• Risk Management Applied to Computer System Validation

    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.

    REGISTER HERE

  • Computer System Validation in FDA-regulated Industries

    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.

    REGISTER HERE

  • Achieving and Maintaining 21 CFR Part 11 Compliance

    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.

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

    REGISTER HERE