training (general)

  1. M

    Courses / Workshops on Registration of Medical Devices WW

    Dear All, Do you know about any specialized courses on the registration of medical devices in specific countries/regions like LATAM, Russia and CIS, MENA etc? I found some in USA and UK, but I wonder if there is anything more available. It would be great if the courses were in English or...
  2. R

    How to SHOW the importance of checklists, through some team gaming or play?

    Hope my topic fits here on TRAINING. My company has an annual "QUALITY Day", where we usually have some team buildings games, some talks, coffee break and some comedy show for the employees We recently decided we would scrap the external shows, and focus on gaming... specially, try to have a...
  3. I

    ISO 9001:2015 - On the Job Training and Records

    I'm looking at an old internal corrective action relating to a lack of training records for a customer service team. It brings back the question, if someone is hired for a specific role and their ongoing "on the job" training covers a topic, can an auditor expect to see separate records for...
  4. I

    What level of change in documentation requires re-training?

    This seems like one of those areas that's a judgement call, but I've been doing a lot of document changes lately and one of the questions that I'm considering as well as getting it form others, is ow to determine if re-training is required when one changes a process document? Obviously changes...
  5. cscalise

    Determination of CPD (Continuing Professional Development) hours for a training course

    Hello, I am in the process of developing seminar and online training courses and would like to include CPD hours. Does anyone have experience with this? Is there a formal calculation? I have found some information and believe these courses would be classified as Informal Activity (1 hour of...
  6. L

    Training Timeliness

    I work in Medical Device Quality Systems and identified the need to review timeliness of training. Some of our QMS procedures have due dates of 60 or 90 days past release date, but decisions on this timing does not seem to be consistent or relative to risk. What are some good resources I can use...
  7. J

    Your opinion on the better training org for IATF16949 Internal auditor and Lead Auditor

    Hi team, your opinion on the better training org for IATF16949 Internal auditor and Lead Auditor. IRCA or Exemplar Global? Thanks, jack
  8. A

    Who champions your internal manufacturing training?

    Hello All, We are having some troubles with HR continuing to want to champion all our internal training as they have done for the last 20+ years. Now they only want to be responsible for parts of it so those of us in QA are scrambling to find another "owner" for all the other training that the...
  9. I

    Who owns your Competence, Awareness and Training process?

    ISO-9001 requires that companies address CA&T, but I'm wondering what group within your organizations past or present actually owns that process? Is it your HR team? Operations? Or do you have a separate Training group who owns it?
  10. pbojsen

    Computerized Learning Management Systems (Training systems) recommendations?

    We are a medical device manufacturer, and I am looking for any recommendations or experience anyone may have with a computerized learning management system, i.e. a training system. We currently are using Cornerstone LMS but are looking to change. Preferably with something that can integrate with...
  11. J

    Training documentation - ISO 13485 audit and the auditor had questions

    We recently had an ISO 13485 audit and the auditor had the questions below. Are there different ways to make sure the candidate is competent in the particular standard? How did you update to new standard? How do you know the candidate is good for internal audit for ISO: 2016 standard? Does...
  12. N

    Are Manufacturing Personnel Required to ReDemonstrate after intital Demonstrations?

    I currently work for a medical device cell culture company that adheres to 21-CFR-820, 21-CFR-210, 21-CFR-211; ISO9001 and ISO13485. Within our training program, we train manufacturing personnel using a combination of OJT and computer-based learning. We have personnel demonstrate and record that...
  13. J

    ASQ Chicago Training Institute - If any of you are interesting in teaching ASQ Certification preparation

    We are revamping the training institute. If any of you are interesting in teaching ASQ Certification preparation, SPC, MSA, Six Sigma certificate preparation etc., please let me know. I appreciate, ASQ Chicago is a great asset for training to local students at very minimum cost. Regards, Jit...
  14. S

    Quality System Induction Training for New Employees

    Hi All, Im looking at improving our current "9001/14001 Induction Training" for new employees. The current induction thats being done is very dull and need to be spiced up a bit, to make it more attractive to the new employee. Does anybody have a template or even slide show i can use to adapt...
  15. R

    Creating WIs for a Heavy Civil Engineering Services company

    The nomenclature is not important here. Objective is to have good material to give training, to workers to see and understand the steps in their jobs. So, for example. A road has a subgrade (existing soil, which must be levelled with a motorgrader), a subbase (if needed), a base and the top...
  16. E

    Informational I would like to get some Internal Auditor Training

    Hi All, I'm a new first time quality manager at an ISO 9001:2015 certified company, and would like to get some training on internal auditing to get me started off in the right direction as well as to get some evidence that I have training / competency. I found a couple online training courses...
  17. Q

    Have you ever "excluded" certain job descriptions from the QMS?

    In order to fill gaps in our Training, I assigned relevant procedures for each Job Description at our company. I created this matrix based on on the documented job description and the extent to which I felt that position was involved with the documents/procedures. My Controlled threw a fit...
  18. Q

    Identification of Training Needs = People Performance?

    Hi everybody I have heard of a practice in ISO 9001 which is named " Identification of training needs" which runs yearly or a every six months, the idea is to identify needs of trainings for people. I wonder what relationship it has with the measuring the performance of people? Which is...
  19. pammesue

    So much turnover, How to improve our training process?

    We are really struggling with finding and keeping new employees. We generally have a 2.5% unemployment rate in the area, so everyone that wants a job is already employed. We start all employess out in the same area. It is hot in here and they actually have to do some physical labor. We start...
  20. L

    Verifying training effectiveness for procedure changes

    Hi all, My company implemented all required changes for ISO 13485:2016, including verification of training effectiveness based on risk. Our procedure includes quizzes or demonstration of knowledge for high risk, discussions for medium risk and monitoring for low risk. This has been...
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