Options/suggestions for external training in risk management and design controls

Hi,
My company has an ISO 13485 certified QMS - we manufacture IVD Medical Devices. I am looking to outsource training in the areas of risk management so that we can write and implement an effective system. I would also like to get training on design controls and overall design and development systems. My company is very weak in this area, and I want to send people out to get training ASAP. Anyone have suggestions or recommendations of companies that provide training on these topics? We are small and cannot afford on-sight training (or so my boss tells me).

 

There are web-based training that you can take at an affordable cost to your organization. Then you can supplement your training with this forum. The moderators here provide a well-spring of knowledge that you cannot get from a classroom training.

 

Another source is state colleges - most states have manufacturing extension programs that work with businesses on specific issues. The best thing about these programs is that the costs can be underwritten by grants. The ones I've worked with have even handled all the grant writing and are willing to tailor the training to your companies specific needs. They can also come in house to do the training. I did a quick search and this site: http://omep.org/ came up. It might be worthwhile to check them out. I've had great experiences with the programs I've worked with.

Good luck!

 

I completely agree!

My suggestion would be to hire a temporary knowledgeable/experienced consultant to work hand-in-hand with the personnel you want to train, to improve your system.

This arrangement has the following advantages:

• It's more personalized than a classroom setting (you can interact with, ask questions etc. one-on-one)
• It uses a real-world situation in which people have personal investment in improving (good motivator to learn)
• You get actual work done that improves the company as you learn
• There are no time constraints. You can keep the consultant on as long as is necessary until YOU (and the personnel) are satisfied with the knowledge gained

Really, the only benefit I can see with a classroom over this arrangement is a formal "certificate". ...which, in my opinion, doesn't mean a whole lot...

 

Consider Marcelo Antunes for this task. He is a consultant/trainer and participates in this Forum. He is very knowledgeable of Medical Devices QMS and Regulations and offers Risk Management courses for medical device manufacturers.

Good luck.

 

I agree that bringing in a consultant to address the problems head on and learn from them at the same time would be the most solid and timely solution, but I've been told that I cannot bring on consultants (there is a bad taste in executive management's mouth from a previous situation). And with how remote we are it would be difficult to "get someone in here" - it would probably all be virtual, which isn't as effective (IMO). But, I am going to keep pushing for this.
In the meantime I have approval to attend training, but don't have any experience with training companies besides BSI -Internal auditor course. What I would like is recommendations (or cautions against) companies that provide classroom or online training. I have done some webinars from OnlineCompliancePanel.com and Life Science Training Institute (LSTI) but found them too broad or just not enough detail to troubleshoot or develop our process from. Anyone have experience with Oriel Stat A Matrix? Or know of others?

 

Can you specify what ones you recommend?

 

Just checking in to see if anyone has suggestions... Anyone used Oriel Stat A Matrix for training? It's one I came across during my online searching...

 

Also, I just found this company with training options: Center for Professional Innovation and Education https://www.google.com/url?sa=t&rct...H9_HjMnoDNF7-QQmQ&sig2=rNFu4QjkBYBfZvtsdx2Cpw
They have some medical device specific courses. Anyone taken them before? Thoughts? Cautions?