World Conference Calendar

34483 Conferences

Clinical Data Systems Regulated by FDA

Added by Compliance4all on 2017-11-16

Conference Dates:

Start Date Start Date: 2018-01-12

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email:
Address Address: 161 Mission Falls Lane, Suite 216,, Fremont, CA, 94539, United States
Phone Tel: 18004479407
Phone Fax: 302-288-6884

Conference Description:

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
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