GlobalCompliance Panel
GlobalCompliance Panel
  • Видео 155
  • Просмотров 720 346
Professional Courses | List of Training Courses - Seminars
Having started out as a training provider for this segment; GlobalCompliancePanel has accumulated total knowledge of the medical devices industry. With its long experience and in having several leading names in the medical devices industry on its panel, GlobalCompliancePanel covers all areas of medical devices comprehensively.
These are just some of the areas GlobalCompliancePanel offers trainings in:
cGMP Principles
Medical Device Changes and the 510(k)
ISO 9001
ISO 13485
ISO 14001
Medical Device Regulatory and Quality Requirements
Process Validation for Medical Devices
CAPA for the Medical Device Industry
Read More: www.globalcompliancepanel.com/seminar?youtube-SEO
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Видео

successfully completed seminar on "The New Clinical Trials Regulation 2017"
Просмотров 1977 лет назад
successfully completed seminar on "The New Clinical Trials Regulation 2017" www.globalcompliancepanel.com/ Help us caption & translate this video! amara.org/v/4rRG/
How to build a complete Safety, Health & Environment Management System 2017
Просмотров 4707 лет назад
Course "How to build a complete Safety, Health & Environment Management System through Standards & Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal docum...
successfully completed seminar on Statistics for the Non-Statistician
Просмотров 3267 лет назад
successfully completed seminar on Statistics for the Non-Statistician Help us caption & translate this video! amara.org/v/4Gkc/
Understanding Attribute Acceptance Sampling including Z1 4 and c=0 Plans
Просмотров 12 тыс.8 лет назад
Imagine this! Your company uses acceptance sampling in your manufacturing process and your manager asked to make sure it is cost effective. She also knows there is some risk associated with sampling, but she admits she doesn't completely understand it. You now have a new assignment; assure your manager that you have good balance between risk and cost. The person who set up the system retired a ...
Requirements Contents and Options : The 510k Submission
Просмотров 1,6 тыс.8 лет назад
This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This video will describe the submission process and the contents required by the FDA for a successful submission. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: www.globalcompliancepanel.com/ Email: support@globalcomplia...
Statistical Concepts of Process Validation
Просмотров 19 тыс.8 лет назад
If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material. This is the essence of the statistical approach. This video presents the statistical approach that will help you validate your processes. Your team should attend t...
Medical Devices - ISO 14971 : Risk Management
Просмотров 28 тыс.8 лет назад
This course provides the attendees with an overview of ISO 14971:2007 and implementation tips for an effective system for managing risk. We provide an overview using flow charts that shows each of the elements of a Risk Management system and how they fit together. This approach helps the participant understand the essential structure and the required elements. For More Information Contact - Org...
What to do during recalls, removals, and market corrections
Просмотров 9448 лет назад
There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent, but not completely. This video sets forth the requirements for recalls, removals, and market corrections, and provide...
Purchasing and Supplier Controls in the Medical Device Industry
Просмотров 1,6 тыс.8 лет назад
Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evalua...
Protocols for Medical Devices & Process Validation Principles
Просмотров 6 тыс.8 лет назад
The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit. Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. Thes...
Process Validation Procedure for Medical Device Manufacturers
Просмотров 7 тыс.8 лет назад
This Process validation training/webinar for medical device manufacturers will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop Process Validation Plans and conduct production Process Validation. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: www.globalcompliancepanel.com/ Email: support@globalcompliancepanel.c...
Outsourced processes and ISO 9001:2008
Просмотров 7248 лет назад
This video explains the changes in ISO 9001:2008 related to outsourced processes. While the literature says this new version only contains clarifications, this clarification can have a big impact on a Quality Management System. We look to ISO's guidance document on outsourced process to ensure we understand the intent. For More Information Contact - Organization: NetZealous BDA GlobalCompliance...
Medical Device Design Control
Просмотров 13 тыс.8 лет назад
Understanding, interpreting, and implementing design control requirements in a holistic manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment. In this presentation, you will get familiar with regulatory and quality requirements of design control conc...
Medical Device Complaint Handling Systems
Просмотров 2,3 тыс.8 лет назад
This Video is intended to demonstrate how to adequately establish and maintain medical device complaint handling systems. All medical device manufacturers are required to comply with the complaint handling requirements. Understanding the relevant and applicable requirement can significantly contribute to achieving compliance and remaining compliant, resulting in saving significant amount of tim...
Medical Device Adverse Event Reporting in EU, US and Canada
Просмотров 4 тыс.8 лет назад
Medical Device Adverse Event Reporting in EU, US and Canada
Managing the Medical Device Supply Chain
Просмотров 1,4 тыс.8 лет назад
Managing the Medical Device Supply Chain
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Просмотров 2,6 тыс.8 лет назад
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Ensure data integrity and subject safety in clinical research
Просмотров 1,1 тыс.8 лет назад
Ensure data integrity and subject safety in clinical research
FDA Requirements for Device Labeling
Просмотров 3,2 тыс.8 лет назад
FDA Requirements for Device Labeling
How to prepare for an FDA inspection
Просмотров 2 тыс.8 лет назад
How to prepare for an FDA inspection
Understand the FDA device regulations related to Excel spreadsheets
Просмотров 1,3 тыс.8 лет назад
Understand the FDA device regulations related to Excel spreadsheets
Equipment Validation, Tracking, Calibration, and Preventive Maintenance
Просмотров 3,8 тыс.8 лет назад
Equipment Validation, Tracking, Calibration, and Preventive Maintenance
How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner
Просмотров 5628 лет назад
How to Meet FDA QSR and ISO 13485 Requirements in a Relatively Paper-Free Manner
Regulatory Documents Explained - DHF, DMR, DHR and TF
Просмотров 6 тыс.8 лет назад
Regulatory Documents Explained - DHF, DMR, DHR and TF
FDA QSR Requirements for DMR & DHR
Просмотров 6388 лет назад
FDA QSR Requirements for DMR & DHR
Recalls, Corrections and Removals (Devices)
Просмотров 3058 лет назад
Recalls, Corrections and Removals (Devices)
Effective Audit Program for both internal and external Processes
Просмотров 1,7 тыс.8 лет назад
Effective Audit Program for both internal and external Processes
FDA Quality Systems Regulation Requirements - Regulatory Documents Explained
Просмотров 8 тыс.8 лет назад
FDA Quality Systems Regulation Requirements - Regulatory Documents Explained
cGMP for Medical Devices Including IVDs
Просмотров 1,7 тыс.8 лет назад
cGMP for Medical Devices Including IVDs

