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Quality Connection Courses – Safelink Consulting

YOUR OWN VIDEO LIBRARY WITH 24/7 AROUND THE CLOCK ACCESS

 to access the courses shown below. Take a quiz and test your knowledge for continuing education credit. If you pass, then you will be presented with a Certificate of Completion.

60 Minute Time Limit

Most course videos are approximately one hour in length. Once you begin the test portion below the video, the timer will start with 60 minutes. This gives you ample time to complete the test, in case you need to save and resume at a later time, or retake the test if you do not pass the first time. For example, if you begin the test and then save it after 10 minutes to resume tomorrow; then you will have 50 total minutes remaining to complete the test when you return.

Courses provide the following continuing education credit. See individual course description for specific credit provided:
  • NBC Regulatory Standards credit
  • Florida Office of Dental Laboratories Prevention of Medical Errors or General Credit
  • AGD Approved PACE Program Provider FAGD/MAGD Credit
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This video will help guide you step-by-step through taking your courses online.

How to Navigate Public Info on FDA’s Website

Don’t wait until an FDA inquiry to meet registration and clearance requirements. Knowing how to navigate and utilize FDA’s website will make for a less stressful experience when facing an FDA investigation. This information will help support your FDA compliance program, including quality system and good manufacturing practices requirements.

In this course learn how to:

  • use these resources and tools to determine if your products are regulated by FDA,
  • determine which regulations affect your specific business activity,
  • register your establishment if FDA registration is required,
  • renew your establishment’s FDA registration, and
  • ensure accuracy of registration.
  • This course will benefit:
  • medical device manufacturers, including dental custom implant abutments, and
  • food manufacturers, including beverage compliance for breweries, wineries and distilleries.
Introduction Video

3 Ways Your Product Offerings Can Trigger FDA’s Attention

Is the information on your website triggering FDA’s attention to your business? Branding, using proprietary names, and marketing custom devices affect how your business model is portrayed to FDA. From importation of devices to manufacture of devices that require FDA 510(k) clearance, learn what you could expect from FDA and the impact it could have on your business. For devices requiring a FDA 510(k) clearance, the presenters discuss how to get devices on the market and how to manage subsequent changes. This is a pre-recorded webinar. Take this course to learn more about: • FDA regulated activities for medical devices, • how registration and listing errors can increase FDA scrutiny, • how public media marketing exposes a business activity to FDA, and • how FDA’s medical device premarket notification (510k) process works. This course will benefit: • medical device manufacturers, including dental custom implant abutments

1 Hour CE credit provided for: AGD PACE Program credit, NBC Regulatory Standards, CE Broker – FL Board of Dentistry credit, FL Office of Dental Laboratories General credit.
Introduction Video

Using Your Lab Quality System to Reduce External and Internal Remakes

The effectiveness of your dental lab Quality System can be measured in many ways, but the primary factor is how you reduce customer complaints. Documenting them is required, however, how you follow through with corrective action is the determining factor for reducing the dental lab cost of remakes. There are national average remake numbers available through various sources, but if you use those numbers as a comparison of your remakes how do you know you’re comparing apples to apples? This course will take you through methods that will provide you with a true picture of how to handle customer complaints, and how to use CAPA, as well as cover the Medical Device Reporting Requirements for documenting complaints against Class II devices. This is a pre-recorded webinar. Please disregard any reference to submitting Course # in the presentation to request continuing education credit.

1 Hour CE credit provided for: AGD PACE Program credit, NBC Regulatory Standards, CE Broker – FL Board of Dentistry credit, FL Office of Dental Laboratories General credit.
Introduction Video

Improving Your Quality Output

It’s all about effective problem solving techniques. One of the components of a Quality System is the documentation of complaints and nonconforming product. You may have methods in place for this type of documentation, but how are you using that documentation to solve problems? Non-conformances could be remakes, complaints from your dental clients, and internal reworks. The method you use to get to the root of your lab’s recurring problems can make the difference in your profitability. In this webinar you’ll learn how to identify, evaluate, and implement optimum solutions while complying with FDA’s corrective action process. This is a pre-recorded webinar. Please disregard the reference to submitting Course # in the presentation to request continuing education credit.

1 Hour CE credit provided for: NBC Regulatory Standards and FL Office of Dental Laboratories Prevention of Medical Errors or General credit.
Introduction Video

The Basics of FDA’s Title 21 Course

This course provides general knowledge of FDA requirements for the dental laboratory. FDA requires that all dental labs implement a Quality Management System. This course will present an overview of the law, what you must do to comply, who must register with FDA, what QS/GMP’s are and how implementing them will not only make your lab compliant with the law, but also more productive and profitable. This is a pre-recorded webinar. Please disregard the reference to submitting Course # in the presentation to request continuing education credit.

1 Hour CE credit provided for: NBC Regulatory Standards and FL Office of Dental Laboratories Prevention of Medical Errors or General credit.
Introduction Video

FDA – Auditing Series Part 1 – Basics of Internal Auditing

This course series is intended for those individuals who are responsible for auditing the Quality System whether it’s DAMAS or FDA’s Quality System Regulation. A general overview of the Quality System will be addressed; therefore, it also provides a basic knowledge of the DAMAS specifications and the FDA’s Quality System/Good Manufacturing Practices. This information applies to auditing any type of quality system. The course will cover purpose and scope of an audit; formation of the audit team; types of audits; requirements under DAMAS, ISO, and FDA audits; and components of the audit. This is a pre-recorded webinar. Please disregard the reference made to handouts and the NBC Course code in the presentation. There are no handouts provided for this online course.

1 Hour CE credit provided for: NBC Regulatory Standards and FL Office of Dental Laboratories Prevention of Medical Errors or General credit.
Introduction Video

FDA – Auditing Series Part 2 – Components of the Audit Process

This course is intended for those individuals who are responsible for performing the audit or participating in components of the audit. It will also be helpful for department managers to understand what the auditors are looking for. The topics covered in this course are management system, conformity policy, general-legal, documented review/receiving, patient contact materials – purchasing, process controls, and training, plus equipment maintenance/calibration, cleanliness, documented review of final product, packaging/labeling, control of records, and complaints/CAPA. This is a pre-recorded webinar. Please disregard the reference made to handouts and the NBC Course code in the presentation. There are no handouts provided for this online course.

1 Hour CE credit provided for: NBC Regulatory Standards and FL Office of Dental Laboratories Prevention of Medical Errors or General credit.
Introduction Video

FDA – Auditing Series Part 3 – Documenting the Audit

This course is intended for individuals who are responsible for performing the audit and then either participating in or writing up the Audit Report. This information applies to auditing any type of quality system. The course will cover setting and documenting the audit scheme; logistics of the audit with the audit team; format of the audit investigation; format of the audit report; response to nonconformances in the audit report; and agenda for management review meeting. This is a pre-recorded webinar. Please disregard the reference to submitting Course # in the presentation to request continuing education credit.

1 Hour CE credit provided for: NBC Regulatory Standards and FL Office of Dental Laboratories Prevention of Medical Errors or General credit.
Introduction Video

Florida Rules and Laws of Dental Labs & Technicians

This course will address which laws and rules are required for dental labs and dental technicians located in the state of Florida. This is a pre-recorded webinar. Please disregard the reference to submitting Course # in the presentation to request continuing education credit. For FL Office of Dental Laboratories licensing credit, be sure to read the ID Field Requirements in yellow box and the Continuing Education Credit in blue box for instructions on submitting credit.

1 Hour CE credit provided for: NBC Regulatory Standards and FL Office of Dental Laboratories Laws and Rules of DL’s & Dtl Techns credit.

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