Monday, December 10, 2012

GMP Posters & QSR Posters - Buy The Entire Collection!

Take advantage of a simple way to reinforce your compliance messages, by putting up posters.

As many trainers and managers know, creating excitement about the next training topic or  keeping the compliance message alive after training is always a challenge.

This product line of large posters, created by the well-known San Francisco artist, Francis Redman, attracts attention and reinforces key compliance messages.
  • Buy individual posters, by image or by compliance message
  • Buy all the posters on CD
Individual Posters
You can choose individual posters, by selecting an image and then selecting a compliance message.
QSR & GMP Posters by SkillsPlus International Inc.

All The Posters on CD
Better yet, purchase all the posters on CD.  This way you'll get 12 different posters and 56 different slogans to choose from.
QSR & GMP Posters on CD - the Catalog - SkillsPlus Intl Inc.
Purchase QSR & GMP Poster on CD - via the SkillsPlus Intl Inc secure site

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Tuesday, December 4, 2012

2013 Plan For FDA CDRH Guidance Documents

The CDRH is considering developing a variety of guidance documents in fiscal year 2013. Specific topics and status as final and draft guidance document, are provided in the two lists:


Prioritized medical device guidance documents that the Agency intends to publish in FY 2013 ("A-list")


Final Guidance Topics
  • Refuse to Accept (RTA) Policy for 510(k) Submissions
  • Acceptance and Filing Review for Premarket Approval Applications
  • Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
  • In Vitro Companion Diagnostic Devices
  • Design Considerations for Pivotal Clinical Investigations for Medical Devices
  • De Novo Classification Process (Evaluation of Automatic Class III Designation)
  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
  • CDRH Appeals Processes
  • Medical Device Classification Product Codes
  • The Pre-Submission Program and Meetings with FDA Staff
  • Mobile Medical Applications
  • eCopy
  • Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

Draft Guidance Topics
  • Distinguishing and Reporting Medical Device Recalls from Product Enhancements
  • Types of Communication During the Review of Medical Device Submissions
  • FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
  • eCopy
  • Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2013 ("B-list")


Final Guidance Topics
  • Finalizing existing draft guidance documents.

Draft Guidance Topics
  • Benefit-Risk Determinations in Premarket Notifications (510(k)s)
  • Direct to Consumer (DTC) Genetic Testing: IVDs
  • Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
  • Custom Devices


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Thursday, November 29, 2012

2013 GMP Training - It's Time To Start Planning

It's time to start planning your 2013 QSR and cGMP training, and consider engaging SkillsPlus International Inc. as your external trainer.
  1. Tackle 2013 now! Coordinating future training is involved, so get ahead of the new year before it arrives. Waiting to start planning conversations in the new year only perpetuates delays, and contributes to pushing off training to the last minute.  
  2. Send the right message!  By delaying early planning for 2013 training, there's a risk of sending unintended and unspoken messages that training isn't very important.
  3. Deliver the best training!  Brainstorm your training needs with the leaders in GXP compliance training. Sometimes discussing things with, or bringing in external trainers can ratchet up the quality of training that students will experience. SkillsPlus International Inc. is a leader in compliance training, having trained thousands of students, over more than 20 years. Past students rave about the engagement and interactivity experienced in SkillsPlus courses.
Partner now with SkillsPlus International Inc. for your 2013 QSR & GMP training needs, to ensure that your Master Training Plan delivers timely quality training programs throughout the coming year. Simply visit our website to get started:

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GHTF Archives Can Be Found On The IMDRF Website

SkillsPlus International Inc.: Overview | LinkedIn:

"The Global Harmonization Task Force (GHTF), the global medical device harmonization body no longer exists. The GHTF has been permanently replaced by the IMDRF (International Medical Device Regulators Forum), a successor organization comprised of officials from regulatory agencies around the world. The GHTF website no longer exists. Fortunately, the GHTF Archives are now housed on the IMDRF website. These archives (follow the hyperlink below) should be considered historic information, no longer current, and therefore, should not be acted upon.

http://www.imdrf.org/ghtf/ghtf-archives.asp "

'via Blog this'

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Thursday, November 22, 2012

FDA Adopts ICH Q11 (Development & Manufacture of Drug Substances)

The Food and Drug Administration (FDA) posted a guidance entitled “Q11 Development and Manufacture of Drug Substances.” The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities). The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.

