FDA releases statement underlining their powers to manage a selection of cannabis products

• cGMP Training & FDA Training Courses by SkillsPlus Intl Inc.

Read the entire press release:  FDA issues statement underlining their powers to manage a selection of cannabis products on FDA.gov

"Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. 

Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds."

Return to SkillsPlus International Info Blog - Home

As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

-----

• cGMP Training and FDA Training Courses by SkillsPlus Intl Inc.

-----

Read the full article:   As Partial Shutdown Continues, FDA Prepares To Furlough Employees - NPR.org

"Although most of the agency's employees weren't working over the weekend and on Monday and Tuesday because of federal holidays, FDA will furlough some 40 percent of its staff starting Wednesday. 

However, much of the agency's workforce will continue through the shutdown, with more than 10,000 FDA employees — nearly 60 percent — reporting to work, according to numbers released by the agency Friday."

Return to SkillsPlus International Info Blog - Home

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

 

Data Integrity and Compliance With Drug CGMP Questions and Answers - FDA.gov

• cGMP Training Courses and FDA Training Classes

Read the entire FDA guidance (pdf):  Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry - FDA.gov

"In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The underlying premise in §§ 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FD&C Act regarding safety, identity, strength, quality, and purity. Requirements with respect to data integrity in parts 211 and 212 include, among other things: . . . "

Return to SkillsPlus International Info Blog - Home

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

 

FDA plans to use ISO 13485 for medical devices regulation - ISO.org

• FDA cGMP QSR GMP Training - online training courses presented by SkillsPlus International Inc.

Read the full news article: FDA plans to use ISO 13485 for medical devices regulation - ISO.org

"The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally. 

ISO/TC 210 warmly welcomes the FDA’s planned adoption. This ISO technical committee, responsible for the quality management and corresponding general aspects for medical devices, is run by ANSI, ISO’s member in the United States."

Learn more about the proposed rule:

• RIN: 0910-AH99 - Title: Harmonizing and Modernizing Regulation of Medical Device Quality Systems
• Follow the status of the proposed rule on FDA.org (enter "0910-AH99" in the Search box)

Return to SkillsPlus International Info Blog - Home

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

 

RAPS Releases Results of Compensation Survey of Regulatory Professionals - RAPS.org

• GMP Trainer Certification Course - Online Self-Study

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

Read the full news article:  RAPS Releases Results of Compensation Survey of Regulatory Professionals - RAPS.org

"RAPS today released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organizations have evolved."

Navigate to the report:   2018 Global Compensation & Scope of Practice Report for the Regulatory Profession


Return to SkillsPlus International Info Blog - Home

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

 

FDA Released 3 DSCSA-Related Guidances - Healthcare Packaging

• Buy now to take one of these California Designated Representative Training Courses (approved by the California State Board of Pharmacy) for:  
       Wholesalers | 3PL | Reverse Distributors

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) - Earn a training affidavit

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

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

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

Pricing | Questions? - Call us (415) 948-5220

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

 

California Designated Representative Training Courses

California Designated Representative Training Courses

SkillsPlus International Inc. is the ONLY Board-approved provider of all three of the following online training programs.

• Buy a course now for: Wholesalers | 3PL | Reverse Distributors
• 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.

• Learn more & buy a training course:   http://www.dreprof.com/

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

California Designated Representative Training Courses - License applicants can earn a training affidavit

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

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

• CA Designated Representative Wholesaler Training 
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute
• Who offers California Designated Representative training? We do!

     Florida:

• FL Certified Designated Representative (CDR) Exam Prep Course 

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

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

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

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.

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

Pricing | Questions:   

• Call 415.948.5220 or 
• Email:  Send an email to Jennifer Payne - SkillsPlus International Inc.

Return to SkillsPlus International Info Blog - Home

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