The training procedure and webinar will teach you how to establish training requirements, conduct training, and verify competency.
The video below shows you exactly what you will receive when you purchase Medical Device Academy’s Training Procedure (SYS-004). The purpose of this procedure is to ensure that you understand what is included in the purchase of the procedure, how to complete the training matrix, and how to complete the training record. We also suggest how you might customize the various documents included in the package. The procedure is written for compliance with ISO 13485:2016.
What is the purpose of the Training Procedure?
The purpose of the training procedure is to define your process for documenting training requirements, training employees, and verifying competency for work that may affect product quality or other functions essential to the business on the basis of appropriate education, training, skills, and experience. This procedure applies to staff who undertake activities that may have an impact on the quality or safety of products. The training procedure includes competency assessment when staff is recruited, training of staff according to quality management system documentation, and the planning and recording of more general training.
When is the Training Procedure Webinar?
The training procedure webinar will be hosted on July 29, 2024 @ 10:30 a.m. ET. The webinar will be live, and you will receive login instructions if you purchased the training procedure prior to the scheduled live webinar. The webinar will also be recorded. You will be able to download the webinar from our Dropbox folder and watch the webinar as many times as needed–including the training of future employees.
Training Procedure (SYS-004) Contents
The following documents are included with this purchase. This procedure has been updated to the requirements of ISO 13485:2016 and simplified for easier implementation by start-up companies. The following items are included with the purchase of the training procedure:
- SYS-004 Training Procedure
- FRM-002 Training Record
- FRM-026 Training Matrix
- FRM-046 New Employee Checklist
- Native slide deck
- Login information for the live webinar (if purchased on or before July 29, 2024)
- Recording of the webinar (after July 29, 2024)
Description of FRM-002 – Training Record
Record of training for a group of people or an individual, often associated with the release of a version of a document or group of related QMS documents but also used for other purposes. Supporting material, e.g. the course outline for external training may be attached to the form as part of the record, or competency assessment records specific to the training, e.g. quiz results…
Documenting Training Requirements
The FDA also requires that there are documented training requirements. Therefore, the procedure identifies the need to create a job description that includes training and competency requirements. The procedure does not, however, require that the job descriptions be maintained as controlled documents. If your company has multiple people with the same job function (e.g., customer service), then it might make sense to have a controlled document that is a job description for customer service. A company with four employees does not need controlled documents, and instead, a unique record for each employee makes more sense.
Updating Training Procedure to Explain How to Complete Forms?
The procedure still references a training record for documenting training, but now there is also a reference to a training matrix to help document training requirements for each employee. Instead of providing detailed training instructions on how to complete the training record (FRM-002) or the training matrix (FRM-026), instead, we provided a video above that explains how to fill in the forms. This makes it easier to review the procedure for regulatory compliance and puts the details on how to complete forms in the training curriculum where it belongs.
Electronic Delivery of the Training Procedure
This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for a subscription confirmation email. If you do not confirm your subscription you will not receive the three documents or any future updates. Future updates to the procedure or forms are at no charge to subscribers.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below:
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.