Clinical Data Systems Regulated by FDA

Fremont, CA
Clinical Data Systems, Tobacco Industries, System Validation Specialists, GMP Training Specialists, Business Stakeholders, International Conference on Harmonization

Companies engaged in the conduct of human clinical trials must adhere 

to specific government regulatory requirements.Certain documents, 

content and images related to a clinical trial must be stored and 

maintained, and depending on the regulatory jurisdiction.

Why should you Attend:
You should attend this webinar if you are responsible for establishing or 

maintaining a TMF, or providing quality assurance for data included in 

the file. This webinar will also benefit those involved in the conduct of 

clinical trials, audit and inspection of clinical trial study data and 

records, and submission of filings to regulatory agencies that involve 

clinical trial data. 

Areas Covered in the Session:
Learn what content is required for a TMF for a clinical tria
Learn about best practices and industry standards
Understand the importance of developing an effective Standard 

Operating Procedure

Who Will Benefit:
T Support Staff
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Compliance Managers and Auditors
Lab Managers and Analysts
Computer System Validation Specialists
GMP Training Specialists

Speaker Profile:
Carolyn (McKillop) Troiano has more than 35 years of experience in the 

tobacco, pharmaceutical, medical device and other FDA-regulated 

industries. She has worked directly, or on a consulting basis, for many 

of the larger pharmaceutical and tobacco companies in the US and 

Europe, developing and executing compliance strategies and programs.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

Schedule of Presentations:

Friday, January 12, 2018
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