Related Links:
FDA Guidance for Industry - Q11 Development and Manufacture of Drug Substances (PDF)
ICH Q11 - Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities)  (this links navigates to a page containing Q11-related documents)

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Tuesday, November 13, 2012

Why GMP Training Does Seem To Work

Why GMP Training Does Seem To Work
Free Training Tips from SkillsPlus International Inc. - by Allan Dewes

GMP training doesn’t always seem to make a difference. We send our employees to class, yet they never change their compliance practices. Perhaps our employees are doing what we unintentionally encourage them to do – even though it’s not what we really want. There can be several reasons for this:
  1. poorly designed or delivered training, 
  2. a disconnect between what is taught in class and what is professed on the line and in meetings, and 
  3. a lack of an organizational infrastructure to support and encourage GMP compliance 

Poorly Designed or Delivered Training 
A good design doesn’t have to look good, but it helps. A good design follows a logical flow and links concepts together in a logical flow that leads to a logical conclusion of what is the appropriate behavior. Employees need to know what the gaps are between what is currently practiced, and what is expected. However, even the best design in the world may be totally ineffective if the class is asleep. For instance, employees that have been working for eight hours before a class, are often made to sit in a dimly lit conference room, listening to the instructor drone on for the 93rd time about using black ink in documentation. GMP training delivery must be alive – kick it up! Remember, as trainers we are competing with the jazz of Nintendo, Wii, iPad, smartphones, and the Internet. Activities that reinforce learning objectives are a great way to jazz up training for even the most reserved trainers.

Disconnect Between Preaching & Practice 
A telltale sign of a disconnect between what is preached in the organization and what is practiced can be quickly assessed in the plant floor rumblings. Have you ever heard someone say, "I know what ‘they’ told me in class, but my supervisor wants me to get the product out the door." Perhaps you recently heard, "Those trainers don’t know how the job is really done around here." Or maybe you heard, "Tell management about these rules, they need to hear it." These comments are usually countered with, "Where did they ever get those ideas from? Of course I want GMP compliance!" However, somewhere in the employee’s work life they heard a message different than the one you intended. For example, the speed limit on many highways is stated as 65 mph (your area may be different). The message appears to be clear, but many drivers exceed the speed limit. So, what is the message many drivers hear – it’s okay to drive 70 mph. Is that second message intentional or not? Is it spoken or unspoken? Do we send the right messages about our compliance intentions?

Lack of Organizational GMP Compliance Support and Encouragement 
If behavior doesn’t change, so say behaviorists, then the environment hasn’t encouraged or supported the desired change. Let’s continue the analogy of the driver speeding on the highway. There are obviously little or no consequences for exceeding the speed limit by perhaps 5-7 mph. (Please note: I’m not giving drivers permission to exceed the speed limit, nor am I liable for those who do get tickets, I’m merely reporting an observation.) What would happen if we were all (100% of us) given speeding tickets for even 1 mph over the limit? Behavior would change, or some of us would go broke. So how are we doing in the area of GMP compliance in our plants? I see many QA auditors correcting batch records with little or no feedback to the person who made the mistake for the 93rd time. I see people responsible for SOP updates that can’t get comments back because, "We were too busy." I see trainers with empty classes because we had product to get out the door.

The Recipe For A Successful GMP Compliance Initiative Includes: 
  1. Strong training program design 
  2. Delivery with the energy and jazz of current entertainment media 
  3. Rich and accurate content 
  4. Consistent messages with the practices demonstrated by our behavior and decisions 
  5. Organizational systems that encourage and support GMP compliance! 
  6. Have SkillsPlus Intl Inc. deliver your next training. Call:  (415) 487-3500 or (954) 873-5422 

About the Author 
Allan Dewes is the President and Founder of SkillsPlus International Inc. Allan is a master trainer, possessing over 25 years experience in identifying training needs and designing QSR & cGMP training programs. He is known for designing user friendly courses and conducting highly interactive classes that teach concepts easily and playfully.

