Saturday, December 26, 2020

The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm - Medtech Insight

According to the article:

"Executive Summary

From our archives: Despite the COVID-19 pandemic severely curtailing the US FDA’s ability to conduct on-site facility inspections, it’s still vitally important for manufacturers to remain audit-ready. In this collection of a 10-part Compliance Corner series, four longtime industry experts share evergreen advice on the best and worst things firms could do during an inspection."

Read the full source article:  The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm - Medtech Insight

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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!

 

Tuesday, December 22, 2020

FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

Updated March 4, 2021

FDA Misses Fifth Target Date For Issuing Draft Harmonized Quality System Reg - Medtech Insight

---  original post follows below  ---

According to the article:

"February 2021 is the latest target date selected by the US agency for releasing a draft of its retooled QSR, which has been undergoing a facelift for more than two years to harmonize it with international quality systems standard ISO 13485.  ...

This is the fifth in-house deadline the FDA has set for issuing its draft rule, which will harmonize the QSR with international quality systems standard ISO 13485:2016. The agency had previously set deadlines of April 2019, September 2019, April 2020 and October 2020."

Read the full article:  FDA Picks New Target Date For Releasing Its Draft Harmonized Quality System Regulation - Medtech Insight

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-----------

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!

 

Monday, November 16, 2020

Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency - FDA Guidance

View the source FDA Guidance:  Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency - Guidance for Industry (PDF)

According to the guidance:

"FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply."

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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!

 

Friday, October 16, 2020

Analysis: Is the Trump Administration Eroding Trust in the FDA? - Government Executive

Read the full source article:  Analysis: Is the Trump Administration Eroding Trust in the FDA? - Government Executive

According to the article:

"The FDA has spent decades establishing a science-based framework for rigorously reviewing products and must be allowed to apply it without political interference, said Ledley. “I’m not confident this will happen,” he added. Neither are seven former FDA commissioners who, in an op-ed for The Washington Post, expressed concern that the Trump administration’s fingerprints were all over FDA decision making — not just in encouraging the agency to promote unproven treatments, but also in curbing its rule-making authority and trying to rush approval of a vaccine. Those politically motivated actions, they argued, are eroding the public’s confidence in any vaccines that gain approval — and public health authorities in general."

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


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!

 

Monday, October 5, 2020

Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

Read the full article:   Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

According to the article:

"The FDA originally published a Notice of Proposed Rule Making (NPRN) in May 2018. The abstract from Regulation Identifier Number (RIN) 0910-AH99 states: “FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufactures, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.” The NPRM is currently at the Proposed Rule Stage with an action date in October 2020. A panel committee meeting will be held after issuance of the proposed rule."

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!

 

Wednesday, September 23, 2020

FDA Launches the Digital Health Center of Excellence - FDA.gov

According to the FDA press release:

"Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.


“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.”"

Read the full press release: FDA Launches the Digital Health Center of Excellence - FDA.gov

Go to the: Digital Health Center of Excellence - FDA.gov

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-----

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!

 

Wednesday, September 16, 2020

FDA cGMP QSR GMP Training - online training courses by SkillsPlus Intl Inc.

In 8 one-hour segments learn what the experts know about the CGMPs for Pharmaceutical and Biotech manufacturing. 

Ask yourself these three questions:
  1. Do you need to conduct CGMP Training on a limited budget? 
  2. Do you want employees to learn the CGMPs from an expert using real examples? 
  3. Do you need CGMP Training resources suitable for multiple levels of the organization?
If you answered YES to any of these three questions then you should take a look at the courses below:
  • 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
  • Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
  • Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
  • Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
  • Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
  • Plan to Production - Part F. Review the requirements for production process controls and validation.
  • Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
  • Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
  • Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.


FDA GMP QSR cGMP Training - online training classes by 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!

 

Sunday, August 23, 2020

Online DRIC Training Courses - California Designated Representative Training Courses

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

California Board of Pharmacy Designated Representative Training Courses for DRIC* by SkillsPlus Intl Inc.

