FDA names its first medical device cybersecurity director - Fierce Biotech

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

According to the article:

"The FDA has appointed its first medical device cybersecurity chief to help guide the agency’s regulatory strategies as more devices become interconnected—and potentially more vulnerable to digital attacks and breaches.

Kevin Fu, an associate professor and research fellow at the University of Michigan, was named to the post. He will serve a one-year term as an expert-in-residence at the agency’s Center for Devices and Radiological Health (CDRH) as well as at its nascent Digital Health Center of Excellence, which launched last fall."

Read the full source article:  FDA names its first medical device cybersecurity director - Fierce Biotech

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

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Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

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

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

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.

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Free GMP Training Tips
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Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA plans to use ISO 13485 for medical devices regulation - ISO.org

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

Read the full news article: FDA plans to use ISO 13485 for medical devices regulation - ISO.org

"The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally. 

ISO/TC 210 warmly welcomes the FDA’s planned adoption. This ISO technical committee, responsible for the quality management and corresponding general aspects for medical devices, is run by ANSI, ISO’s member in the United States."

Learn more about the proposed rule:

• RIN: 0910-AH99 - Title: Harmonizing and Modernizing Regulation of Medical Device Quality Systems
• Follow the status of the proposed rule on FDA.org (enter "0910-AH99" in the Search box)

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Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews

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

Read the full article: FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews:

"The guidance seeks to articulate what's new and different about SaMD (a category which would include mobile medical apps) and provide a stratified guidance on how to regulate different kinds of software and what kind of evidence is needed for each regulatory category. The guidance stratifies devices on two axes: whether the device informs care, drives care, or treats/diagnoses and whether the condition in question is non-serious, serious, or critical. So software that treats or diagnoses a critical condition is in the highest risk category, while software that informs care about a non-serious condition is in the lowest."

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View the draft guidance:
Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability

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

 

Technical Considerations for Additive Manufactured Devices - FDA.gov

Guidance Documents (Medical Devices and Radiation-Emitting Products) > Recent Draft Medical Device Guidance Documents - FDA.gov:

"Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff" (PDF)

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FDA outlines cybersecurity recommendations for medical device manufacturers

Read the full article:  Press Announcements > FDA outlines cybersecurity recommendations for medical device manufacturers - FDA.gov:

"The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market. The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential cyber threats."

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Read the FDA draft guidance:
Postmarket Management of Cybersecurity in Medical Devices (PDF)

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Deviation Investigation Report Writing - GMP Training
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The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov

Read the full press release:  Press Announcements > The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov:

"To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software."

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Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post

Updated February 26, 2021

Links in the original post broke.

People also ask about:

Virulent Chinese hacking group mows through U.S. health industries - SCNOW

- - -  original post follows below  - - -

Read the full article: Virulent Chinese Hacking Group Mows Through U.S. Medtech, Pharma - Washington Post Business Page, Business News:

"The breaches have forced companies to boost efforts to protect their computer banks. On average, health-care companies spent $2.2 million on information security in 2013, a more than 20 percent increase from the prior year, according to a PwC, CIO and CSO magazine survey.

“I recently met with three CEOs in health care and in most cases they had come to the conclusion that they definitely did under-invest,” said Mick Coady, a partner at PwC’s health information privacy & security group. “Health care is at least a decade, if not more, behind.”"

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Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus:

"In Brief, What's This Issue About?

In the US, the Food and Drug Administration (FDA) regulates many products to ensure that they are safe and effective, including medical devices such as wheelchairs and pacemakers. However, the definition of "medical device" also includes software, and in recent years FDA has moved to regulate software found on mobile phones, what most people refer to as "mobile apps."

Critics have raised the point that strict regulation of medical mobile apps could stifle innovation in the sector, while others have pointed to spurious or faulty apps to make the point that regulation is sorely needed."

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GMP Trainers - Why You Should Get Training

GMP Training Certification Course: GMP Trainer Awareness, Certification, and Master Trainer Course - Online Self-Study

• It's important to learn the most effective ways to train your employees
• Never stop learning! Train & be trained as often as possible
• Your training toolbox should have a ton of things in it. 

FDA GMP Trainer Certification Course

"The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires." - William Arthur Ward

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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.

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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). 

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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

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

How To Become A Better GMP Trainer

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.

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Trainers must be skilled!

