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Functional and System Requirements for Systems Regulated by FDA - New Updates Included
Overview: Computer System Validation (CSV) has been regulated by FDA for more than 35 years, a..
Date : 28th June 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
EEO-1 Reporting Deadline Established For 2023! Prepare for Compliance!
Overview: The EEO-1 reporting deadline has become a moving target, so covered employers need ..
Date : 20th June 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Medical Device Cybersecurity following 2022 FDA Premarket Guidance
Overview: In this informative webinar, we delve into the critical field of medical device cyb..
Date : 20th June 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Engineering Change Control in Medical Device Environment
Overview:Change control focuses on managing changes throughout a product’s life cycle as a part of ..
Date : 30th March 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Good Documentation Practices to Support FDA Computer System Validation
Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..
Date : 29th March 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA
Overview: FDA has substantial authority to oversee regulated companies and their operations.&n..
Date : 30th November 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
510K Submission Process for Medical Devices
Level:- Beginner to Intermediate Overview: There are three types of 510(k) submissions t..
Date : 21st November 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Medical Device Software Validation Meeting FDA Regulations
Overview: Testing software to prove that it works and has no bugs is not sufficient to obtain ..
Date : 25th October 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Preventing Human Error in the Life Sciences - Pharmaceutical and Medical Device
Overview: Human Error occurs in all settings. In the world of pharmaceutical and medica..
Date : 29th July 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Writing Effective SOPs for the Medical Device and Pharmaceutical
Overview: Standard Operating Procedures (SOPs) are a critical ingredient in an effective and ef..
Date : 30th June 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Preventing Medical Device Recalls – A Prevention Strategy
Overview: In a recent study, the FDA has reported a 95% increase in medical device recalls ..
Date : 28th June 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices in Preparation for an FDA Computer System Audit
Overview: FDA requires that all computer systems used to produce, manage and report on “GxP” (G..
Date : 23rd June 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Preparing for an FDA Audit? Learn the Best Behavior Practices and the Do’s and Don’ts
Overview: This webinar will begin by discussing and emphasizing the importance of truthfulness..
Date : 20th May 2022
Time : This Event is Over
Duration : 75 Mins
Risk-based Design Control - The New Paradigm for Medical Device Design
Overview: Risk management overarches projects associated with a particular product family, giv..
Date : 17th February 2022
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 10 Mins
Writing Effective SOPs for the Medical Device and Pharmaceutical
Overview: Standard Operating Procedures (SOPs) are a critical ingredient in an effective and ..
Date : 18th November 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 02 Mins