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200 results of "Life Sciences x" and "FDA Compliance x"
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 ...

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 ...

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 ...

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 ...

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 ...

Live Webinar

Controlling Human Error in the Manufacturing Floor

Human error is known to be the major cause of quality and production losses in many industries.Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented.Human errors start at the design stage.Fro ...

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 ...

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 ...

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 ...

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Validity : 14th Oct'21 to 24th Oct'21