Showing posts with label basics. Show all posts
Showing posts with label basics. Show all posts

Friday, July 22, 2016

Basic GMP Training - A course focusing on cGMP basics

Updated May 13, 2025:

Clients are now requesting online training courses:


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This live onsite course teaches the FDA cGMP basics, "Essentials for Pharmaceutical Manufacturers."

Designed for new employees and refresher GMP training for your seasoned staff.

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

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Monday, February 2, 2015

GMP Essentials for Drug Manufacturers - Onsite cGMP Training

Updated July 16, 2021

FDA GMP QSR Online Training Courses by SkillsPlus Intl Inc.

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GMP Essentials for Drug Manufacturers - An Onsite GMP Training Course
This course is appropriate for new employees, or to meet the needs of current staff and refresher training. This highly interactive course gets everybody involved talking about current CGMP practices and the consequences of non-compliance. Many CGMP principles are experienced hands-on in this course. Usually customized to meet the needs of the organization, this session can last from one to three days. Call Allan Dewes at SkillsPlus International Inc., (415) 948-5220, to discuss your specific needs and the instructor's recommendations.

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Wednesday, November 13, 2013

GMP Training Suggestions for 2014 - cGMP Essentials Course

 
 
483 Observation Gotchas!
 
1. There is no documented training in CGMPs.
2. CGMP training has not been conducted for over three years.
3. Firm lacks qualified CGMP trainers. 
 
 
Planning for Training 2014!

 2014 is just around the corner! 
  1. Do you need to get CGMP and related training completed and do not have the staff, or
  2. Are you and your staff already overloaded, or
  3. Do you just need a new and exciting approach to CGMP training?

    If you answered "Yes" to one or more of these questions, then take a look at our CGMP Essentials course.
 

Featured Course
CGMP Essentials: This course can be structured with more than two dozen different training activities designed to reinforce learning and keep employees engaged. Prior students have high praise. One manager said, "I never knew CGMP training could be so much fun." One former FDA Inspector reported, "I actually learned something."
 
Topics addressed in this very popular course:
1. Heard on the Street
2. Review of 21 CFR 211 Subparts
3. Essential Quality System Tools
4. Consequences for non-compliance, and more!
 
If your firm needs a fresh new look at CGMP training, then you need to look into our CGMP Essentials course!
 

 
Allan Dewes
Allan Dewes, President.
 
About Your Instructor
Allan Dewes
 
Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention.
 
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The Exemptee Institute
The Designated Representative Institute

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Tuesday, June 5, 2012

What is GMP for Dietary Supplements - Free Video

Updated August 12, 2021

The original video is no longer available.

You can still learn about the same topic in this video:


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This is a nice free video introduction to the FDA GMP regulations for dietary supplements.

Video no longer available.

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SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
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Wednesday, March 24, 2010

FDA Webinar on FDA Inspection Process


When:     Thursday, March 25, 2010, at 2 p.m. ET

Where:    https://collaboration.fda.gov/inspectionprocess/

Host:       FDA’s Office of Regulatory Affairs (ORA), 301-827-3101

             ORAContactUs@FDA.HHS.GOV

Speaker: Michael C. Rogers, deputy director, Office of Regional Operations

To ensure the safety of marketed products, FDA experts inspect domestic and foreign establishments, check shipments of imported products, and collect and test product samples for signs of contamination.

During this webinar, FDA experts will present information on

  • the organization within FDA that is charged with conducting inspections
  • the facilities FDA is responsible for inspecting
  • what an inspection involves
  • inspection follow-up and enforcement actions
  • the rigorous training that inspectors receive
The presentation will run approximately 30 minutes and will include an opportunity to ask questions.

To join the webinar:

  1. Click https://collaboration.fda.gov/inspectionprocess/ (or cut and paste it into your Internet browser)
  2. Click "Enter as a Guest," fill in your name, then click "Enter Room"
  3. Dial 1-877-685-5350 and enter participant passcode: 969082
You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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SkillsPlus Intl Inc. - GMP Compliance Training Experts
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The Health, Drug, Prescription, and GMP Supersite Gift Store 

Thursday, November 6, 2008

Caregivers - Medicare and Care Resource Website

Sometimes it's hard to take care of someone with healthcare needs. As a caregiver, you need access to information and resources. This Medicare website is chockful of great information and resources, Medicare - Caregiver Information. Here's what's on the site . . .

  1. Help with billing
  2. Navigating Medicare
  3. Overwhelmed? Get help
  4. Care options
  5. Medicare basics
  6. ... and more!

Return Home: http://drughealth.blogspot.com/ 

From SkillsPlus International Inc.