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Clinical Data Systems Regulated by FDA


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Who should attend?

IT Developers IT Support Staff QC/QA Managers and Analysts Clinical Data Managers and Scientists Compliance Managers and Auditors Lab Managers and Analysts Computer System Validation Specialists

Details

Overview:  
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.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Prices

One Dial-in One Attendee Price: $150.00

Contact

Event Manager
support@compliance4all.com

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