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."

'via Blog this'

#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."

'via Blog this'

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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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Friday, May 8, 2015

Rising Cyber Attacks Costing Health System $6 Billion Annually - Bloomberg Business

Read the full article: Rising Cyber Attacks Costing Health System $6 Billion Annually - Bloomberg Business:

"Criminal attacks against health-care providers have more than doubled in the past five years, with the average data breach costing a hospital $2.1 million, according to a study today from the Ponemon Institute, a security research and consulting firm. Nearly 90 percent of health-care providers were hit by breaches in the past two years, half of them criminal in nature, the report found."

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Wednesday, May 6, 2015

Not Recommended Internet Drug Sites - AWARxE

Read the full article & browse the list of sites: Not Recommended Sites - Safe Acquisition - Get Informed.® - AWARxE:

"Ordering drugs from these not recommended Web sites puts you and your family at risk.

Not Recommended Sites are those Internet drug outlets that appear to be out of compliance with state and federal laws or patient safety and pharmacy practice standards used by the National Association of Boards of Pharmacy® (NABP®). NABP has reviewed over 10,900 sites and found nearly 97% of those sites to be out of compliance."

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Root Cause Analysis for Better Deviation Investigations - GMP Training

Root Cause Analysis for Better Deviation Investigations - A cGMP Training Course

A top reason why companies receive a 483 is a deficiency in the deviation investigation process. In our experience, most employees need deviation investigation training, and here's why:
  • Staff struggle to solve problems
  • Teams often fail to get results
  • The pharma and biotech sector repeatedly demonstrate difficulty in complying with FDA expectations for thorough deviation investigations.
In this SkillsPlus International Inc. 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, the lead instructor, has taught this course all over the world with exceptional results.

Call Allan (415) 948-5220, or learn more: http://www.skillsplusinc.com/root_cause.htm

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Monday, May 4, 2015

Why Your Future Vaccination Might Not Be A Shot : NPR

Read the full article: Why Your Future Vaccination Might Not Be A Shot : Goats and Soda : NPR:

"Vaccines don't always make it into the people who need them the most. Many require a syringe and a needle to enter the bloodstream and create immunity. And that means a doctor or nurse has to do the job.

But with if a vaccine could be delivered by simply applying a patch? That's Mark Prausnitz's goal: creating a nickel-sized bandage-like device covered with 100 microscopic needles that would puncture the skin, then dissolve to get the vaccine into the body."

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Thursday, April 30, 2015

FDA seeks more data on safety of hospital hand cleaners - Yahoo News

Read the full article: FDA seeks more data on safety of hospital hand cleaners - Yahoo News:

"Federal health officials say more information is needed to establish the safety and effectiveness of common hand cleaners used in hospitals, doctors' offices and nursing homes to kill germs and prevent infections.

The Food and Drug Administration is asking manufacturers to submit additional data about medical hand washes and sanitizers, including the long-term effects of their daily use on the skin."

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From SkillsPlus International Inc.

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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