Friday, July 12, 2019

Report On The State Of Pharmaceutical Quality - FDA.gov


Center For Drug Evaluation And Research - Office Of Pharmaceutical Quality

Report On The State Of Pharmaceutical Quality - FDA.gov

Assuring quality medicines are available for the American public


The report is a good read.  It's data-rich, and provides a good overview.

This comes from the report's introduction:

"The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) monitors the quality of CDER-regulated drugs legally marketed in the U.S. A quality drug is consistently safe and effective, free of contamination and defects. Patients and consumers expect quality drugs with every dose they take. The ‘State of Pharmaceutical Quality’ is a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products."

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Thursday, July 11, 2019

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov

Read the FDA article: What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov


According to the FDA article:

"The FDA is committed to sound, science-based policy. The FDA is raising these safety, marketing and labeling concerns with you now because we want you to know what we know. We hope that you will provide any data that you have to the public docket.
Today’s Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make smart choices about CBD products. Also, as the regulatory pathways are clarified we will take care to notify all stakeholders as quickly as possible.

Saturday, May 11, 2019

SkillsPlus International Inc. Announces Online GMP e-Learning Courses

SkillsPlus International Inc. proudly announces  the reintroduction and updating of our very popular GMP e-learning courses. 


Do you need . . . ?

  • New employee GMP training awareness that is quick and easy?
  • Annual refresher training that is on a flexible schedule for team members?
  • Training solutions that are responsive to a demanding production environment?


Our LMS GMP Training solution is the answer to your needs!


  • A current list of topics is available.
  • 24-7 Availability
  • An ever growing list of topics is planned.
  • Our pricing is structured for today’s tight budgets


Additional Features

  • Private classrooms allow your company trainer to share notes to all your employees.
  • Trainers can be identified as classroom monitors to tracking student grades and completion.


Online Courses Currently Available

  1. 21 CFR 211: Pure, Safe and Effective – An overview to of the Current Good Manufacturing Practice Regulation.
  2. Proper Documentation Practices – An explanation of the GDPs for paper and electronic records.
  3. Equipment – A review of equipment related GMPs.
  4. Root Cause Analysis – An in-depth examination of the most effective tools for investigation deviations. Individual deviation specific feedback and coaching is available.
  5. Investigation Report Writing – This course offers an in-depth examination of the FDA and QA expectations for writing a comprehensive investigation report. Individual report specific feedback and coaching is available.


Email us for a quote:  skillsplus@aol.com

FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.
FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.


Saturday, April 6, 2019

FDA & FTC Crack Down on CBD False Medical Claims - HealthcarePackaging.com

Read the full article:  FDA & FTC Crack Down on CBD False Medical Claims - HealthcarePackaging.com

"The FDA and FTC sent warning letters to three CBD companies making false claims about treating diseases like cancer and Alzheimer’s." 
"The letters claim the companies are falsely advertising the effectiveness of supplements to treat diseases including cancer, Alzheimer’s, fibromyalgia, and neuropsychiatric disorders. This marks the first time the FDA and FTC have issued a joint warning letter together."


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

 

Friday, March 1, 2019

FDA Issues Guidance On Continuous Manufacturing

Quality Considerations for Continuous Manufacturing - Guidance for Industry


The guidance provides information regarding the FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER). The guidance describes several key quality considerations and provides recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small molecule, solid oral drug products that are produced via a continuous manufacturing process. FDA supports the development and implementation of continuous manufacturing for drug substances and all finished dosage forms where appropriate, including those submitted in NDAs, ANDAs, drug master files (DMFs), biologics license applications (BLAs), and nonapplication over-the-counter (OTC) products. Scientific principles described in the guidance may also be applicable to continuous manufacturing technologies used for these drugs. However, the guidance is not intended to provide recommendations specific to continuous manufacturing technologies used for biological products under a BLA.

Source:  Quality Considerations for Continuous Manufacturing - FDA Guidance for Industry (PDF)

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

 

Monday, February 11, 2019

FDA Signals Strengthening Regulation of Dietary Supplements - FDA.gov


Read the full press announcement:  Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

Snippets from the FDA Commissioner's statement:
". . . we are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.

One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law.

As part of our comprehensive efforts, today we sent 12 warning letters and five online advisory letters to companies  whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer."


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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 28, 2018

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

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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."

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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!

 

Tuesday, December 25, 2018

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

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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."

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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!

 

Thursday, December 20, 2018

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

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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: . . . "

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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, October 10, 2018

Friday, October 5, 2018

FDA Released 3 DSCSA-Related Guidances - Healthcare Packaging

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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)

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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

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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

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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 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. "

'via Blog this'

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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."

'via Blog this'

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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!