Robert Califf, F.D.A. Nominee, Queried on Industry Ties - The New York Times

• Trusted FDA CGMP online training courses sold by SkillsPlus International Inc.

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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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:

• Learn more about cGMP training courses taught by SkillsPlus International Inc.

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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.

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

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

• FDA GMP Online Training - trusted CGMP training courses offered by SkillsPlus International Inc.

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

The new year 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:

• Call/email us, or visit our SkillsPlus Intl Inc. website

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Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections - FDA Law Blog

Read the entire article: FDA Law Blog: Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections:

"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."

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

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

Allan Dewes - SkillsPlus Intl Inc.

Updated July 16, 2020

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;

• FDA GMP QSR cGMP Online Training Courses - presented by 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

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FDA will destroy banned imported drugs - Modern Healthcare

• Trusted FDA CGMP online training courses sold by SkillsPlus International Inc.

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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WHO Training Guide To GMPs - FREE

• People also search for Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses - GMP online training classes offered by SkillsPlus International Inc.

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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The Government Really Means It This Time - FDA Law Blog

• Trusted FDA GMP online training programs and classes offered by SkillsPlus International Inc.

Read the full article: FDA Law Blog: The Government Really Means It This Time:

"In the last year alone, several high-level government officials have repeated the clear message that responsible corporate officers are in the crosshairs of DOJ and FDA in both misdemeanor and felony situations."

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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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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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Obama to Nominate Robert Califf to Lead FDA - WSJ

• FDA GMP QSR cGMP Training - highly recommended online training courses by SkillsPlus International Inc.

Updated December 3, 2020

You might also be interested in:

As Nation Awaits Vaccine, Biden Is Under Pressure to Name New FDA Chief ASAP - KHN

- - -  original blog post follows below  - - -

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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In a first, drug using 3D printing technology gets FDA nod | Reuters

Read the full article: In a first, drug using 3D printing technology gets FDA nod | Reuters:

"The U.S. Food and Drug Administration has, for the first time, approved a drug that uses 3D printing technology, paving the way for potential customization of drugs to suit patients' needs.

The drug, made by privately held Aprecia Pharmaceuticals Co, was approved for oral use as a prescription adjunctive therapy in the treatment of epilepsy, the company said on Monday."

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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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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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WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group

• Respected FDA cGMP online training programs and courses taught by SkillsPlus International Inc.

View the article with multiple links:  GMP News: WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group, an ECA Foundation Interest Group:

"For those working in the area of Good Distribution Practice (GDP) the following paper might be interesting: Technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products."

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Who Offers GMP Training?

Updated March 10, 2021

Given the COVID-19 pandemic, people also search for:

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

---  original post follows below  ---

Who Offers GMP Training?

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

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 (415) 948-5220.

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

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FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing

• FDA cGMP online training programs and courses offered by SkillsPlus International Inc.

Read the full article: FDA slaps U.S. drugmaker over drug testing issues - FiercePharma Manufacturing:

"Inspectors were particularly troubled with batch testing after inspectors found "multiple incidents of inaccurate batch production records containing erroneous statements, including results that were not derived from analytical testing" or from certificates of analysis (CoAs) of its suppliers."

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You might also be interested in the following GMP training course:

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

• FDA cGMP QSR GMP Training - online training courses by SkillsPlus International Inc.

Updated July 2, 2024;

The original link broke.

People are also asking about:

Moderna asks FDA's permission to add 5 more COVID-19 vaccine doses per vial - Becker's Hospital Review

- - -  the original post follows below  - - -

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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---------

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Ex-Homeland Security cyber chief warns of threats to outsourcing firms - Outsourcing Pharma

Read the full article: Ex-Homeland Security cyber chief warns of threats to outsourcing firms - Outsourcing Pharma:

. . . "drug companies should consider the weaknesses in all their relationships, from research contracts to materials supply, big data, logistics, cloud solutions such as SalesForce used by sales and marketing companies, and file-sharing services."

