Make A New Year Resolution - Take A GMP Trainer Certification Course

Updated December 27, 2021

You might also be interested in the online distance learning version of our highly popular GMP Trainer Certification Course - taught by SkillsPlus International Inc:

GMP Trainer Awareness, Certification, and Master Trainer Courses. 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.

- - -   original post follows below   - - -

SkillsPlus Intl Inc.'s next public seminar of the highly popular GMP Trainer Certification Course is May 5-9, 2014 in Fort Lauderdale, FL.  Learn more: http://www.skillsplusinc.com/Pub_Sem.htm

This is a life-changing five-day class in which participants experience many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization.

Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.

1. Upon course completion, participants will be able to:
2. Explain the essentials of the CGMP/QSR regulations. 
3. Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions. 
4. Demonstrate techniques to present CGMP/QSR content in memorable ways.
5. Design and conduct activities that reinforcement learning. 
6. Facilitate discussions and questions like a pro. 
7. Respond to difficult questions.
8. Deal successfully with difficult students. 
9. Manage class room media. 

Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Merry Christmas!

• Recommended FDA cGMP online training courses, classes, and programs offered by SkillsPlus International Inc.

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT

cGMP Procedure (SOP) Writing Course

Updated October 28, 2022

The mentioned course is no longer available.

The list of online courses offered by SkillsPlus International Inc. has been expanded. 

Learn more >>  CGMP Online Training Courses by SkillsPlus International Inc.

---   the following course is no longer available  ---

483 Observation Gotchas!

 

1. Firm's procedures lack sufficient detail.

2. Employees perform significant steps not included in procedures.

3. Firm lacks procedures for a variety of production, maintenance, and quality assurance activities.

Planning for Training 2014!

 2014 is just around the corner! 

• Does your company constantly update and revise procedures, or
• Are procedures the root cause of many deviations, or
• Are procedures ignored, being replaced by word-of-mouth guidance from colleagues?

If you answered "Yes" to one or more of these questions, then you need to take a look at our Writing Standard Operating Procedures workshop.

Featured Course

Writing Procedures: This course is as much about consulting as training. In this course, Allan reviews and consults on a firm's procedure for writing procedures, and then coaches employees on procedure writing. Employees work with existing or needed procedures in this workshop.

Tools addressed in this very popular workshop:
1. Readability analysis

2. Task analysis

3. Decision-making through procedures

4. Determining the appropriate level of detail

5. Task grouping for greater comprehension

6. Procedure reviews and more!

 

If your firm is not satisfied with the quality of procedures, then you need to look into our Writing Procedures workshop!

Return to SkillsPlus International Info Blog - Home

FDA Prepares Compounding Blacklist of Banned Products - RAPS RF

• People also ask about FDA GMP Online Training - respected FDA CGMP online training courses provided by SkillsPlus International Inc.

FDA Prepares Compounding Blacklist of Banned Products - RAPS RF:

"In a Federal Register announcement on 2 December 2013 — just days after the DQSA was signed into law — FDA said it wanted public input on which drugs should comprise such a list.

"To identify candidates for the difficult-to-compound list, FDA is seeking public input in the form of specific drug products or categories of drug products that are difficult to compound," the agency wrote."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA aims to oversee drug compounders - USA Today

FDA aims to oversee drug compounders - USA Today:

""We will be encouraging health care providers and health networks to consider strongly purchasing compounded products from FDA-registered and regulated facilities," FDA Commissioner Margaret Hamburg says. "This will be a critical step they can take to better assure the health and safety of their patients."

Outsourcing facilities will also be required to report specific information about the products they compound, including a list of all the products compounded during the previous six months, and details about the source of the active ingredient, as well a report known as adverse effects."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

The Best GMP Trainers are . . .

Updated March 14, 2021

You might also be interested in our online version of the course:

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

--- original post follows below  ---

If you're a trainer, here's some food for thought.

Rob Packard of the Medical Device Academy was quoted on LinkedIn, "that there are four prerequisites for a great Instructor:

1. The instructor must be an expert.
2. The instructor must inspire participation.
3. The instructor must provide practical examples for each student.
4. The instructor must get everyone’s attention – and keep it."

If Rob's wise words resonate with you, then consider joining us for our highly recommended, and extremely popular GMP Trainer Certification Public Seminar (click to learn more). 

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA Acronyms and Abbreviations - An FDA Terms and Definitions Search Tool

• FDA CGMP Online Training - Respected FDA GMP online training courses offered by SkillsPlus International Inc.

FDA Acronyms and Abbreviations: <---   "Search for an Acronym or Abbreviation:"

Use the search tool provided on the FDA's website, to search for abbreviations and acronyms used in the FDA regulated industries.

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Return to SkillsPlus International Info Blog - Home

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

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

 

Giving FDA.gov Visitors a New Mobile Experience

Updated June 26, 2024

The original link broke.

