with FDA expectations for thorough deviation investigations. 
In this workshop, employees learn the most effective tools to find the problem's real root cause. They'll use real plant deviations to practice the tools.

To learn more:

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Friday, April 17, 2015

About the FDA's Office of Pharmaceutical Quality (OPQ) - FDA.gov

Read the full article: About the Center for Drug Evaluation and Research > Office of Pharmaceutical Quality - FDA.gov:

"What OPQ Does

OPQ is a new office within CDER that creates a single unit dedicated to product quality. The new structure, to be stood-up in January 2015, is expected to provide better alignment among all drug quality functions at CDER, including review, inspection, and research.

OPQ will combine non-enforcement-related drug quality work into one super-office, creating one quality voice and improving our oversight of quality throughout the lifecycle of a drug product. OPQ creates a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas – new drugs, generic drugs, and over-the-counter drugs."

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Read more about the OPQ:

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Wednesday, April 8, 2015

Calling all QA/QC whizzes: US FDA 'super' office hunts quality leader - in-Pharma Technologist

Read the full article: Calling all QA/QC whizzes: US FDA 'super' office hunts quality leader - in-Pharma Technologist:

"Last week Janet Woodcock – Director of the Center for Drug Evaluation and Research (CDER) – sent a memo announcing the agency had begun recruiting for the permanent Director of the new “super office,” calling for those looking to lead the CDER in matters related to the regulation of pharmaceutical quality to apply before April 14."

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Tuesday, April 7, 2015

Advanced GMP Training - The Qualstar Pharma Simulation

QUALSTAR - PHARMACEUTICAL SIMULATION (GMP TRAINING)

This cGMP training course excites, energizes, & engages students! --- Topics cover documentation, following procedures, change control, deviations, & more.

Do you have problems with documentation, following procedures, change control or deviations?

If you said, "Yes," then read on ...  Employees work in small teams in this unforgettable 3-4-hour industry simulation. The importance of documentation, procedures, change controls and deviations are stressed through competition, citations, fines, injunctions, and in some cases, even jail terms. A very short lecture component is customized to address your site’s specific compliance needs.

Learn more:  QUALSTAR - PHARMACEUTICAL SIMULATION (GMP TRAINING)

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Sunday, March 8, 2015

SEC Enforcement Director Discusses Issues for Pharmaceutical and Medical Technology Companies | The National Law Review

Read the full article: SEC Enforcement Director Discusses Issues for Pharmaceutical and Medical Technology Companies | The National Law Review:

"In a wide-ranging speech on Tuesday, Securities and Exchange Commission Director of Enforcement Andrew Ceresney discussed recent SEC actions and current concerns involving the pharmaceutical and medical technology industries. Ceresney’s speech is noteworthy because it highlights areas that are getting particular attention from the SEC’s Enforcement Division, namely the Foreign Corrupt Practices Act, internal controls and accounting, and disclosure of dealings with the Food and Drug Administration."

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Saturday, March 7, 2015

Advanced GMP Training For Leaders - The Executive Session

"Executive Session" is an advanced cGMP training course that addresses CGMP & QSR issues directly relevant to the executive leadership and management teams of manufacturers.

It can be hard to get busy executives into GMP training, even with the FDA citing companies for their executive team’s lack of CGMP training.
  • This course is designed to meet their busy schedule. 
  • Lasting 1-4 hours, this onsite class reviews current citation trends and compliance issues important to the busy executive. 
  • This course is completely customized for your company. 
Call Allan Dewes (SkillsPlus Intl Inc. 415-948-5220) to discuss your executive training needs.
Learn more about Executive Session - Advanced GMP Training For Leaders

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Monday, March 2, 2015

FDA Orange Book - 2015 (35th Edition) - New!

FDA Orange Book

Recently posted on FDA.gov:
The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations - 35th Edition (2015) - PDF

According to this "Orange Book" (aka "the List"):

"The products in this list have been approved under section 505 of the
Federal Food, Drug, and Cosmetic Act. This volume is current through
December 31, 2014.

The publication, Approved Drug Products with Therapeutic Equivalence
Evaluations (the List, commonly known as the Orange Book), identifies drug
products approved on the basis of safety and effectiveness by the Food and
Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the
Act). Drugs on the market approved only on the basis of safety (covered by
the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal®
Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital
Tablets]) are not included in this publication. The main criterion for the
inclusion of any product is that the product is the subject of an application
with an effective approval that has not been withdrawn for safety or efficacy
reasons. Inclusion of products on the List is independent of any current
regulatory action through administrative or judicial means against a drug
product. In addition, the List contains therapeutic equivalence evaluations
for approved multisource prescription drug products. These evaluations have
been prepared to serve as public information and advice to state health
agencies, prescribers, and pharmacists to promote public education in the
area of drug product selection and to foster containment of health care
costs. Therapeutic equivalence evaluations in this publication are not
official FDA actions affecting the legal status of products under the Act. "

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Saturday, February 21, 2015

The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech | RAPS

Explore the entire list of links: The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech | RAPS:

"Regulatory Focus has assembled this list of the most important FDA webpages, government websites and non-governmental websites, all in the hopes of making FDA-related information easier to find.

This page is intended to assist anyone interested in FDA, including regulatory professionals, journalists, academics, patients, healthcare providers and stock traders."

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