If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses.

SkillsPlus International Inc. proudly offers three (3) distinct Board-approved Designated Representative online training courses. Each one is specifically designed for:

  • drug/device wholesalers
  • 3PL (third-party logistics providers)
  • reverse distributors

About Our Courses:

  • All 3 of our online training programs are approved by the California State Board of Pharmacy
  • Online training classroom available 24 x 7
  • More than 7,000 students have taken our state license-related courses
  • Offered continuously since 2002

California Board of Pharmacy Designated Representative Training Courses for DRIC* by SkillsPlus Intl Inc.

Learn more or buy now:  California Board of Pharmacy Designated Representative Training Courses by SkillsPlus International Inc. - for wholesalers, 3PL, or reverse distributors. Board Approved!


* DRIC:

DRIC
Designated Representative In Charge (California)

Keywords and Phrases:

California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; online; web; eLearning; provider; vendor; seller; DRIC

Wednesday, August 19, 2020

Medical Device Shortages During the COVID-19 Public Health Emergency - FDA.gov

According to the FDA article:

"One provision of this new statutory authority—section 506J(g) of the FD&C Act— requires the FDA to maintain a publicly-available, up-to-date list of the devices the FDA has determined to be in shortage. In addition, the FDA is providing a list of medical devices for which the FDA has been notified that manufacturing has been permanently discontinued. The list below fulfills this statutory obligation and reflects the categories of devices the FDA has determined to be in shortage at this time, and will be maintained and updated as the COVID-19 public health emergency evolves."

Read the full source article, and view the list:  Medical Device Shortages During the COVID-19 Public Health Emergency - FDA.gov

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

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!

 

Tuesday, August 11, 2020

Designated Representative - Wholesaler License - California State Board of Pharmacy

Designated Representative - Wholesaler License - California State Board of Pharmacy


According to the Board, "To be licensed as a Designated Representative in California, you must satisfy the requirements under Business and Professions Code section 4053. Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations."

Download the Designated Representative - Wholesaler License Application Form - California State Board of Pharmacy

California Board of Pharmacy Designated Representative Wholesaler Training Course 


If you are applying for a California Designated Representative Wholesaler license, then you’re also going to need to include proof of required training in your license application packet.

The proof of required training is a form called the training affidavit. You can earn a training affidavit by taking a California Designated Representative training course approved by the Board.

Learn more and enroll in California Board of Pharmacy Designated Representative Wholesaler Training Course — presented by SkillsPlus International Inc.

  • This course is approved by the California Board of Pharmacy.
  • Designed specifically for drug/device wholesalers
  • Successful class completion earns a training affidavit accepted by the Board, to include in your Designated Representative license application.
  • More than 6,000 students have taken our courses
  • SkillsPlus International Inc. has deep experience, offering a Designated Representative training course continuously (without interruption) since 2002.
  • Our online courses run on popular devices and operating systems.

Learn more and buy California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved.


Keywords and Phrases
California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; form; online; web; eLearning; provider; vendor; seller; taught by; presented by; buy; purchase; enroll; register; wholesaler

Wednesday, July 15, 2020

Designated Representative - 3PL License - California State Board of Pharmacy

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

Designated Representative - 3PL License - California State Board of Pharmacy


According to the Board, "To be licensed as a Designated Representative - 3PL in California, you must satisfy the requirements under Business and Professions Code section 4053.1. Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider’s customer specifications, except where the customer’s specifications conflict with state or federal laws. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager."

Download the Designated Representative - 3PL License Application Form - California State Board of Pharmacy

California Board of Pharmacy Designated Representative 3PL Training Course 


If you are applying for a California Designated Representative 3PL license, then you’re also going to need to include proof of required training in your license application packet.

The proof of required training is a form called the training affidavit. You can earn a training affidavit by taking a California Designated Representative training course approved by the Board.