You might also like:

Consumer Updates - Science-based health and safety information you can trust - FDA.gov

---  the original post follows below  ---

Consumer Updates > Giving FDA.gov Visitors a New Mobile Experience:

"FDA just launched a new version of its website that works well with the most popular mobile devices, including smartphones and tablets, while continuing to support traditional desktop and laptop computers."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

GMP Training - The cGMP Essentials Course

Updated October 31, 2024

The original post didn't age very well.

You might also be interested in:

CGMP Training: A New Generation - Course Descriptions - Training by SkillsPlus International Inc.

---  the original post follows below  ---

483 Observation Gotchas!   1. There is no documented training in CGMPs. 2. CGMP training has not been conducted for over three years. 3. Firm lacks qualified CGMP trainers.      Planning for Training 2014!  2014 is just around the corner!  Do you need to get CGMP and related training completed and do not have the staff, or Are you and your staff already overloaded, or Do you just need a new and exciting approach to CGMP training? If you answered "Yes" to one or more of these questions, then take a look at our CGMP Essentials course. Learn More About the SkillsPlus CGMP Essentials course   Featured Course CGMP Essentials: This course can be structured with more than two dozen different training activities designed to reinforce learning and keep employees engaged. Prior students have high praise. One manager said, "I never knew CGMP training could be so much fun." One former FDA Inspector reported, "I actually learned something."   Topics addressed in this very popular course: 1. Heard on the Street 2. Review of 21 CFR 211 Subparts 3. Essential Quality System Tools 4. Consequences for non-compliance, and more!   If your firm needs a fresh new look at CGMP training, then you need to look into our CGMP Essentials course!   Examine The CGMP Essentials Course Outline

Recommendations for 2014 GMP Training - Executive Session: What Leadership Needs to Know

 

483 Observation Gotchas!

 

1. Firm lacked an effective training program to ensure all employees, including upper management, are fully trained on CGMPs.

2. Management failed to prevent non-controlled documents from being in the dispensing area.

3. Management did not understand their role & responsibility in supporting & enforcing the quality system.   

 

 

Planning for Training 2014!

 2014 is just around the corner! 

1. Can't get management staff to attend your CGMP training sessions, or
2. Not quite sure what to present to management staff for annual CGMP training, or
3. Does management feel that they do not need to attend annual CGMP training?

If you answered "Yes" to one or more of these questions, then you need to take a look at our Executive Session 2014 CGMP Update.

Learn More About the SkillsPlus Executive Session 2014 CGMP Update Course

  

 

Featured Course

Executive Session 2014 CGMP Update: This course focuses on what the executive needs to know. There's no discussion of "single-line through ... yada, yada, yada," in this course.

 

Topics addressed in this intense update:

1. Annual observation update

2. What the observations mean to executives and managers

3. Consequences

4. Interesting court cases

5. Current trends and more!

 

If your firm needs to get some of your executives and managers into meaningful CGMP training, then you need to look into our Executive Session 2014 CGMP Update!

Examine The Executive Session Outline

 

Allan Dewes, President.

 

About Your Instructor

Allan Dewes

Allan Dewes has been training CGMP for over 30 years, including managers and executives. Allan knows how to adjust his comments and focus on the needs of executives and managers.

Email today to request a quotation

 

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Dietary Supplement Firms Still Violating Basic Manufacturing Rules - NPI

Updated September 4, 2024

The original link broke.

You can still read about the same topic here, on Natural Products Insider:

https://www.naturalproductsinsider.com/manufacturing/fda-still-finds-basic-gmp-violations-in-supplement-industry

---  the original post follows below  ---

Dietary Supplement Firms Still Violating Basic Manufacturing Rules - Natural Products Insider:

"FDA has been bringing down the hammer on one out of three dietary supplement firms for failing to comply with cGMPs. Through the first several months of fiscal year 2013, of the 350 cGMP inspections FDA originally designated and concluded as falling under Part 111, the agency's 19 district offices collectively classified 33 percent, or 117 businesses, as OAI (official action indicated)."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Ideas For 2014 GMP Training - Deviation Investigation Report Writing Clinic

483 Observation Gotchas!

 

1. Deviation reports failed to include a discussion of product impact.

2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.

3. Investigation reports failed to provide data to support the root cause determination

 

Planning for Training 2014!  2014 is just around the corner!  Do your investigation reports wander all over and never get to the point, or Do deviation reports fail to document a sound root cause conclusion, or Do deviation report writers never seem to know what Quality Assurance wants discussed in the report? If you answered "Yes" to one or more of these questions, then take a look at our Investigations Report Writing clinic.

