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34453 Conferences

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11

Added by Referral on 2011-07-01

Conference Dates:

Start Date Start Date: 2011-07-29
Last Date Last Day: 2011-07-29
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2011-07-29

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email:
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

Why Should You Attend:

In July 2010, the FDA announced that it will conduct a series of inspections related to 21 CFR Part 11. The FDA made it very clear that Part 11 is in effect and will be enforced according to original Part 11 and the Guidance from 2003.

While this guidance leaves a lot of room for interpretation and uncertainty, an excellent way to find out FDA's expectations is to learn from recent Part 11 related warning letters. From 2007-2011, there have already been more than 30 warning letters with deviations related to computer system validation and Part 11 compliance, some with disastrous consequences for inspected companies.

This webinar will explain the strategies to avoid warning letters using examples of recent 483’s and warning letters related to computer system validation.

Areas Covered in the Seminar:

- FDA inspections: Preparation, conducts, follow up.
- The meaning of warning letters and 483 inspectional observations.
- Learning from an FDA presentation: “Data Integrity and - Fraud - Another Looming Crisis?”Data integrity.
- FDA's new focus during inspections of computer systems and e-records.
- Examples of recent Part11 483’s and warning Letters.
- Examples of recent 483’ and warning letters related to computer system validation.
- Most obvious reasons for deviations.
- Responding to 483's to avoid warning letters.
- Writing corrective and preventive action plans to avoid 483.
- The future of Part 11and computer system validation.
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