Learn more and enroll in California Board of Pharmacy Designated Representative 3PL Training Course — presented by SkillsPlus International Inc.

  • This course is approved by the California Board of Pharmacy.
  • Designed specifically for third-party logistics providers (3PL)
  • Successful class completion earns a training affidavit accepted by the Board, to include in your Designated Representative license application.
  • More than 7,500 students have taken our courses
  • SkillsPlus International Inc. has deep experience, offering a Designated Representative training course continuously (without interruption) since 2002.
  • Our online courses run on popular devices and operating systems.

California Board of Pharmacy Designated Representative 3PL Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved.
Learn more and buy California Board of Pharmacy Designated Representative 3PL Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved. 

Keywords and Phrases
California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; form; online; web; eLearning; provider; vendor; seller; taught by; presented by; buy; purchase; enroll; register; 3PL; third-party logistics provider

Tuesday, July 14, 2020

FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma

Read the full source article:

FDA complicates 'chaotic' federal COVID-19 response with pledge to resume domestic inspections - Fierce Pharma


According to the article:

"The FDA will resume "prioritized" domestic manufacturing inspections the week of July 20 after a four-month moratorium on most on-site walkthroughs, FDA Commissioner Stephen Hahn, M.D., said in a release Friday. 
However, a troubling uptick in new COVID-19 cases and deaths means the agency will weigh local virus activity when deciding which sites to inspect, and that fact had analysts questioning the FDA's announcement."

Read the FDA Statement, Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system - FDA.gov

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!

 

Monday, July 13, 2020

HMDR Exemptee Application: CDPH 8695

California Department of Public Health (CDPH)— Food and Drug Branch — HMDR Exemptee Application: CDPH 8695 for home medical device retailers


  • Register to take California HMDR Exemptee Certification Training — an online training class presented by SkillsPlus International Inc.  - - -  $525 per student. No extra fees to retake quizzes. Earns a course completion certificate accepted by the CDPH.

  • Download The HMDR Exemptee Application


    HMDR Exemptee Training Certification


    If you’re looking for, or need, the Exemptee application form, then you might also need a California HMDR Exemptee Training Certification Course. The Exemptee application process requires submitting proof that you’ve taken a class that covers required training topics specified on the Exemptee application.

    Upon successful completion of California HMDR Exemptee Training — presented by SkillsPlus International Inc. you’ll earn a course completion certificate accepted by the CDPH, to include with your HMDR Exemptee application packet. This course is approved by the CDPH.



    FAQ - California HMDR Exemptee Training

    Question: Who offers California HMDR Exemptee Training Certification?
    Answer: SkillsPlus International Inc. is a highly recommended provider of California Exemptee certified training for home medical device retailers (HMDR).

    Keywords & Phrases
    California Department of Public Health. Food and Drug Branch. Home Medical Device Retail. Home Medical Device Retailer. #HMDR #HME #DME #HMDRexemptee #Exemptee #accepted #approved #certified #online #web #training #program #certificate #certification #course #class #webinar #seminar #workshop #event #provider #vendor #seller #presenter #registration #enroll #register #buy #purchase

    Tuesday, July 7, 2020

    Designated Representative License Application - California State Board of Pharmacy

    Designated Representative - California Board of Pharmacy - License Application Forms

    Here's where to find the Board's collection of California Designated Representative personal license application forms:
    • Wholesaler/Non-Resident Wholesaler
    • 3PL (third-party logistics provider)
    • Reverse Distributor

    California Board of Pharmacy Designated Representative Training Course(s)

    If you are applying for a California Designated Representative license, you're also going to need training specified by the Board.

    A complete California Designated Representative license application consists of several forms and documents. The Board requires proof of training documentation, specifically, a training affidavit. A training affidavit is typically provided by a training company upon successful course completion.

