Tuesday, November 15, 2016

Root Cause Analysis - cGMP Free Tip

GMP Free Tip on Root Cause Analysis (RCA)

The FDA says, "Human error is not a root cause." If your first reflex is blaming human error, it's time to re-think the situation in order to identify the real root cause of the human error.

There are several categories of human errors: slips, lapses, and induced errors. These can account for a large percentage of errors. In order to understand these human errors in more detail, they can be investigated through the use of investigative tools such as a Walk Through Analysis or Control Barrier Analysis.

Once the underlying contributing factors and real root cause(s) are understood, then they can be controlled (in many cases).

Learn more about this topic by taking these courses by SkillsPlus Intl Inc:
Root Cause Analysis for Better Investigations - A cGMP QSR GMP Training Course
Deviation Investigation Report Writing - A GMP QSR cGMP Training Workshop


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FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
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Thursday, October 20, 2016

Emerging Issues and Cross-Cutting Scientific Advances - FDA; Establishment of a Public Docket - Federal Register

Go to the full notice: Federal Register :: Emerging Issues and Cross-Cutting Scientific Advances; Establishment of a Public Docket - FDA:

"The Food and Drug Administration (FDA) is establishing a public docket to receive input on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-Agency activities. Interested parties are invited to submit comments regarding emerging technologies and cross-cutting scientific advances of importance to FDA. The focus is on areas that may impact FDA in 5 or more years."

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

 

Tuesday, October 18, 2016

FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews

Read the full article: FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews:

"The guidance seeks to articulate what's new and different about SaMD (a category which would include mobile medical apps) and provide a stratified guidance on how to regulate different kinds of software and what kind of evidence is needed for each regulatory category. The guidance stratifies devices on two axes: whether the device informs care, drives care, or treats/diagnoses and whether the condition in question is non-serious, serious, or critical. So software that treats or diagnoses a critical condition is in the highest risk category, while software that informs care about a non-serious condition is in the lowest."

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View the draft guidance:
Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability

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

 

Monday, October 3, 2016

Paula Marks Joins The SkillsPlus International Inc. Training Team

Paula Marks, M.S. - SkillsPlus International Inc. Certified Trainer
Paula Marks - SkillsPlus Intl Inc. Certified Trainer
SkillsPlus Intl Inc. - Paula Marks joins the training staff at SkillsPlus International Inc.

SkillsPlus International Inc. is excited to add Paula Marks, M.S. to our training staff. Ms. Marks has practical and management experiences in various pharmaceutical, biotechnology, cell-therapy, research and development, and medical device/IVD companies. A SkillsPlus Intl Inc. certified trainer since 2007, Ms. Marks brings a personal rapport and commitment to her cGMP and deviation investigation training sessions.

Please join us in welcoming Paula to our team.

Learn more:  About Us - SkillsPlus International Inc.

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

 

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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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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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.”"

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RCO = responsible corporate officer

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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.”"

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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."

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Root Cause Analysis - GMP Training
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