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November 2017

Achieving and Maintaining 21 CFR Part 11 Compliance

November 6
VALIDATION ASSOCIATES, INC., 305 E. Pennsylvania Blvd.
Feasterville, 19053-7846 United States
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$595

This 1-day seminar reviews the requirements, FDA guidance and industry positions on the Electronic Records & Electronic Signatures rule. The seminar addresses enabling technologies and mechanisms to ensure that the system remains compliant throughout its lifetime.

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Computer System Validation in FDA-regulated Industries

November 7 - November 8
VALIDATION ASSOCIATES, INC., 305 E. Pennsylvania Blvd.
Feasterville, 19053-7846 United States
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$1195

This 2-day seminar includes an overview of validation tasks required by FDA Regulations and Guidelines.

The course content goes beyond simply "what" needs to be done - the emphasis is on "how" to accomplish computer system validation tasks.

The workshop format promotes hands-on, practical learning.

The Registration Fee includes attendance both days, continental breakfasts, lunches, and breaks, an attendee binder containing slides, handouts, and activities, and 30 minutes of follow-up validation consulting.

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Risk Management Applied to Computer System Validation

November 9
VALIDATION ASSOCIATES, INC., 305 E. Pennsylvania Blvd.
Feasterville, 19053-7846 United States
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$595

This 1-day seminar reviews the FDA regulations and industry guidance on risk assessment including GAMP, NIST, and ISO. The seminar addresses the process to complete Risk Assessment and Risk Mitigation activities as applied to computer system validation.

The Registration Fee includes attendance, continental breakfast, lunch, and breaks, and an attendee binder containing slides, handouts, and activities.

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Auditing Computer System Providers

November 10
VALIDATION ASSOCIATES, INC., 305 E. Pennsylvania Blvd.
Feasterville, 19053-7846 United States
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$595

This 1-day seminar focuses on the activities associated with planning and completing audits of computerized system providers. The session addresses evaluating the quality of validation deliverables, and is applicable to both internally developed and vendor supplied systems.

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December 2017

Computer System Validation Webinar

December 7 @ 1:00 pm - 3:00 pm EST
ONLINE/TELEPHONE
$265

Computer System Validation Webinar:
This 2-hour introductory session overviews the regulatory and business requirements for computer system validation in FDA-regulated industries. It includes a discussion of the issues surrounding the validation effort, and reviews the scope of the validation activities. The Registration Fee includes attendance, presentation slides, and session handouts.

(2-hour on-line Session)

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