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GlobalCompliance Panel
Добавлен 4 авг 2011
GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.
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
API
Biotechnology
Clean...
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
API
Biotechnology
Clean...
Просмотров: 1 607
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
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
Great webinar. Thank you😊
True expert
Thanks for the information
This place is an email spam factory.
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.
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.
Thank you for your information. I learned, understand well
arrest the medical mafia
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?
Thank you for the content. Very helpful! Is it possible to receive a copy of this powerpoint presentation?
I miss you papa. I love you. You’re amazing.
This is a great presentation
What an incredibly, clear, and to the point presentation
How can i get pdf of this presentation?
Thanks I really appreciate your explanation, it was definitely very clear and educated.
Still a very good training material today! Thank you!
Seriously get rid of that straw Dan
Very good overview of validation principles, thank you very much
I wish i read the comment. No content here!
Great session
Thank you, I learned a lot from this webinar
Fantastic overview! I am saving for reference. Please let me know if there is an updated version. Great job!
The sound in the video cuts off at minute 45. Can you reupload the video and verify that the sound works after minute 45?
Nice job Thorough, formal, technical and to the point. Thank you Sir
ruclips.net/channel/UCyB3GFq6cWuAZzGWpnTX70A
sterilization is definitely design output, biocompatibility aswell
Thank you🙂
A nice presentation. This gal knows her stuff. Thank you
sir i want some book suggestion where i get knoledge abou this think
This gal knows her stuff. I have heard her other presentations on your channel. Melinda is an amazing speaker
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.
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 🙏🙏🙏
Didn't even understand half the words? What is the document he said download. I couldn't make out the word cusid?
What is cusid?
It's QSIT- Quality System Inspection Technique. Google for examples.
nice
Very nice. Information was much appreciated
Good information. Thank you
Very helpful video
Excellent presentation Thank you folks
Can i Get this course certification
can you upload slide show pdf, it'll be fantasic
Very good information sir, Is analytical development formulation department is come under A R&D in pharma industries.
Outstanding job Dan!
Good stuff Shes good at presenting
Introduction to regulatory affairs. Scope and Opportunities of Regulatory Affairs . ruclips.net/video/GsROKXAT93M/видео.html
What a complex protol(s) to follow!!!!! excellent information and clinically sound, thank you!!!!!
Extremely clear, concise overview of the FDA drug approval process. Thank you!
Nice job Mr O'leary
Thanks for the great overview!
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.