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Monday, November 12, 2012

Regulators, Industry Discuss Potential Impact of IMDRF

The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body.

Regulators, Industry Discuss Potential Impact of IMDRF > RAPS > News - Article View:

"Unlike GHTF, which was a blend of agency regulators and industry representatives, IMDRF relegates industry to a consultation role while keeping regulators in the drivers' seat. "After 20 years, time for a change," said Minor

This desire for accelerated change is written into the agency's mission, observed Trautman, speaking to the session by video link after an East Coast hurricane prevented her from attending in person. "The mission of the IMDRF is to strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety," she relayed, quoting its mission statement."

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturers - A Training Course - Teaches the FDA QSR Regulations

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Sunday, November 11, 2012

Consider On-Site Training - Popular GMP Classes and QSR Courses

Comprehensive master training plans often take advantage of a 'blended' training approach . That is, a mixture of multiple training modalities, including online training and live instructor-led classes.

As 2013 approaches, you might want to consider and/or justify bringing in SkillsPlus Intl Inc. to deliver your on-site in-person training classes.


Consider these features and benefits of live, on-site, in-person training.

Convenient, Flexible, & Interactive 
  • You get to pick the date, time, & location – adjust for shifts, or number of days that works best for your employees; select your facility, plant, training center, or other desired location 
  • In-person training engages students – with the right instructor on-site training encourages interaction according to class size and level of training, ensures consistent messages, and fosters team building 
Content That Fits Your Needs 
  • Your training needs are addressed - training content & activities are adjusted, based on students’ prerequisite & current skill levels, and the organization’s specific needs, objectives, issues, and challenges. Tailoring the content ensures that training is unique & relevant. 
  • Confidential issues can be covered - Training on-site means you can candidly discuss your organization's unique challenges and opportunities. Sensitive company information can be shared by participants and used as concrete examples during interactive and workshop sessions in complete confidence. 
Great Value 
  • Avoid having to leave the building - Without ever leaving the building, staff can gain new skills, boost their confidence, and improve their productivity. Since on-site training takes place at client’s premises, there is no travel, no time away from the plant, and no unrelated expenses that are often associated with public courses (e.g. travel, hotel, subsistence, etc.). 
  • You get live in-person expert instruction! The best on-site teachers are skilled facilitators and/or consultants. With the right instructor, you get the added advantage of getting expert advice alongside the training.
You won't be disappointed by selecting SkillsPlus Intl Inc. to deliver your on-site training. Our past students say that they love our interactive style, learn a lot that they can put into immediate use, and recommend us to their industry friends.


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Saturday, November 10, 2012

November is Natl Home Care and Hospice Month

California Association for Health Services at Home:

"November is National Home Care & Hospice Month

Celebrate the Heroes of Home Care
Each November, the California Association for Health Services at Home (CAHSAH) along with the entire home care industry throughout the country celebrates National Home Care and Hospice Month to honor care giving heroes who make a remarkable difference in the lives of patients and the families they serve. It is an important opportunity to recognize the health care administrators, nurses, clinicians, therapists, aides, homemakers, chore workers, companions and other home care professionals who assist some of our most frail citizens and help them to remain at home and in the community.
“During National Home Care and Hospice month, we take time to honor the thousands of individuals in home care and hospice who, on a daily basis, provide remarkable care in people’s homes. Thank you for all that you do.” - - - CAHSAH President Joe Hafkenschiel"
'via Blog this'

You might also be interested in:
CA HMDR Exemptee online training certification - for HME DME retailers wholesalers
The Designated Representative and Exemptee Blog

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CA Designated Representative internet-based training certification by SkillsPlus Intl Inc.
FL Designated Representative web-based exam preparation by SkillsPlus Intl Inc.

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Sunday, October 28, 2012

CA HMDR Exemptee Training - The Best Course Around

SkillsPlus International Inc. is a long running provider of training to home medical device retailers (HMDR) and durable medical equipment (DME) wholesalers.

