Tuesday, April 7, 2015

World Health Day 2015: A Global Focus on Food Safety | FDA Voice

Read the full post:  World Health Day 2015: A Global Focus on Food Safety | FDA Voice:

"Food safety is a public health issue that affects all nations – from the most advanced to the most poor. World Health Day, observed on April 7 each year to mark the anniversary of the 1948 founding of the World Health Organization (WHO), gives us an opportunity to reflect on the progress that has been made to address the need for strong food safety systems, and on the enormous challenges that lie ahead.

The global importance of this issue is reflected in this year’s World Health Day theme: “Food Safety: From Farm to Plate, Keep it Safe.”  Keeping food safe, from farm to table, is at the core of our mission as an agency and at the heart of the preventive, risk-focused food safety system envisioned by the FDA Food Safety Modernization Act (FSMA)."

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Monday, April 6, 2015

Qualstar Simulation - An Advanced CGMP Training Course

Qualstar: A Pharmaceutical Simulation (cGMP Training)

Having problems with documentation, following procedures, change control or deviations?

In this GMP training course, employees work in small teams in this unforgettable 3-4-hour industry simulation. The importance of documentation, procedures, change controls & 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.

This cGMP training course excites, energizes, & engages students! Training content covers documentation, following procedures, change control, deviations, & more.

Learn more about this course: http://www.skillsplusinc.com/qualstar.htm

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Saturday, March 14, 2015

FDA Clarifies Its Role on “Palcohol” - FDA.gov

Read the full post:  - FDA.gov:

Food Additives & Ingredients > FDA Clarifies Its Role on “Palcohol”

"March 13, 2015

The FDA is aware of inaccurate reports that the FDA has approved this product. To clarify, our evaluation focused solely on the non-alcohol ingredients added to the alcohol beverage versions of this product. We did not provide an approval, nor did we conduct any testing."

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Friday, March 13, 2015

Advanced cGMP Training For Leaders & Top Management

Advanced GMP Training For Leaders - Our "Executive Session" course is designed for executives & management teams.

It's 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 for leaders with busy schedules. 
  • Lasting 1-4 hours, this onsite class reviews current citation trends & compliance issues that are important to executive and management teams. 
  • This course is completely customized for your company. 
Call Allan Dewes (415-948-5220) to discuss your training needs.
Learn more about Executive Session - Advanced GMP Training

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Wednesday, March 4, 2015

GMP Olympics - cGMP Training

GMP OLYMPICS - GMP 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, and 
  • 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, or learn more: Olympics for CGMP - GMP Training by SkillsPlus Intl Inc.

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Friday, February 20, 2015

Ingredient in Olive Oil Looks Promising in the Fight Against Cancer | Rutgers

Read the full article: Ingredient in Olive Oil Looks Promising in the Fight Against Cancer | Media Relations - News.Rutgers.Edu:

"Paul Breslin, professor of nutritional sciences in the School of Environmental and Biological Sciences, and David Foster and Onica LeGendre of Hunter College, report that oleocanthal kills cancerous cells in the laboratory by rupturing vesicles that store the cell’s waste. LeGendre, the first author, Foster, the senior author, and Breslin have published their findings in Molecular and Cellular Oncology."

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Thursday, February 19, 2015

FDA Safety Communications > Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

Read the entire communication: Safety Communications > Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication - FDA.gov:

"The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it."

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Wednesday, February 18, 2015

Scientists Find a Way to Block HIV from Infecting Healthy Cells | TIME

Read the full article: Scientists Find a Way to Block HIV from Infecting Healthy Cells | TIME:

"Michael Farzan, professor of infectious diseases at Scripps Research Institute, and his team used a gene therapy technique to introduce a specific HIV disruptor that acted like gum on HIV’s keys. Once stuck on the virus’s surface, the peptide complex prevents HIV from slipping into the molecular locks on healthy cells. "

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Friday, February 13, 2015

Does a Real Anti-Aging Pill Already Exist? - Bloomberg Business

Structural diagram of (rapamycin). Created usi...
Structural diagram of (rapamycin). Created using ACD/ChemSketch 10.0 and . (Photo credit: Wikipedia)
Read the full article: Does a Real Anti-Aging Pill Already Exist? - Bloomberg Business (re: rapamycin & its derivatives):

"An innovative clinical trial set to begin in March may resolve some of these issues. Kaeberlein and his University of Washington colleague Daniel Promislow plan to test the drug in small doses in middle-aged pet dogs. Rather than looking at life span, which would take years, they will look for signs that the drug is affecting key aging-related parameters, such as arterial stiffness and cardiac function. If successful, rapamycin and its derivatives could end up as the first anti-aging drug—for dogs. Kaeberlein wouldn’t mind: “I love my dogs,” he says. “If there’s anything we can do to make them live longer, healthier lives, we have to do it. I feel like I personally have to do this.”"

