Saturday, September 24, 2016

Advanced cGMP Training - Root Cause Analysis & Deviation Investigation Reports

Advanced cGMP Training
Advanced GMP Training - Root Cause Analysis & Deviation Investigation Report Writing

Pinpointing the wrong cause (for example, a "false" root cause) can result in ineffective immediate, corrective, and preventive actions.
  • Throwing fixes at the wrong things might not fix the problem.
  • Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis.
By taking our advanced courses, you'll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

These highly popular advanced cGMP training classes are taught at the location of your choice. You might be interested in two of our highly inter-related courses.

Root Cause Analysis for Better Deviation Investigations: On-site Advanced GMP Training by SkillsPlus International Inc.  
     Course Objectives:
  • Use tools and techniques to effectively identify the deviation statement
  • Identify the root cause of the deviation. 
  • Generate and objectively select the best corrective and preventive actions.
  • Assess the risk of implementing the corrective action and preventive action.
  • Develop a contingency plan to preventive action implementation.
  • Create corrective actions and preventive action metrics. 
Deviation Investigation Reports: On-Site Advanced GMP Training by SkillsPlus International Inc.
      Course Objectives:
  • Increase investigation report suitability for FDA review. 
  • Decrease the number of reports returned by internal reviewers. 
  • Write supported deviation statements. 
  • Provide a detailed background statement to include related information, investigations, affected materials and references. 
  • Document deviation investigation findings. 
  • State the root cause with supporting facts. 
  • Generate supported, plausible, and defensible corrective actions. 
  • Develop effectiveness measures for the corrective actions. 
  • Generate realistic preventive actions. 
  • Develop effectiveness measures for the preventive actions. 
  • Develop a follow up plan for corrective and preventive actions. 
  • Write accurate executive summary statements. 
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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Tuesday, September 20, 2016

Advanced cGMP Training Courses & Classes

Advanced GMP Training

Advanced GMP Training Workshops & Seminars

SkillsPlus International Inc. offers both advanced and basic GMP training courses and classes. While serving over 350 clients and customers world-wide (in the pharmaceutical, biotech, and medical device industries), it is our mission to provide quality training and consulting services that meet the needs of the client organization.

Do you have an advanced cGMP training need?  Then give us a call to see how we can help you:  (415) 948-5220.

Learn more about SkillsPlus Intl Inc.'s principal course instructors


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

#FDA #cGMP #GMP #training #basic #advanced #courses #classes #workshops #seminars

Sunday, July 24, 2016

GMP Basics for Beginners & Experienced Team Members - cGMP Training Course

cGMP Basics Training Course for Beginners, and Experienced Professionals

Naturally you'll want your new hires introduced to the basics of the FDA cGMP regulations.

Don't forget that your experienced team members need occasional doses of GMP refresher training too!

You might be interested in our cGMP training course:
"Essentials for Pharmaceutical Manufacturers."
GMP training for beginners and experienced team members


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cGMP training for beginners and experienced professionals


SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Thursday, July 21, 2016

8th Circuit Issues Decision Significant For All Executives Of FDA-Regulated Businesses - Consumer Protection - U.S. - mondaq.com

Read the full article: Eighth Circuit Issues Decision Significant For All Executives Of FDA-Regulated Businesses - Consumer Protection - United States - mondaq.com:

"Judges Murphy and Gruender explained, RCO liability bears on the blameworthiness of a corporate officer who failed to prevent or remedy the condition at issue. And any executive operating in the highly regulated world of food and drugs, where widespread harm can be the outcome of corporate negligence, has a “heightened degree of foresight and care.”"

'via Blog this'

RCO = responsible corporate officer

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Tuesday, July 12, 2016

FDA to Drug Compounders: Inspection Changes Coming in August | RAPS

Read the full article: FDA to Drug Compounders: Inspection Changes Coming in August | RAPS:

"For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators will make a preliminary assessment of whether such entities are compounding their human drugs in accordance with certain conditions of section 503A before closing the inspection.”"

'via Blog this'


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Friday, April 22, 2016

Priorities – Teamwork to Achieve Common Goals | FDA Voice

Read Dr. Califf's Priorities – Teamwork to Achieve Common Goals | FDA Voice:

"With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work for the nation and its citizens. During my vetting process I received hundreds of emails and had almost as many conversations with a large and diverse group of stakeholders. Over the course of these discussions, a recurring theme emerged: namely, that setting priorities would be critical to success."

'via Blog this'


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Wednesday, March 23, 2016

FDA Approved 3D Printed Drug Available In The US - Forbes

Read the full article: FDA Approved 3D Printed Drug Available In The US - Forbes:

"To create the 3D printed Spritam, all the elements are assembled layer-by-layer without compression or traditional molding techniques. Thin layers of powdered medication are then repeatedly spread on top of one another, as patterns of liquid droplets are printed onto selected regions of each powder layer. Interactions between the powder and liquid bond the materials together at a microscopic level."

'via Blog this'


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Wednesday, February 24, 2016

Wednesday: FDA commissioner | TheHill

Read the full post:  Wednesday: FDA commissioner | TheHill:

"The Senate will take a final vote Wednesday on President Obama's nominee to lead the Food and Drug Administration.

The vote on Robert Califf's nomination to be the next FDA commissioner comes after senators overwhelmingly agreed to end debate on the nomination Monday in a 80-6 procedural vote. "

'via Blog this'


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Monday, February 22, 2016

Robert Califf Senate vote could clear path to top FDA job - STAT News

Read the full article: Robert Califf Senate vote could clear path to top FDA job - STAT News:

"In a move designed to circumvent opposition to Califf, who was nominated in September, Senate Majority Leader Mitch McConnell has scheduled a procedural vote for Monday afternoon. If Califf wins the support of at least 60 senators in that vote, he would move on to a final confirmation vote — likely Tuesday — and his Senate opponents would lose their leverage to stop him."

'via Blog this'


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!