Since 2002 SkillsPlus has provided up-to-date training for their clients. This website page, California Exemptee HMDR and DME Providers Certification Course,  provides information specific to the California Exemptee certification course. For those seeking two certifications, this course also meets the requirements for the Board of Pharmacy California Designated Representative.

California requires home medical device retailers to retain an on-site Exemptee to conduct their business. The Exemptee must be physically present during all hours of operation. This course is recommended by, and meets the training requirements of, the CA Department of Public Health, and covers:
  • California Code of Regulations 
  • Business and Professions Code 
  • Prescription Drug Laws 
  • Controlled Substances 
  • USP Storage Conditions 
  • Health and Safety Code 
Prospective Exemptees can meet the training requirement by taking SkillsPlus Intl Inc.'s web-based, self-study class (that includes a final exam) for training certification. The class is fast, to the point, and has helped thousands of potential California Exemptees get licensed.

To get a flavor of the web-based training, watch this snippet:


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CA HMDR Exemptee online training certification - The best course that's available!
CA Designated Representative online training certification - Highly recommended!

FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.
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Wednesday, October 17, 2012

What Is A Pharmacy Designated Representative?

If you're new to the pharmacy world of the Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:
A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.
There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:
Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.
The trick then becomes finding a way to fulfill the training program requirement.

SkillsPlus International Inc. offers designated representative training for California and Florida, so you might be interested in:


The Designated Representative and Exemptee Blog

CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
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Tuesday, October 16, 2012

Medical device firms growing in South Florida

Medical device firms growing in South Florida - South Florida Sun-Sentinel.com:

"Florida is the fastest-growing state in creating new biotech companies and ranks second in medical device firms, according to global research firm Battelle. The southeastern region of the state, which includes Broward and Palm Beach counties, has the largest number of bioscience companies in Florida, as tracked by a University of Florida life science database.

Venture capitalists and investors are taking notice, listening to pitches at last week's BioFlorida conference from local firms seeking partners and funding. But there are many hurdles to success.

For medical devices, those challenges include ongoing financing of research, completing successful clinical trials, paying for expensive regulatory approvals, and ultimately getting hospitals and doctors to use the products."

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturers - Onsite Training This course teaches employees about the essential elements of the FDA's QSR regulations for starting work in the medical device industry

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SkillsPlus Intl Inc. website - GMP & QSR Compliance Training - Popular and Highly Regarded
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Wednesday, October 10, 2012

PDA Biennial Training Conf - Oct 2012 - A success!

Just got back from a great PDA meeting in Bethesda: the PDA Biennial Training Conference - From training to learning - Improving performance in a regulated environment.

I took advantage of the opportunity to go on a tour of the PDA offices and TRI (training and research institute).  Very impressive learning labs and classroom facility.

It was great to re-connect with our industry friends. Needless to say, there was very palpable interest in e-Learning,

For those interested in finding our cGMP and QSR e-Learning courseware, I've included the following links to collections of what SkillsPlus Intl Inc. has to offer:

e-Learning Courses offered by SkillsPlus International Inc.
e-Learning Courses offered by SkillsPlus International Inc. - Course Descriptions (PDF)

For more information about the PDA (Parenteral Drug Association)

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Monday, October 1, 2012

QSR and cGMP Trainer Certification - 2012 Public Seminar - Registration Ends Soon

SkillsPlus offers the best training around!

Updated May 6, 2014:


Did you miss our public seminar? We also offer this program as an on-site course conducted at your location. Give us a call: (415) 487-3500, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm

---

Next week is the registration deadline for the cGMP & QSR Trainer Certification Public Seminar in San Francisco (October 22-26, 2012).

For more information:
cGMP/QSR Trainer Certification Program - A public seminar by SkillsPlus International Inc.:
This is a five-day class in which participants experience many different ways to teach CGMPs and QSRs. Students get to see and learn what the instructor is thinking about during sessions, so that the training approaches can be applied back at the student's company. Students make two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

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Monday, September 10, 2012

cGMP & QSR Trainer Certification - 2012 Public Seminar - Seats Nearly Gone

Updated May 6, 2014:


Did you miss our public seminar? We also offer this program as an on-site course conducted at your location. Give us a call: (415) 487-3500, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm

---

Don't delay!

