Showing posts with label free. Show all posts
Showing posts with label free. Show all posts

Monday, April 18, 2022

FDA proposes to rate pharmaceutical manufacturing facilities - RAPS

According to the article:

"The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s quality management maturity (QMM)  as a way to mitigate drugs shortages and enhance the quality of finished drug products, according to a new white paper. The ratings would be publicly available."

Read the full source article: FDA proposes to rate pharmaceutical manufacturing facilities - RAPS

Go to the white paper referenced above, CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) - An Office of Pharmaceutical Quality (OPQ) White Paper - Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals 

Tuesday, September 28, 2021

Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov

According to the FDA: 

"Enjoy a safe and happy Halloween by following these guidelines.

Halloween is fast approaching, and you and your kids may be celebrating it a bit differently this year. Whatever form your celebration takes, make sure it includes safe hygiene practices such as covering your mouth and nose with a cloth face covering or mask when around others, maintaining social distance and frequent hand washing.  The Centers for Disease Control also have tips for protecting yourself and others.

Whether you’re a ghost or zombie, vampire or witch, poor costume choices—including decorative (colored) contact lenses and flammable costumes—and face paint allergies can cause injuries that haunt you long after Halloween.

Enjoy a safe and happy Halloween by following these guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention:" ...

Source Article:  Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov

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Saturday, December 26, 2020

The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm - Medtech Insight

According to the article:

"Executive Summary

From our archives: Despite the COVID-19 pandemic severely curtailing the US FDA’s ability to conduct on-site facility inspections, it’s still vitally important for manufacturers to remain audit-ready. In this collection of a 10-part Compliance Corner series, four longtime industry experts share evergreen advice on the best and worst things firms could do during an inspection."

Read the full source article:  The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm - Medtech Insight

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

 

Tuesday, February 9, 2016

Major shift ahead in how FDA regulates drug quality: PwC

Updated June 27, 2022

The link to the original source article broke.

---  the original post follows below  ---

FDA Drug Quality Report - Major shift ahead in how FDA regulates drug quality: PwC:

"Parts of the pharmaceutical industry continue to struggle with drug quality. A major shift in the way the FDA oversees drug quality could pose new challenges for companies with inadequate control over their manufacturing facilities and supply chains."

'via Blog this'

Read the PwC report:
Major shift ahead in how FDA regulates drug quality (PDF)

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Wednesday, November 11, 2015

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:
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Tuesday, October 20, 2015

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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Thursday, September 24, 2015

WHO Training Guide To GMPs - FREE

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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Thursday, June 25, 2015

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

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."

'via Blog this'

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

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Monday, March 2, 2015

FDA Orange Book - New!

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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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."

'via Blog this'

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Wednesday, May 7, 2014

What To Do 15 Minutes Before A Presentation - Business Insider

Click the link below to see the 10 things you can do . . .

What To Do 15 Minutes Before A Presentation - Business Insider:

"Whether you're stepping to the front of the room to speak to just a few people, or making a grand entrance in a ballroom to address thousands, you can effectively use the time immediately before you go up to prepare your body and mind for peak performance, Price says.

Here are 10 things you can do in the 15 minutes before a big presentation to optimize your speaking success:"

'via Blog this'

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Thursday, September 5, 2013

ICH Increases Transparency - Publishes Its New Procedures Manual


ICH Looks to Increase Transparency of its Activities, Processes with New Procedures Manual:

"The International Conference on Harmonisation (ICH), a pharmaceutical regulatory harmonization body consisting of regulators from the US, EU and Japan, is publishing new documents intended to explain in full detail exactly what goes on within its regulatory black box."

For your reference:
ICH Procedures (PDF)

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Monday, June 17, 2013

FDA - Hurricane Preparedness Free Tips


Updated April 24, 2024

You can still read about the same topic here:

---  the original link broke  ---

Be safe, be prepared. Follow the link below to the FDA's tips on hurricane preparedness.

