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.

GMP eLearning Courses - Our eLearning courses are available for purchase & download. They're value-packed video/multimedia courses that are ready to use in a variety of situations & settings. They can be purchased in a variety of LMS formats (AICC/SCORM). These eLearning courses are easy to get, use, and own. Buy now!  http://www.skillsplusinc.com/CBPresent.htm

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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Monday, June 15, 2015

GMP Training Downloads

cGMP Training Downloads

You need to buy and download your choice of 12 cGMP topics, in order to make your GMP training easy.
  1. Easy to get! Simply buy, then download your course(s). You get instant access!
  2. Easy to incorporate into your training program! Different formats can be used in a variety of training situations (some formats include quizzes/final exam, and AICC/SCORM for LMS).
  3. Easy to own! Once you buy the download, it's yours! Unlimited single location usage.
This is a great buy-to-own value, without user license fees! You'll have many choices on how to use these. For example, display them as a classroom video (from a PC or your intranet), standardize content delivery, or make these a part of your CAPA program.

Learn more:  call Allan Dewes (415-948-5220), or visit eLearning GMP Training Course Downloads by SkillsPlus International Inc. 

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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!

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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Thursday, February 19, 2015

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

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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Tuesday, February 17, 2015

GMP Olympics Annual Update - cGMP Training

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!

Call Allan Dewes (415-948-5220) to see how this course addresses your site’s specific training needs.
Learn more: Olympics for Pharmaceutical & Biotech Manufacturers - GMP Training by SkillsPlus Intl Inc.

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Friday, February 6, 2015

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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Thursday, February 5, 2015

CGMP Training - GMP Essentials for Drug Manufacturers

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 Allan Dewes, (415) 948-5220, to discuss your specific needs. 

Read feedback from some of our past students (what they say about this course):

  • 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

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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