Our annual public seminar is nearly sold out.

Register now for this very popular in-person course:


This public seminar will be held October 22-26, 2012 in beautiful San Francisco.


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Monday, July 2, 2012

Highly Recommended QSR & GMP Trainer Certification

Updated May 6, 2014:


Did you miss our public seminar? We also offer this program as an on-site course conducted at your location. Give us a call: (415) 487-3500, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm

---
GMP & QSR Trainer Certification Program
(offered as a public seminar Oct 22-26, 2012 in San Francisco, CA)

Refine your skills and become the best QSR or GMP trainer that you can be!

Learn about things to do in San Francisco:  San Francisco Travel for Visitors

This is a five-day class where participants experience many different ways to teach CGMPs and QSRs. Then 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.

For more details, check-out the brochure: CGMP/QSR Trainer Certification Program (PDF)

To register for the class: Register for the CGMP/QSR Trainer Certification Program

Public Seminar Schedule and Course Description:  SkillPlus International Inc.

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Monday, June 11, 2012

FDA 483s Can Form Basis of Class Action Lawsuit

In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the U.S. Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs.

Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder lawsuit as the result of an FDA inspection report. This is an important event, and here's why . . .

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit - RAPS - News - Article View:

"On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading FDA about manufacturing problems at a facility and later shutting down the facility’s manufacturing operations."

'via Blog this'

What's important to note is that this decision is a marked reversal from existing precedence, which has found Form 483 reports to be immaterial to federal securities law.

You might also be interested in these highly recommended courses:


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Tuesday, May 29, 2012

The Best GMP Training - Look No Further!

Look no further!

SkillsPlus International Inc. students, trainees, and clients all agree, we're the best.

Learn more about SkillsPlus International Inc. industry leading QSR and GMP onsite & online courses, and products & services.

Year after year, SkillsPlus QSR & GMP training and trainers are described as . . .
  • the best
  • respected
  • popular
  • recommended
  • terrific
  • tops
  • excellent
  • superior
  • great
  • the greatest
  • reliable
  • top-rated, top rated
  • top-ranked, top ranked
  • expert
  • top quality
  • superb 
  • unequaled
  • unparalleled
  • unrivaled
  • unsurpassed
  • cream of the crop
  • informative
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Monday, May 7, 2012

QSR and GMP Training Online - Classes by SkillsPlus Intl Inc

Allan Dewes - President
SkillsPlus Intl Inc.
Online training gets a bad rap, because there's so much bad stuff out there. Don't settle for simple page turners, or slides of boring content.  ... there's better training out there!

Our SkillsPlus International Inc. online training offerings are:
  • engaging
  • energizing
  • exciting
SkillsPlus knows that you expect something social, movie interactive, and NOT BORING!
  • online classes can be taken when you want, 24 x 7
  • online classes avoid travel and hotel costs associated with live training
  • SkillsPlus Intl Inc online classes are offered in various formats and packages to suit your needs

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Monday, April 23, 2012

GMP posters! QSR posters! Posters Posters Posters!

As many trainers and managers know, creating excitement about the next training topic or  keeping the compliance message alive after training is always a challenge.

This line of large posters, created by the well-known San Francisco artist Francis Redman, attracts attention and reinforces key compliance messages.

This product line has been discontinued

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Wednesday, April 18, 2012

On-Site Class Catalog - QSR FDA GMP Training by SkillsPlus Intl Inc.

If  you've got training needs, we've got the onsite courses and classes for you!
  1. Our live classes span QSR and cGMPs, and more!
  2. We're training experts with experience!
  3. Avoid boring courses. Students love our exciting, energizing, and engaging classes!
Checkout our catalog of  live, on-site, in-house classes, delivered at the location of your choice:


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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
SkillsPlus Intl Inc. - Sign-up for our announcements via Constant Contact
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