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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Tuesday, November 13, 2012

Why GMP Training Does Seem To Work


Why GMP Training Does Seem To Work
Free Training Tips from SkillsPlus International Inc. - by Allan Dewes
Allan Dewes - President, SkillsPlus International Inc.
GMP training doesn’t always seem to make a difference. We send our employees to class, yet they never change their compliance practices. Perhaps our employees are doing what we unintentionally encourage them to do – even though it’s not what we really want. There can be several reasons for this:
  1. poorly designed or delivered training, 
  2. a disconnect between what is taught in class and what is professed on the line and in meetings, and 
  3. a lack of an organizational infrastructure to support and encourage GMP compliance 

Poorly Designed or Delivered Training 
A good design doesn’t have to look good, but it helps. A good design follows a logical flow and links concepts together in a logical flow that leads to a logical conclusion of what is the appropriate behavior. Employees need to know what the gaps are between what is currently practiced, and what is expected. However, even the best design in the world may be totally ineffective if the class is asleep. For instance, employees that have been working for eight hours before a class, are often made to sit in a dimly lit conference room, listening to the instructor drone on for the 93rd time about using black ink in documentation. GMP training delivery must be alive – kick it up! Remember, as trainers we are competing with the jazz of Nintendo, Wii, smartphones, and the Internet. Activities that reinforce learning objectives are a great way to jazz up training for even the most reserved trainers.

Disconnect Between Preaching & Practice 
A telltale sign of a disconnect between what is preached in the organization and what is practiced can be quickly assessed in the plant floor rumblings. Have you ever heard someone say, "I know what ‘they’ told me in class, but my supervisor wants me to get the product out the door." Perhaps you recently heard, "Those trainers don’t know how the job is really done around here." Or maybe you heard, "Tell management about these rules, they need to hear it." These comments are usually countered with, "Where did they ever get those ideas from? Of course I want GMP compliance!" However, somewhere in the employee’s work life they heard a message different than the one you intended. For example, the speed limit on many highways is stated as 65 mph (your area may be different). The message appears to be clear, but many drivers exceed the speed limit. So, what is the message many drivers hear – it’s okay to drive 70 mph. Is that second message intentional or not? Is it spoken or unspoken? Do we send the right messages about our compliance intentions?

Lack of Organizational GMP Compliance Support and Encouragement 
If behavior doesn’t change, so say behaviorists, then the environment hasn’t encouraged or supported the desired change. Let’s continue the analogy of the driver speeding on the highway. There are obviously little or no consequences for exceeding the speed limit by perhaps 5-7 mph. (Please note: I’m not giving drivers permission to exceed the speed limit, nor am I liable for those who do get tickets, I’m merely reporting an observation.) What would happen if we were all (100% of us) given speeding tickets for even 1 mph over the limit? Behavior would change, or some of us would go broke. So how are we doing in the area of GMP compliance in our plants? I see many QA auditors correcting batch records with little or no feedback to the person who made the mistake for the 93rd time. I see people responsible for SOP updates that can’t get comments back because, "We were too busy." I see trainers with empty classes because we had product to get out the door.

The Recipe For A Successful GMP Compliance Initiative Includes: 
  1. Strong training program design 
  2. Delivery with the energy and jazz of current entertainment media 
  3. Rich and accurate content 
  4. Consistent messages with the practices demonstrated by our behavior and decisions 
  5. Organizational systems that encourage and support GMP compliance! 
  6. Have SkillsPlus Intl Inc. deliver your next training. Call:  (415) 948-5220

About the Author 
Allan Dewes is the Executive Consultant of SkillsPlus International Inc. Allan is a master trainer, possessing over 30 years experience in identifying training needs and designing QSR & cGMP training programs. He is known for designing user friendly courses and conducting highly interactive classes that teach concepts easily and playfully.

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Monday, March 12, 2012

Using Video In The Classroom - Free GMP and QSR Training Tip

Scan of a DVD 4.5 capacity disk
Image via Wikipedia
Using videos and DVDs in the classroom isn't difficult. And they're not intended to be a babysitter while the instructor gets a cup of coffee. Successfully using videos and DVDs in the classroom requires four simple steps, three of which are often forgotten, and a qualified instructor.
  1. Tell the class what they are going to see and why you want them to see it. 
  2. Give the class an assignment to perform during and immediately after the video or DVD has ended. The assignment can be as simple as, "During this DVD write down as many things you did not know prior to watching this DVD." 
  3. Now it's time to turn on the DVD. See our list of SkillsPlus Intl Inc. movies and interactive CBTs 
  4. After the DVD is over, follow up on what the class has learned. Using the round robin technique, chart everybody's responses. As an instructor, elaborate on the class response as appropriate.
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