• They must be expert course designers and facilitators
• They must pay attention to the experiential learning process
• They must keep students involved, engaged, and energized

It’s a given that GMP & QSR trainers must have mastery over the regulations that they are teaching. Mastering applicable laws, regulations, directives, standards, guidance, and compendia for manufacturing biologics, drugs, dietary supplements, and medical devices is essential for raising your company’s employees and management team compliance competency.

GMP & QSR trainers must also be able to help others expand their knowledge of relevant regulatory requirements, and to help others apply that knowledge in the workplace.

What does that mean?

It means that trainers must have the skills needed to teach others. We often find that trainers, program designers, training supervisors, training managers, and others who conduct GMP or QSR training in the pharmaceutical, biotech, medical device or dietary supplement industries need help in developing their training skills.

Expert GMP & QSR trainers:

1. Focus on experiential learning processes
2. Teach in a facilitation and learning style that’s appropriate to particular regulatory topics
3. Design and facilitate learning activities
4. Facilitate meaningful discussions, and create safe environments through the debrief process
5. Model different teaching strategies
6. Tell compelling case stories
7. Keep students involved, engaged, and energized

 

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In-Plant On-Site GMP Training & QSR Training Courses

Updated March 10, 2021

Given the COVID-19 pandemic, people are also searching for CGMP online training courses:

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

- - -

We offer onsite, in-plant GMP training & QSR training courses.

If you've got training needs, we've got the 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! 

Learn more about our training offerings that can be delivered at the location of your choice:
Live, in-plant, on-site, GMP training & QSR training courses taught by SkillsPlus Intl Inc.

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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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Essentials for Medical Device Manufacturers - QSR training class

Updated June 5, 2025

This specific course is no longer offered.

You might also be interested in these online training programs:

https://skillsplusinc.com/cbpresent.htm

---  the original post follows below  ---

In this original or refresher training, experience fun learning the regulations.

Essentials for Medical Device Manufacturers by SkillsPlus International Inc. is an instructor-led training class, taught on-site in-house at client plant locations.  This is useful as a new employee basics course, and can be used as a refresher course.

Purpose:
This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.

Objectives:
Upon class completion, students will be able to . . .
1. State the historical development of QSR regulations.
2. Explain the role and function of standard operating procedures.
3. Describe the personal role for contamination control.
4. Identify the sources of contamination.
5. List the common QSR documentation practices.
6. Explain material controls.
7. State the common practices of production and process controls.
8. Explain the importance of an adequate, appropriate, and sufficient building design.
9. State the requirements of equipment design and construction.
10. List the requirements for building, and equipment cleaning and maintenance.
11. Explain the role of the quality management system.
12. Explain the role of the laboratory.

Topics:

• Heard on the street
• Past, present, and future
• Legal issues
• Personnel responsibilities
• Standard operating procedures
• Contamination
• Personal hygiene
• Cleaning
• Documentation
• Materials
• Process control
• Buildings and facilities
• Equipment
• Validation
• Calibration
• Laboratory
• Quality management system

For more information about this class:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc

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Live Onsite QSR Training - Essentials for Medical Device Manufacturers

Here's one of our popular onsite QSR training classes:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc.

This live class can be taught at the client site location of your choice.

This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.

Upon completion of this class, students will be able to:

1. State the historical development of QSR regulations. 
2. Explain the role and function of standard operating procedures. 
3. Describe the personal role for contamination control. 
4. Identify the sources of contamination. 
5. List the common QSR documentation practices. 
6. Explain material controls. 
7. State the common practices of production and process controls. 
8. Explain the importance of an adequate, appropriate, and sufficient building design. 
9. State the requirements of equipment design and construction. 
10. List the requirements for building, and equipment cleaning and maintenance. 
11. Explain the role of the quality management system. 
12. Explain the role of the laboratory.

Learn more about this class:
Essentials for Medical Device Manufacturers - On-site training by SkillsPlus International Inc.

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

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Online GMP Training - 21 CFR 820: Essential Elements

Updated October 28, 2018

The original post didn't age very well.

You might be interested in the current selection of SkillsPlus International Inc's FDA QSR cGMP training courses and workshops

- - -  original post follows below  - - -

Take this online CBT (computer based training) if you need to review the 21 CFR 820 regulations from the perspective of being inside a medical device manufacturing facility. Learn the rules affecting medical device manufacturing, while getting a glimpse of medical device production techniques.

21 CFR 820: Essential Elements on the Computer-Based Training page by SkillsPlus International Inc.

This class is appropriate for all employees of medical device manufacturing organizations. Upon the completion of the class, employees will be able to summarize the 15 subparts.

Online computer-based training (CBT) is the way to complete required training at minimal cost.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts

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