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 Seminar Id: IJ2018S5
 06:00 AM PT | 09:00 AM ET
 Duration 1 Day

How to Handle HIPAA and HITECH Act Breaches, Complaints and Investigations: Everything You Need to Know

Every covered entity and the business associate will experience one or more security incidents every year. Such incidents range from an employee forgetting to log off with no harm done because you caught it before any unauthorized person accessed the computer to a ransomware attack in which you must pay a six-figure ransom to access your data. Serious breaches require the covered entity to report the matter to the Department of Health a........

 Seminar Id: IJ2018S4
 6:00 AM PT | 9:00 AM ET
 Duration 1 Day

Preparing for The New EU Medical Device Regulations (MDR): Strategies and Tactics

The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2017. From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules. Given the large scale of changes, there is great pressure on all actors to analyze the MDR, conduct impact assessments, and implement compliant process........

 Seminar Id: IJ2018S3
 05:30 AM PT | 08:30 AM ET
 Duration 2 Days

Computer Systems Validation (CSV) and Data Integrity

This interactive 2-day conference and workshop is for novices, advanced users, senior management and others who use computer systems for laboratories, clinical trials, manufacturing, quality and validation. This unique conference explores the latest industry standards such as GAMP V for validating data integrity, data access security, data transfer, data migration and audit trails. Addressed will be the development of dynamic programs d........

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