 

Featured Course Deviation Investigation Report Writing Clinic: This course is hands-on and personal. In this clinic, students: learn about each section of your company's investigation report; write each section of the report for a real investigation report, and then; receive personal coaching privately from Allan. This course is not the typical spelling and grammar checking training program often offered.   Common sections addressed in this very popular workshop: 1. Deviation Description 2. Previous Related Investigations 3. Product Impact Assessment 4. Root Cause Investigation Discussion 5. Root Cause Determination 6. Risk Assessment 7. Corrective and Preventive Actions and more!   If your firm is not satisfied with the quality of deviation investigation reports, then you need to look into our Deviation Investigation Report Writing Clinic!   Examine The SkillsPlus Investigation Report Writing Clinic Outline

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA Proposal - Head Off More Drug Shortages

Updated December 19, 2020

You might be more interested in this:

Drug Shortages - FDA.gov

- - -  original post follows below  - - -

FDA proposal aims to head off more drug shortages:

"The Food and Drug Administration announced a new proposal Thursday to try and head off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide.

Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply. That includes plans to discontinue a product or manufacturing changes that could slow production."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

2014 GMP Training Ideas - GMP Olympics Refresher Course

Updated September 26, 2022

The GMP training course described in the original post is no longer offered.

People also search for:

FDA GMP online training programs and classes offered by SkillsPlus International Inc.

---  the original post follows below  ---

Plan for cGMP Training 2014!  2014 is just around the corner!  Do your employees avoid CGMP training, claiming they've heard it all, or Do they resist attending CGMP training because "their" job is never discussed, or Do some employees "drift off" in CGMP training because it is too theoretical? If you answered "Yes" to one or more of these questions, then you need to take a look at our GMP Olympics Refresher course.

Featured Course GMP Olympics 2014: Become a participant in the Olympics! This course challenges even the most seasoned employee's knowledge of CGMPs. This course is definitely not for new employees who are new to the industry. Activities from this highly interactive workshop: 1. Heard on the Street 2. Team-based regulation review 3. GMP Challenge 4. Inspection Detection, and more! This course can be customized to meet a variety of content and time constraints. Examine the GMP Olympics 2014 Course Outline About Your Instructor Allan Dewes    Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention. Email today to request a quotation

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

2014 GMP Training Recommendation - Root Cause for Deviation Investigations Workshop

Do your firm's   Planning for Training 2014!  2014 is just around the corner!  Do your firm's investigations conclude no assignable root cause, or Do your firm's investigations conclude the root cause was human error, or Do your investigations fail to identify product impact? If you answered "Yes" to one or more of these questions, then take a look at our Root Cause for Deviation Investigations workshop.

 

Featured Course Root Cause Analysis of Deviations: This course is more than idle chat. In this workshop, students apply root cause analysis tools to real in-plant deviations.   Tools addressed in this very popular workshop: 1. 5-Whys In-depth Map 2. Sequence of Events 3. Distinctions 4. Walk Through Analysis 5. Change Analysis 6. Control Barrier Analysis 7. Fishbone Diagrams and more!   If your firm is not satisfied with the quality of deviation investigations, then you need to look into our Root Cause Analysis of Deviations workshop!   Examine The Root Cause Analysis - Investigation of Deviations Outline      Allan Dewes, President.   About Your Instructor Allan Dewes Allan Dewes has worked on deviation investigations and trained others to do the same for over 30 years. Allan understands CGMP regulations, the FDA expectations, and how to make deviation training effective and fun.   Email today to request a quotation

 

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA Releases ICH Draft Guideline on Elemental Impurities

• FDA GMP Online Training - respected CGMP online training classes offered by SkillsPlus International Inc.

Updated February 14, 2021

Links broke in the original post.

People also ask about:

ICH HARMONISED GUIDELINE - GUIDELINE FOR ELEMENTAL IMPURITIES - 

Q3D(R1) - ICH Consensus Guideline (PDF)

- - -  original post follows below  - - -

US FDA Releases ICH Draft Guideline on Elemental Impurities - Outsourcing-Pharma.com:

"The guideline consists of three components: the evaluation of the toxicity data for potential elemental impurities, the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern, and development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE."

Follow this link to the guidance:  INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - DRAFT CONSENSUS GUIDELINE - GUIDELINE FOR ELEMENTAL IMPURITIES - Q3D (pdf)

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

GMP Training - Plan For Next Year - Buy "Qualstar Simulation"

• Buy now! FDA GMP online training courses offered by SkillsPlus International Inc.

Planning for Training 2014!

 2014 is just around the corner! 

1. Do CGMP documents contain many errors, or
2. Are change controls often side-stepped, or
3. Is the Quality Unit often side-stepped, or
4. Are procedures not always followed?
   
   If you answered "Yes" to one or more of these questions, then take a look at our 2014 Qualstar: A CGMP Training Simulation course. 

Featured Course (this course has been discontinued)

Qualstar - A CGMP Simulation: Designed to teach and to change the culture of companies in order to focus on quality and compliance. This competitive simulation is an eye-opener for participant and executive staff observers alike.