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Monday, February 9, 2015

Drug Making Breaks Away From Its Old Ways - WSJ

Read the full article: Drug Making Breaks Away From Its Old Ways - WSJ:

"Under the new approach, raw materials are fed into a single, continuously running process. Many other industries adopted such a “continuous-manufacturing” approach years ago, because quality can be checked without interrupting production—with weeks shaved off production times and operating expenses cut by as much as 50%.

Until recently, pharmaceutical companies have been stuck making drugs the old-fashioned way, mixing ingredients in large vats and in separate steps, often at separate plants and with no way to check for quality until after each step is finished. Any desire to modernize was partly blunted, industry officials say, by the high margins netted on the industry’s string of billion-dollar-selling drugs."

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Friday, February 6, 2015

National Sleep Foundation changes recommended snooze time - USA Today

Read the full article & view sleep duration recommendations by age group:
National Sleep Foundation changes recommended snooze time - USA Today:

"The National Sleep Foundation has revamped its recommendations for the way we recharge.

The non-profit scientific foundation, along with a panel of experts, updated its nightly sleep duration advice for all ages in a report published Feb. 2 in Sleep Health: The Official Journal of the National Sleep Foundation."

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Thursday, February 5, 2015

FDA commissioner steps down in March | Pharmafile

Read the full article: FDA commissioner steps down in March | Pharmafile:

"The commissioner of the US Food and Drug Administration Dr Margaret Hamburg is to resign from her post in March according to unconfirmed reports.

Hamburg who has been leading the agency for almost six years, is set to be temporarily replaced by the US regulator’s chief scientist Stephen Ostroff until a permanent replacement is found, all of which is set to be officially announced tomorrow by the White House."

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Massive breach at health care company Anthem Inc. - USA Today

Read the full article: Massive breach at health care company Anthem Inc. - USA Today:

"The hackers gained access to Anthem's computer system and got information including names, birthdays, medical IDs, Social Security numbers, street addresses, e-mail addresses and employment information, including income data, Swedish said.

The affected database had records for approximately 80 million people in it, "but we are still investigating to determine how many were impacted. At this point we believe it was tens of millions," said Cindy Wakefield, an Anthem spokeswoman.

That would make it "the largest health care breach to date," said Vitor De Souza, a spokesman for Mandiant, the computer security company Anthem has hired to evaluate its systems."

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Wednesday, February 4, 2015

What Timeless Advice Would You Give to a Regulatory Rookie? | FDAZILLA BLOG

Read the article, including the advice:  What Timeless Advice Would You Give to a Regulatory Rookie? | FDAZILLA BLOG:

"Sometimes we get emails from people who are just starting out in the field of regulatory, quality, and compliance, asking us – what advice do we have for new people to get onto the right path?"

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FDA finds herbal supplements at GNC, Walmart, Walgreens, and Target contain asparagus, houseplants, and no herbs | Inhabitat - Sustainable Design Innovation, Eco Architecture, Green Building

Read the full article: FDA finds herbal supplements at GNC, Walmart, Walgreens, and Target contain asparagus, houseplants, and no herbs | Inhabitat - Sustainable Design Innovation, Eco Architecture, Green Building:

"The New York State Attorney General’s Office is demanding that GNC, Walmart, Walgreens, and Target remove store brand herbal supplements from their shelves after the pills were found to be packed with a strange array of fraudulent—and in some cases hazardous—ingredients. Popular supplements such as ginseng, valerian root, and St. John’s wort sold under store brand names at the four major retailers were found to contain powdered rice, asparagus, and even houseplants, while being completely void of any of the ingredients on the label."

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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