    Here's how to learn more and register for a Board-approved California Board of Pharmacy Designated Representative training course (wholesaler, 3PL, reverse distributor). Presented by SkillsPlus International Inc. Board approved. Earns a training affidavit accepted by the Board. Online course pricing starts from $525 per student.

    Here's how to learn more and register for a Board-approved California Board of Pharmacy Designated Representative training course (wholesaler, 3PL, reverse distributor). Presented by SkillsPlus International Inc. Board approved. Earns a training affidavit accepted by the Board. Online course pricing starts from $525 per student.
    Here's how to learn more and register for a Board-approved California Board of Pharmacy Designated Representative training course (wholesaler, 3PL, reverse distributor). Presented by SkillsPlus International Inc. Board approved. Earns a training affidavit accepted by the Board. Online course pricing starts from $525 per student.


    Keywords and Phrases
    California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; form; online; web; eLearning; provider; vendor; seller; taught by; presented by; buy; purchase; enroll; register

    Saturday, April 25, 2020

    Florida Certified Designated Representative (CDR) Training, Exam Prep, And More!


    Over the years, we've fielded many questions revolving around the Florida Certified Designated Representative license.  Of chief interest, is how to go about preparing for the State of Florida Certified Designated Representative Laws & Rules Examination.

    I've invited Dr. Sharon B. Roberts* (an expert in the regulatory realm of pharmaceuticals and wholesale drug distribution, and founder of CDR Resource Center) to share some thoughts and introduce the services that CDR Resource Center can provide:

    • Florida Certified Designated Representative (CDR) laws and rules examination preparation
    • Consulting expertise in prescription drug regulations and wholesale distribution compliance

    Online Florida CDR Training By CDR Resource Center - Automated Online Training & Testing


    All Prescription Drug Wholesale Distributors (including virtual BROKER -ONLY), companies that are seeking to do business in or with the State of Florida, are required to have a full-time Florida licensed Certified Designated Representative, (CDR). To become a FL licensed CDR a candidate must pass a laws and rules exam administered by the State of Florida.  CDR Resource Center has been training FL CDR candidates for over 12 years for the very difficult State exam.

    Training for the State exam is offered in three ways:
    1. CDR Resource Center offers online virtual training allowing the candidate to study at their own pace from any computer.  The virtual training consists of 15 modules of educational and study materials, 100s of sample test questions and timed mock 40 question final exam. Register for FREE on our website - Try a quick FREE sample of the module style online training
    2. For the student who would prefer a live instructor, CDR Resource Center offers an 8 hour Webex with a live trainer.  The live training includes a bound law and rules manual, a pre-test, 7 hours of lecture and a post-test.   The live training can be purchased online in the Compliance Consulting section of the cdrresourcecenter.com
    3. For the candidate who has taken the State exam already and does not want to take a full course, we offer hourly consulting.  Bring us all your questions and purchase as much time as you’d like.  We can discuss your questions and point you to the correct answers. 

    Additional CDR Resource Center Services


    CDR Resource Center also provides state licensing support for the drug industry. Our company's licensing support services is unique to the industry allowing companies to pay as they go with no upfront onboarding fees or contracts


    *About Our Guest Blogger - Sharon B. Roberts


    Photo of Sharon Roberts, PharmD, JD, CDR
    Sharon Roberts, PharmD, JD, CDR
    Sharon Roberts, PharmD, JD, CDR has over 25 years in the Pharmaceutical industry as a Registered Pharmacist and practicing Florida lawyer. She then became licensed as a Certified Designated Representative (CDR) and worked for the Department of Business and Professional Regulation Drug, Device and Cosmetics Program of the State of Florida where she was a State Inspector/Drug Agent inspecting businesses involved in the manufacture, purchase, storage and sale of prescription and over-the-counter drugs, devices and cosmetics. As part of this experience she became intimately familiar with the Florida Drug, Device and Cosmetic Act. The contents of this Act are the basis of the studies required to become a State Certified Designated Representative (CDR). Combining all her experience, she founded CDR Resource Center which offers over 25+ years of experience in the regulatory realm of pharmaceuticals and wholesale drug distribution.