Комментарии

  • @carol_hyejinkim
    @carol_hyejinkim 4 месяца назад

    Great webinar. Thank you😊

  • @yumingzhao5577
    @yumingzhao5577 5 месяцев назад

    True expert

  • @user-gl2ux3dr1j
    @user-gl2ux3dr1j 6 месяцев назад

    Thanks for the information

  • @Anon-up3be
    @Anon-up3be 7 месяцев назад

    This place is an email spam factory.

  • @timglover4180
    @timglover4180 8 месяцев назад

    Really good video content and really helpful! Unfortunately I had to listen to it multiple times and keep rewinding as the sound was quite muffled, I tried it on multiple devices.

  • @benlee3545
    @benlee3545 11 месяцев назад

    hi, your video is good. you also share some of the experience you have in software but it will be better if you can include examples of the device master record for clearer illustrations and templates etc.

  • @ysshaikali1643
    @ysshaikali1643 Год назад

    Thank you for your information. I learned, understand well

  • @jerrylee2698
    @jerrylee2698 Год назад

    arrest the medical mafia

  • @lissaoneill8008
    @lissaoneill8008 Год назад

    44:50 Stock Recovery. Interested to know would this be considered stock recovery?: manufactured lot has known defect. Some part of lot was distributed but it is known that all distributed devices were used up with no harm. The firm still decides to destroy what's left in stock - would this be a stock recovery since it is known nothing is currently in distribution or it is no longer stock recovery since part of lot had been distributed and it doesn't matter whether there is nothing in distribution anymore?

  • @SamHarmony2
    @SamHarmony2 Год назад

    Thank you for the content. Very helpful! Is it possible to receive a copy of this powerpoint presentation?

  • @AbbyGhignone-yy7yt
    @AbbyGhignone-yy7yt Год назад

    I miss you papa. I love you. You’re amazing.

  • @beaudyorcel4987
    @beaudyorcel4987 Год назад

    This is a great presentation

  • @sonandpets1215
    @sonandpets1215 Год назад

    What an incredibly, clear, and to the point presentation

  • @NazrulIslam-kb2tt
    @NazrulIslam-kb2tt Год назад

    How can i get pdf of this presentation?

  • @liorx10
    @liorx10 Год назад

    Thanks I really appreciate your explanation, it was definitely very clear and educated.

  • @CityWalkSHA
    @CityWalkSHA Год назад

    Still a very good training material today! Thank you!

  • @davidmuseau1406
    @davidmuseau1406 Год назад

    Seriously get rid of that straw Dan

  • @tinthings314
    @tinthings314 Год назад

    Very good overview of validation principles, thank you very much

  • @dorrinasefi9400
    @dorrinasefi9400 Год назад

    I wish i read the comment. No content here!

