Saturday, April 28, 2018

Root Cause Analysis - Deviation Investigation Reports - Online Self-Study Course

cGMP Training - Root Cause Analysis -
Deviation Investigation Report Writing

Root Cause Analysis and Investigation Report Writing - Online Self-Study Course - FDA, cGMP, QSR, GMP Training


You asked for it, so we delivered!

The most popular class with Allan Dewes, "Root Cause Analysis and Investigation Report Writing" is now available as an online self-study course.  In 3-1/2 hours you’ll learn about the tools used to conduct a thorough deviation investigation. You’ll also learn great tips and get clear guidance on how to write a deviation investigation report. This class is not just theory and offers clear examples. Private email-based coaching is also available.

Here’s what’s covered in the basic class:

     Root Cause Analysis
  • GMP Compliance Requirements
  • Deviation Investigation Definitions
  • Deviation Investigation Teams
  • Interviewing and Path Forward
  • Fishbone Diagrams
  • The Five Why’s Map
  • Distinctions
  • Walk-Through-Analysis
  • Change Analysis
  • Understanding Human Errors
  • Control Barriers
  • Product Impact
  • Previous Investigations (Look Back)
  • Immediate Actions
  • Containment
  • Corrections
  • Corrective Actions
  • Preventive Actions
  • Follow-Up and Effectiveness Checks
  • Risk Assessment

     Investigation Report Writing
  • Writing Tips
  • Writing the Description of the Event
  • Event Classification Reporting
  • Writing Immediate Actions and Containment
  • Reporting on Previous Investigations
  • Sequence of Events (root cause discussion)
  • Root Cause Summary
  • Writing about Product Impact
  • Reporting on Corrections and CAPA
  • Reporting the Follow-Up and Effectiveness Checks
  • Background Information, Attachments and Referential Information
  • Interim Reports

About The Coaching Option (an advanced option)
  • This optional purchase enables the student to practice each tool or report section. Each item is submitted to Allan for his review and evaluation. The student receives feedback. The purchase buys the student 4-hours of email-based coaching from Allan. Additional 4-hour blocks can be purchased if needed.
Fees:  
  • Basic Course access is $995 per student.
  • Advanced Coaching Option is $800 per student per 4-hour block of coaching time. Time is based on Allan’s actual document review time and preparing feedback. Additional review time segments can be purchased.
  • Special group or classroom rates are available.
Enroll Now:   Buy-Register-Enroll in Root Cause Analysis and Investigation Report Writing - An online self-study course

Certificates:  Students who successfully complete all topics will receive a certificate of completion via email from Allan.

Have More Questions:   Call Allan at 415.948.5220 or 954.873.7422 or Email at allan.dewes@skillsplusinc.com

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

 

Friday, December 22, 2017

CMC Changes for Biologics: FDA Offers Draft Guidance | RAPS

Read the full article: CMC Changes for Biologics: FDA Offers Draft Guidance | RAPS:

""The updated guidance applies to certain biological products licensed under the Public Health Service Act (PHS Act), including in vitro diagnostics licensed under BLAs," though it does not apply to human cells, tissues, and cellular and tissue-based products; specified biotechnology and specified synthetic biological products; and biosimilar biological products subject to licensure under section 351(k) of the PHS Act. "

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Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Friday, December 15, 2017

FDA Guidance: Regulations Under a Mask? | Bloomberg BNA

Read the full article:  FDA Guidance: Regulations Under a Mask? | Bloomberg BNA:

"The Washington Legal Foundation, a free-market advocacy group and think tank, is charging that the Food and Drug Administration is leaning too heavily on guidance documents in lieu of regulations, undercutting the Administrative Procedure Act and causing excessive burdens on affected industries. The group said the FDA has released more than 2,000 guidance documents and draft documents, far too many for industry to keep track of."

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Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
FDA cGMP QSR GMP Training Catalog & eBrochure - Courses, classes, workshops, and seminars
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

Wednesday, March 29, 2017