Friday, July 17, 2015

The F.D.A.’s Medical Device Problem - The New York Times

Read the full op-ed: The F.D.A.’s Medical Device Problem - The New York Times:

"The 21st Century Cures Act would subject millions of Americans to unsafe or untested medical devices. We urge the Senate, as it takes up the bill, to avoid these dangerous provisions. Unlike medical drugs, which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the F.D.A. are needed to ensure that innovative medical devices lead to better health."

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#FDA #GMP #training #cGMP

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Thursday, July 16, 2015

Your Google Searches Could Help the FDA Find Drug Side Effects - Bloomberg Business

Read the full article: Your Google Searches Could Help the FDA Find Drug Side Effects - Bloomberg Business:

"FDA spokesman Chris Kelly called the meeting an introduction and a chance "for the agency to begin a discussion on how we might collaborate with Google on identifying adverse event data, using Google’s technologies and data.”"

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Wednesday, July 15, 2015

SurgeonRatings.org website makes data on surgeon performance public - CBS News

Read the full news article: SurgeonRatings.org website makes data on surgeon performance public - CBS News:

"A non-profit group is making millions of records on surgeon performance available to the public.

The consumer advocacy group Consumers' Checkbook launched the website SurgeonRatings.org, which provides open access to detailed government records on patient outcomes after surgery. It says the site was created after a ten-year campaign to convince the government to release Medicare records to the public."

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#FDA #GMP #training #cGMP

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Friday, July 10, 2015

FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products - FDA Law Blog

Read the full article: FDA Law Blog: FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The final 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 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 products in the United States.”"

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You might also be interested in:
Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

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Thursday, July 9, 2015

FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs - Consumer Updates

Read the full update: FDA Consumer Updates > FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs:

"FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death. Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.)"

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#FDA #GMP #training #cGMP

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Thursday, July 2, 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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Tuesday, June 30, 2015

Gov. Jerry Brown signs bill to impose strict school vaccine legislation in California | abc7.com

Read the full article: Gov. Jerry Brown signs bill to impose strict school vaccine legislation in California | abc7.com:

"The governor of California has signed a contentious bill to impose one of the strictest school vaccination laws in the country.

Democratic Gov. Jerry Brown says in a statement Tuesday that science clearly shows vaccines dramatically protect children against infectious diseases."

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#FDA #GMP #training #cGMP

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Thursday, June 25, 2015

Scientists describe the gross reason why your eyes sometimes sting, turn red in swimming pools - The Washington Post

Read the full article: Scientists describe the gross reason why your eyes sometimes sting, turn red in swimming pools - The Washington Post:

"The CDC also said in its report that the chlorine smell of pools isn't actually what you think. "What you smell are actually chemicals that form when chlorine mixes with pee, poop, sweat and dirt from swimmer's bodies... These chemicals -- not chlorine -- can cause your eyes to get red and sting, make your nose run, and make you cough."

"Yuck!" the CDC concluded."

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#FDA #GMP #training #cGMP

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Wednesday, June 24, 2015

Fidgeting May Benefit Children With A.D.H.D. - The New York Times

Read the full article: Fidgeting May Benefit Children With A.D.H.D. - The New York Times:

"“I know it’s difficult to accommodate hyperactivity,” Dr. Schweitzer said, but it may really help children whose fidgeting bodies seem to contribute to calmer, more focused brains."

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Tuesday, June 23, 2015

Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ

Read the full article: Next Time an FDA Inspector Visits, Make Sure Everything is Dusted - Pharmalot - WSJ:

"Records indicated the company supposedly used an oxygen analyzer to obtain test results. But the FDA inspector displayed a Sherlock Holmesian propensity for uncovering discrepancies. The inspector spotted cobwebs running from the portable oxygen analyzer to an adjacent wall, according to the letter. In other words, the analyzer had not been used for, well, a while."

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Q7 Q&As - Quality Guidelines : ICH

Q7 Q&As - Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Follow this link to the Q7 section: Q7 Q&As - Quality Guidelines : ICH:

"Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs."

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Tuesday, June 16, 2015

The FDA takes step to remove artificial trans fats in processed foods

Read the full release:  Press Announcements > The FDA takes step to remove artificial trans fats in processed foods - FDA.gov:

"Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products. "

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Friday, June 12, 2015

Sleeping Pill Use Raises Car Crash Risk, Study Finds - NBC News

Read the full article: Sleeping Pill Use Raises Car Crash Risk, Study Finds - NBC News:

"Sleeping pills such as Ambien and Restoril may double someone's risk of a car crash — even after their effects should have worn off — and may raise the risk as much as having too much to drink, researchers reported Thursday.

A close look at medical and driving records showed that people who took any one of the three popular sleeping aids had anywhere between a 25 percent and three times higher risk of being involved in an accident while driving."

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Thursday, June 11, 2015

GMP Training Course Downloads by SkillsPlus Intl Inc.

GMP Training Downloads by SkillsPlus Intl Inc. - New!

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. 

#FDA #GMP #training #cGMP #course #class #LMS

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Wednesday, May 27, 2015

Hurricane Safety Checklist - FDA Public Health Focus

View the entire checklist: Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to:" . . .

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Even More Resources, Books, & Things (many from Amazon.com)

FDA, GMPs, QSR, GCP, GLP, GXP:
21 CFR Parts 210 and 211: Drug Industry GMP's     Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)     The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices     Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)     How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations     Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance     How to Develop and Manage Qualification Protocols for FDA Compliance         Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)     Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices     FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics     Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)     Clinical Studies Management: A Practical Guide to Success     Analytical Chemistry in a GMP Environment: A Practical Guide     Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)     Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook     Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)     Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)     Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition     Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)     Cleaning Validation: A Practical Approach     Validated Cleaning Technologies for Pharmaceutical Manufacturing     Risk-Based Compliance Handbook     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)     Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)     Bioprocess Validation: The Present and Future     Laboratory Validation: A Practitioner's Guide     Quality Assurance Workbook for Pharmaceutical Manufacturers     Risk-based Software Validation: Ten Easy Steps     ISO 13485 and FDA QSR Internal Audit Checklist     ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Training Resources:
1001 Ways to Reward Employees     Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition     50 Creative Training Openers and Energizers     Personalized M&M Candies     Oriental Trading Co - Training toys and supplies     GMP Training Gifts & Giveaways     GMP Training & Quality Posters     1 Dz Dakotaline Rabbit Snares