  • @SanthoshKumar-np8pr
    @SanthoshKumar-np8pr Год назад

    Great session

  • @fadumaali5738
    @fadumaali5738 Год назад

    Thank you, I learned a lot from this webinar

  • @davidfrancis1299
    @davidfrancis1299 Год назад

    Fantastic overview! I am saving for reference. Please let me know if there is an updated version. Great job!

  • @caseykrauter3422
    @caseykrauter3422 Год назад

    The sound in the video cuts off at minute 45. Can you reupload the video and verify that the sound works after minute 45?

  • @kkwok9
    @kkwok9 Год назад

    Nice job Thorough, formal, technical and to the point. Thank you Sir

  • @gxpmatters5705
    @gxpmatters5705 2 года назад

    ruclips.net/channel/UCyB3GFq6cWuAZzGWpnTX70A

  • @daltonymd8391
    @daltonymd8391 2 года назад

    sterilization is definitely design output, biocompatibility aswell

  • @sanketmane7109
    @sanketmane7109 2 года назад

    Thank you🙂

  • @kkwok9
    @kkwok9 2 года назад

    A nice presentation. This gal knows her stuff. Thank you

  • @abhilovemarvel1810
    @abhilovemarvel1810 2 года назад

    sir i want some book suggestion where i get knoledge abou this think

  • @kkwok9
    @kkwok9 2 года назад

    This gal knows her stuff. I have heard her other presentations on your channel. Melinda is an amazing speaker

  • @bobtan9321
    @bobtan9321 2 года назад

    Sounds impressive but don't be taken in. NOt listed is Preventing doctors from seeing Clinical Trial Data. As it is clear, many of you are not aware of Pfizer's clinical trial data being locked up for 75 years by our boys at the FDA. Also not listed is the dictatorial ruling by the FDA to ignore the warning of the Advisory Committee on Vaccines, "Members of the FDA advisory committee struck a skeptical tone during the meeting Friday, questioning Pfizer's conclusions that immunity is waning to the point that vaccinated people of all ages" It is sad that so many people that should know better are duped by an FDA that's been running amuck. Houston, we've got a problem, a huge problem of integrity. And we are all being played.

  • @shivakumar-ll6ro
    @shivakumar-ll6ro 2 года назад

    Sir can you please explain me in standard iso 2859 or is 2500 Based on lot size and sample size we have accept and reject numbers I want to know how those accept and reject numbers are calculated and created .... please do needful 🙏🙏🙏

  • @TeW33zy
    @TeW33zy 2 года назад

    Didn't even understand half the words? What is the document he said download. I couldn't make out the word cusid?

  • @TeW33zy
    @TeW33zy 2 года назад

    What is cusid?

    • @jlak892
      @jlak892 2 года назад

      It's QSIT- Quality System Inspection Technique. Google for examples.

  • @paragkale5459
    @paragkale5459 2 года назад

    nice

  • @kkwok9
    @kkwok9 2 года назад

    Very nice. Information was much appreciated

  • @kkwok9
    @kkwok9 2 года назад

    Good information. Thank you

  • @jennifercamison3815
    @jennifercamison3815 2 года назад

    Very helpful video

  • @kkwok9
    @kkwok9 2 года назад

    Excellent presentation Thank you folks

  • @parveshthakur2979
    @parveshthakur2979 2 года назад

    Can i Get this course certification

  • @nguyentung5406
    @nguyentung5406 3 года назад

    can you upload slide show pdf, it'll be fantasic

  • @BharathKumar-gm5zz
    @BharathKumar-gm5zz 3 года назад

    Very good information sir, Is analytical development formulation department is come under A R&D in pharma industries.

  • @tlm7790
    @tlm7790 3 года назад

    Outstanding job Dan!

  • @kkwok9
    @kkwok9 3 года назад

    Good stuff Shes good at presenting

  • @orisolesolutions3867
    @orisolesolutions3867 3 года назад

    Introduction to regulatory affairs. Scope and Opportunities of Regulatory Affairs . ruclips.net/video/GsROKXAT93M/видео.html

  • @kevinkane6418
    @kevinkane6418 3 года назад

    What a complex protol(s) to follow!!!!! excellent information and clinically sound, thank you!!!!!

  • @genekim1426
    @genekim1426 3 года назад

    Extremely clear, concise overview of the FDA drug approval process. Thank you!

  • @kkwok9
    @kkwok9 3 года назад

    Nice job Mr O'leary

  • @misa143me4
    @misa143me4 3 года назад

    Thanks for the great overview!

  • @DanielaGutierrez-ck3xs
    @DanielaGutierrez-ck3xs 3 года назад

    And another question is: Is it necessary to check normality, before applying control chart? And if the data does not meet normality we need to implement a control chart for no parametric data? Regards, Daniela G.