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Search Trainings
Live Webinar
NFPA 70E Arc Flash Training
This webinar training will define what an arc flash is and discuss how to prevent it from occurring. It will offer participants an understanding of the regulatory requirements of the NFPA 70E standard and detail how it applies to your facility. Participants wi ...
- Basic & Intermediate
- 60 Mins
- Joe Keenan
- Oct 19, 2021
Live Webinar
ICD-10-CM Changes for 2022
In 2015 the Federal Government in the United States mandated that fee for service providers assign ICD-10-CM codes to professional service claims for reimbursement. The ICD-10-CM codes are diagnosis codes that share with the insurance company on a medical in ...
- Basic & Intermediate
- 60 Mins
- Lynn Anderanin
- Oct 21, 2021
Live Webinar
The Transfer of Validated Methods
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Oct 26, 2021
Live Webinar
How to Write SOP's for Human Error Reduction
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...
- Basic & Advanced
- 90 Mins
- Ginette Collazo
- Oct 27, 2021
Live Webinar
QMS Structure and SOP Writing Essentials
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. That requires translating requirements into professionally written SOPs with adequate level of detail on how to do things. Excellent SOPs need mor ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Oct 28, 2021
Live Webinar
Software Validation for the New FDA Inspections
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Nov 03, 2021
Live Webinar
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usually by two-thirds, as ...
- Basic & Intermediate
- 90 Mins
- David Nettleton
- Nov 05, 2021
Live Webinar
How To Conduct A Human Factors/Usability Validation
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quanti ...
- Advanced
- 60 Mins
- José Mora
- Nov 17, 2021
Live Webinar
FDA Regulation of Artificial Intelligence / Machine Learning
AI / ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance’s for years, however, AI/ML programs fall outside the scope of these regulations an ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
- Nov 17, 2021
Live Webinar
How to manage an FDA Inspection
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during regulatory inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections effic ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Nov 18, 2021