Wednesday, October 10, 2018

Friday, October 5, 2018

FDA Released 3 DSCSA-Related Guidances - Healthcare Packaging

----------------

----------------

Read the full article:   ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

According to the article, the FDA released the following guidances:
  1. Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers Guidance for Industry (PDF)
  2. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF)
  3. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy (PDF)

Return to SkillsPlus International Info Blog - Home

---------------------------

California Designated Representative Training Courses (approved by the California State Board of Pharmacy)
California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - Earn a training affidavit

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Monday, August 13, 2018

GMP Trainer Awareness, Certification, and Master Trainer Certification Course

This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization.
GMP Trainer Courses

How This Course Is Implemented


This course is implemented in three phases: Awareness, Certification, and Master Trainer.
  1. GMP Trainer Awareness - Students view presentations covering the course objectives below.
  2. GMP Trainer Certification - Students view the “Awareness” presentations. Students then prepare elements of a training session demonstrating the application of the content taught in the awareness course, or in some cases, capture and submit video segments of an actual or practice training session. All information submitted will be reviewed and critiqued by a team of Master Trainers. This course is taken simultaneously with the Awareness course.
  3. GMP Master Trainer - Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.
This is NOT a public seminar workshop. Our public seminar was so popular; we turned it into an online self-study course that fits into your busy schedule.


In this course, you will learn how to:

  • Apply a Participant Centered Approach to training
  • Write course objectives
  • Development a course assessment
  • Describe the difference between ice breakers and activities
  • Describe and develop ice breakers for a class
  • Describe and develop activities for a class
  • Explain the role of the instructor during activities
  • Develop an activity debriefing strategy
  • Describe various strategies for forming groups
  • Design a course presentation
  • Identify and demonstrate effective presentation skills
  • Develop stories for a class and how to deliver the story
  • Develop discussion questions
  • Develop and implement discussion follow-up strategies
  • Demonstrate the management of disruptive behavior
  • Identify the elements of a course assessment validation plan
  • Identify the elements of a course evaluation form
  • Develop a course evaluation form
Keywords:  #FDA #cGMP #GMP #QSR Train The Trainer T4T

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, June 27, 2018

California Designated Representative Training Courses

California Designated Representative Training Courses

  • SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy.
  • Earn a training affidavit (accepted by the California Board of Pharmacy)

What is the California Designated Representative training affidavit?

  • The California Designated Representative license application forms are lengthy and involved.  A lot of information needs to be provided, and a lot of documents must be submitted.
  • One document that needs to be submitted is the "Training Affidavit."
  • The training affidavit is one of many forms that makes up the complete license application package.  In order to get a training affidavit, the license applicant needs to go through a training program.  The training program is commonly sold as a training course, training class, or training seminar.  Upon successful completion of a training course, the course administrator issues proof of completion, in the form of a training affidavit.

How To Earn A Training Affidavit

1. Find a training program that is accepted by the California Board of Pharmacy.  We suggest our California Designated Representative training courses.
  • Our courses are available online 24 x7
  • We have a long track record. We've trained more than 5,000 students.
2. Make sure you take the correct course that's appropriate for your license application.  Specifically, there are several types of California Designated Representative license applications (including, but not limited to):
  • California Designated Representative - Wholesaler
  • California Designated Representative - 3PL (third-party logistics provider)
  • California Designated Representative - Reverse Distributor
3. Complete the training program to earn a training affidavit. Include the training affidavit in your license application package.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit - accepted by the California Board of Pharmacy):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate - accepted by the CA Dept of Public Health):

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

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!