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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:

• call Allan Dewes (415-948-5220), or
• visit  http://www.skillsplusinc.com/root_cause.htm

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FDA Law Blog: Proposed Personal Care Products Safety Act Would Significantly Expand FDA Authority over Cosmetics

Read the full article: FDA Law Blog: Proposed Personal Care Products Safety Act Would Significantly Expand FDA Authority over Cosmetics:

"The almost 100-page bill would significantly expand FDA's authority over cosmetic products sold in the United States.  The bill addresses a range of issues including registration of facilities, registration of products, mandatory recall authority, adverse and serious adverse event reporting, good manufacturing practices, and user fees.  "

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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:

• FDA cGMP QSR GMP Training - online training courses by SkillsPlus Intl Inc.

"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:

• White Paper: FDA Pharmaceutical Quality Oversight (PDF - 2.4MB)

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

• People also search for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
  

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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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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Top 10 U.S. Biopharma Clusters - GEN

View the complete list: GEN | Insight & Intelligence™:Top 10 U.S. Biopharma Clusters:

"GEN ranks regions based on five criteria:  . . .

'via Blog this'

1. NIH funding
2. Venture Capital (VC) funding
3. Patents
4. Lab space
5. Jobs

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

• People also look for FDA GMP Online Training - respected FDA CGMP online training courses offered by SkillsPlus International Inc.

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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Advanced GMP Training For Leaders - The Executive Session

Updated April 22, 2024

Our Executive Session course is no longer offered.

You might also be interested in:

• FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

---  the original post follows below  ---

Executive Session - Advanced cGMP Training

"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. 

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FDA Orange Book - New!

• People also search for FDA CGMP Online Training - recommended FDA GMP online training courses offered by SkillsPlus International Inc. (a trusted compliance training provider)

FDA Orange Book

Recently posted on FDA.gov:
The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations - 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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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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Why Are Generic Drugs Getting More Expensive? - Drug Channels

• FDA CGMP Online Training - trusted GMP training courses offered by SkillsPlus International Inc.

Read the full article: Drug Channels: Why Are Generic Drugs Getting More Expensive?:

" . . .some of the factors driving price increases for generic drugs, including:

• Consolidation among generic drug companies 
• Shortage of raw materials 
• Gaps in production schedules 
• Supply and demand, and 
• Regulatory issues"

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Candidate to Lead FDA Has Close Ties to Big Pharma | TIME

• Respected FDA GMP online training courses taught by SkillsPlus Intl Inc.

Read more about Robert Califf: Candidate to Lead FDA Has Close Ties to Big Pharma | TIME:

"The agency faces potentially dramatic changes this year as Congress prepares to rewrite many of the rules for how drugs and medical devices are reviewed and tested for safety and efficacy. Califf is widely respected in the public and private sectors, but his candidacy is seen by some as a threat to the independence and authority of the FDA, thanks to his views on the need to accelerate change and his deep financial and intellectual ties to the pharmaceutical and medical device industries."

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GMP Olympics Annual Update - cGMP Training

• Buy now! FDA GMP online training courses sold by SkillsPlus International Inc.

Updated September 18, 2023

The Olympics course is no longer available.

You might also be interested in:  

The best and recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

---  the original post follows below  ---

So your team thinks they “know it all” about CGMPs? This course puts them to the test!

This cGMP Olympics course tests their knowledge of the regulations during one day of these highly interactive activities:

• Heard On the Street 
• CGMP Speed Dash 
• CGMP Challenge 
• Inspection Detection 

Everyone learns something new in class!

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The Head of the FDA is Leaving. Here’s Why That’s a Big Deal. | TIME

Read the full article: The Head of the FDA is Leaving. Here’s Why That’s a Big Deal. | TIME:

"The role of the FDA Commissioner will be central in deciding when and whether to defend the agency’s powers in the face of deregulatory reforms, not least because both parties and the White House support varying degrees of change. “The administration is very engaged,” in the changes afoot on Capitol Hill, says one Democratic Senate aide, and “Any incoming FDA commissioner is going to play a big role in the process.”"

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CGMP Training - GMP Essentials for Drug Manufacturers

Updated September 15, 2021

The original link broke.

People also need basic FDA CGMP online training courses taught by SkillsPlus International Inc.