 

Issues addressed in this exciting simulation:
1. Documentation problems

2. Procedures not being followed

3. Change control not practiced

4. QA not consulted on deviations

 

If this describes some of your issues, then you need to experience Qualstar!

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

The Park Doctrine Resurrected | Managers, Corporation Can Be Prosecuted

FDA (Food & Drug Administration).  FDCA (Food, Drugs, & Cosmetics Act).

The Park Doctrine Resurrected | Marler Blog:

"In part, the focus of the Court’s opinion was whether “the manager of a corporation, as well as the corporation itself, may be prosecuted under the FDCA for the introduction of misbranded and adulterated articles into interstate commerce.” The Court concluded the answer to be yes."

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity

• Trusted FDA CGMP online training courses provided by SkillsPlus International Inc.

FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity:

"In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:

• to be used as an accessory to a regulated medical device; or
• to transform a mobile platform into a regulated medical device."

You might also be interested in:
Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB)

Return to SkillsPlus International Info Blog - Home

UDI System: The Final Regulation - Free FDA CDRH Video

• Respected FDA CGMP online training courses taught by SkillsPlus International Inc.

FDA | CDRH Learn | Unique Device Identification (UDI) System

"Unique Device Identification (UDI) System"

This is a collection of many presentations. Each of the presentations includes:

• the presentation
• printable slides, and
• a transcript

Return to SkillsPlus International Info Blog - Home

 

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Unique Device Identification (UDI) System - FDA Final Rule

Press Announcements > FDA finalizes new system to identify medical devices:

" . . . the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.

The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule."

Follow this link to view the Unique Device Identification System - Final Rule (PDF)

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Recommendations of FDASIA Health IT Workgroup Accepted - FDA Law Blog

• Recommended FDA CGMP online training courses offered by SkillsPlus Intl Inc.

FDA Law Blog: Recommendations of FDASIA Health IT Workgroup Accepted:

"The Food and Drug Administration Safety and Innovation Act (“FDASIA”), signed into law in July 2012, requires the Secretary of Health and Human Services (“HHS”) to "post a report - within 18 months (or by January 2014) - that contains a proposed strategy and recommendations on a risk-based regulatory framework pertaining to health IT, including mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."  FDASIA Section 618."

Return to SkillsPlus International Info Blog - Home
SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

ICH Increases Transparency - Publishes Its New Procedures Manual

ICH Looks to Increase Transparency of its Activities, Processes with New Procedures Manual:

"The International Conference on Harmonisation (ICH), a pharmaceutical regulatory harmonization body consisting of regulators from the US, EU and Japan, is publishing new documents intended to explain in full detail exactly what goes on within its regulatory black box."

For your reference:
ICH Procedures (PDF)

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Exemptee Training - HME DME - Meets CDPH HMDR Requirements

California HMDR Exemptee Training Certification Course  
Buy now - SkillsPlus International Inc.'s California Exemptee Training Course is accepted by the California Department of Public Health (Food & Drug Branch)

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. 

 

The HMDR Exemptee Plays A Vital Role:

• In order to dispense prescription (Rx) devices from your HMDR (Home Medical Device Retailer) facility you must employ either a licensed pharmacist, or a licensed HMDR Exemptee. For a description of HMDR Exemptee requirements, refer to the California Health and Safety Code, Division 104, Part 5, Section 111656.4 (a).

Background:

• A HMDR facility is defined as any area, place, or premises [other than a licensed pharmacy] in and from which prescription (Rx) devices, home medical devices, or home medical device services are stored, sold, fitted, or dispensed pursuant to a prescription at retail.
• A HMDR warehouse is owned by the HMDR facility and is a separate place where prescription (Rx) home medical devices are stored and transported to the firm's existing licensed HMDR facility (NOT direct to patients’ homes). There may not be any fitting, display, or sales at this facility. The warehouse is used for storage only.
• An individual may submit an application for an Exemptee license on their own behalf or a licensed HMDR operator may submit an Exemptee license application for a current employee for the purpose of dispensing prescription medical devices from that particular facility. In either case, the applicant must meet the required knowledge and training mandated by California Health and Safety Code, Division 104, Part 5, Section 111656.4 (a). This law requires one year of work experience in a facility where dangerous drugs and/or dangerous devices are dispensed, evidence of high school graduation or GED equivalent, and evidence that the applicant has completed a training course that addresses areas of HMDR knowledge and training.
• The HMDR Law can be found in the California Health and Safety Code, Sections 111656 through 111656.13 of the Sherman Food, Drug, and Cosmetic Law

Visit the HMDR Program Website for the most current information.

You might also be interested in:

• California Exemptee HMDR and DME Providers Certification Course - this course meets the "training course" requirement mentioned above
• The Exemptee Institute

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around