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."

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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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FDA - ANDA Stability Testing - New Draft Guidance Document

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

Updated October 31, 2022:

The FDA just released a new draft guidance document pertaining to stability testing of generic drug products and substances which calls for sponsors to rely on five existing standards promoted by the International Conference on Harmonisation (ICH).

Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products

The following existing ICH guidances address stability for new drug substances and products, and are referred to in the FDA guidance:

1.     Q1A (R2) Stability Testing of New Drug Substances and Products.
2.     Q1B Photostability Testing of New Drug Substances and Products.
3.     Q1C Stability Testing for New Dosage Forms.
4.     Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products.
5.     Q1E Evaluation of Stability Data 

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

Updated March 14, 2021

Announcing:

GMP Trainer Awareness, Certification, and Master Trainer Certification Course

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

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. 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, Certification, and Master Trainer Course - a train-the-trainer course for FDA QSR cGMP trainers

 - -   original post follows below  - -

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

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  ---

Don't delay!

Our annual public seminar is nearly sold out.

Register now for this very popular in-person course:

CGMP/QSR Trainer Certification Program - Public Seminar by SkillsPlus International Inc.

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


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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

Highly Recommended QSR & GMP Trainer Certification

Updated June 12, 2025

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

Questions? Call us: (415) 948-5220

- - -  original post follows below  - - -

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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FDA 483s Can Form Basis of Class Action Lawsuit

• Trusted FDA cGMP online training programs and courses offered by SkillsPlus Intl Inc.

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."

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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.

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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 GMP online courses, and programs.

Year after year, SkillsPlus QSR & GMP training and trainers are described as . . .

• the best
• respected
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• recommended
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Complete Exemptee & Designated Representative Training Before School Ends & Summer Begins

Complete Exemptee & Designated Representative Training Before School Ends & Summer Begins | Designated Representative and Exemptee:

"School's almost out for Summer!

Don't let your Exemptee training or Designated Representative training hang over your head going into Summer.

Just get it done now, and enjoy!"

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CA HMDR Exemptee online CBT training certification by SkillsPlus Intl Inc.

CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.

SkillsPlus Intl Info Blog
SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website

QSR and GMP Training Online - Classes by SkillsPlus Intl Inc

Online training gets a bad rap, because there's so much bad stuff out there. There's better training out there!

SkillsPlus International Inc. knows that you expect: 

• online classes that can be taken when you want, 24 x 7
• online classes that avoid travel and hotel costs associated with live training

Check out SkillsPlus International Inc. online training.

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