---  the original post follows below  ---

GMP Essentials for Drug Manufacturers - An Onsite GMP Training Course

Intended for: 

• new employees and non-cGMP transfers who need basic cGMP training, or
• current staff or those individuals needing refresher training.

This highly interactive course gets everybody talking about current CGMP practices, underlying laws and regulations, the consequences of non-compliance, and recent trends. Many CGMP principles are experienced hands-on in this session. This course is usually customized to meet the needs of the organization, and can be designed to run over 1-3 days. Call (415) 948-5220, to discuss your specific needs. 

Read the feedback:

• The exercises were great! 
• The lack of excessive breaks was a great time saver.
• Lively and friendly
• The instructor's experience was very helpful. 
• Group activities helped in the learning. 
• It never dragged on. 
• Allan seems to know when to move on. 
• Teacher was great! 
• Content explained clearly 
• A nice balance of PowerPoint and activities 
• This class helped me see where we need to make changes in what we are doing. 

Learn more about this onsite cGMP training course, GMP Essentials for Drug Manufacturers - GMP training by SkillsPlus Intl Inc. 

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Pfizer to Buy Hospira for $16 Billion - WSJ

• People also search for FDA CGMP Online Training - recommended FDA GMP online training courses sold by SkillsPlus International Inc.

Read the full article:  Pfizer to Buy Hospira for $16 Billion - WSJ:

"Pfizer Inc. agreed to buy Hospira Inc., a maker of injectable drugs and infusion technologies, for about $16 billion, putting its cash to work as it deals with billions lost in sales from drugs losing patent protection.

Hospira shareholders will receive $90 a share in cash, a 39% premium to Wednesday’s close. Shares surged 37% to $88.50 premarket. The stock’s previous high, set earlier this year, was $66.56 a share."

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Obama: Let's Take Food Regulation out of FDA | RAPS

• FDA cGMP online training courses and programs offered by SkillsPlus International Inc.

Read the full article: Obama: Let's Take Food Regulation out of FDA | RAPS:

"The proposal, contained within Obama's budget proposal for fiscal year 2016, would consolidate all regulatory authority for food under a "single new agency within The Department of Health and Human Services," according to the budget.

"This new agency would be independent from FDA and have primary responsibility for food safety inspections, enforcement, applied research, and outbreak response and mitigation," the White House explains in the budget. "The new agency would be charged with pursuing a modern, science-based food safety regulatory regime drawing on best practices of both agencies, with strong enforcement and recall mechanisms, expertise in risk assessment, and enforcement and research efforts across all food types based on scientifically supportable assessments of threats to public health. The agency would also serve as the central point for coordinating with State and local entities and food safety stakeholders.""

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US FDA launches overarching Office of Pharmaceutical Quality - iPT

Read the full article: US FDA launches overarching Office of Pharmaceutical Quality - iPT:

"Within the OPQ, the agency will create an Office of Surveillance, which will be tasked with creating new quality metrics, and will let OPQ inspectors know if they need to inspect manufacturing facilities during an NDA (new drug application) review.

After a new industry range of metrics is published, she added that FDA will take “the first two years to make sure we’re measuring apples and apples” and allow facilities to see where they stack up against competitors.

The agency will undergo the “same type of work but new inspection protocols will be” standardized and help industry understand how pre-approval and surveillance inspections can be done, Woodcock said."

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GMP QSR cGMP Training Course Catalog - by SkillsPlus Intl Inc.

Updated March 10, 2021 With the COVID-19 pandemic all around us, people also search for: Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses - - -  Get ready for the coming year's cGMP QSR GMP training Are you planning your CGMP training schedule for the coming year?  Do you wish you had more instructors? Do you need more time to develop the courses? If you answered yes to any of the questions above, then take a look at our current list of classes, courses, workshops, and seminars that we can bring to your plant site.

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Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog

View the chart & read the full article:  FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog:

". . . FDA 483 Inspectional Observations for Fiscal Year 2014. 483s increased in foods from the prior fiscal year to 2476, an increase of 3.8%. However, medical devices and drugs were down -11.6% and -6.5%, respectively, from FY 2013. Interestingly, medical device 483s bucked their recent upward trend with the lowest number of observations since FY 2009."

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