    Wednesday, April 1, 2020

    The Most Popular GMP Courses Taught By SkillsPlus International Inc.

    SkillsPlus International Inc. was originally incorporated in 1991. While serving the needs of over 500 clients and customers world-wide, it is our mission to provide quality training and consulting services that meet the needs of the client organization.

    Allan Dewes, President of SkillsPlus International Inc., possesses over 30 years experience in identifying training needs, and creating and delivering practical, cost-effective training solutions for CGMP, GCP, GLP, QSR, management, and supervisory development.  Mr. Dewes and his training team facilitate classes for all levels of the organization.  

    What follows below is a small selection of our most popular cGMP training courses.


    Root Cause Analysis & Deviation Investigation Report Writing


    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.

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


    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.




    GMP Trainer Awareness, Certification, and Master Trainer Courses


    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. 

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

    How This Course Is Implemented


    This course is implemented in three phases: Awareness, Certification, and Master Trainer. 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.

    GMP Trainer Awareness – Students view presentations covering the course objectives below.

    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.

    GMP Master Trainer – Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.

    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



    GMP eLearning - Online  Courses


    Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses


    Ask yourself these three questions:

    1. Do you need to conduct CGMP Training on a limited budget? 
    2. Do you want employees to learn the CGMPs from an expert using real examples? 
    3. Do you need CGMP Training resources suitable for multiple levels of the organization?

    If you answered YES to any of these three questions then you should take a look at the courses below:

    • 21CFR211 - Learn the highlights of the Current Good Manufacturing Practice Regulations.
    • Your Personal Responsibilities - Part B. Review the requirements for personnel working in the pharmaceutical industry.
    • Foundation to Facility - Part C. Dive into the requirements for the design, cleaning & maintenance of a facility.
    • Maintaining Compliant Equipment Practices - Part D. Examine the requirements for the design, cleaning & maintenance of equipment.
    • Supplier to Plant - Part E. Explore the requirements for the receipt, storage and use of all components.
    • Plan to Production - Part F. Review the requirements for production process controls and validation.
    • Plant to Patient - Part G, H, & K. Examine the requirements for packaging, labeling, warehousing and distribution.
    • Laboratory to Release - Part I. Dive into the requirements for laboratory controls, method validation, stability and more!
    • Proper Documentation Practices - Part J. Examine the requirements for proper paper and electronic documentation practices.

    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!

     

    Saturday, March 21, 2020

    California Designated Representative Courses

    California Designated Representative

    California Designated Representative Courses for:
          Wholesalers | 3PL | Reverse Distributors

    • online training courses available 24 x7
    • approved by the California State Board of Pharmacy
    • 3 distinct courses for:  wholesalers, 3PL, reverse distributor
    • prices start at $525 per student
    • earns a training affidavit recognized by the Board
    • more than 7,000 students have taken our state license-related training programs
    California Designated Representative Courses - for wholesalers, 3PL, reverse distributors
    California Designated Representative Courses - for wholesalers, 3PL, reverse distributors

    Thursday, March 19, 2020

    Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections - FDA.gov

    Read the full FDA Statement:  Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections - FDA.gov


    In the statement:
    "Today, we’re announcing that for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products."

    Return to SkillsPlus International Info Blog - Home

    Tuesday, February 4, 2020

    Exemptee Training - SkillsPlus Intl Inc

    California HMDR Exemptee online training certification class

    We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. 

    If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate accepted by the CDPH - include it in your license application.

    Earns a course completion certificate accepted by the California Department of Public Health - Food and Drug Branch. Covers required topics specified in the Exemptee license application form.
    More than 7,500 students have taken our state license-related training programs.


    California HMDR Exemptee online training certification class - $525 per student
    California HMDR Exemptee online training certification class - $525 per student. No extra fees to retake quizzes.