Getting Started: The What, When & How of Creating a Manageable Validation Program

Does that need validation, too?

Creating an effective, comprehensive FDA-compliant computer validation program can appear overwhelming. In every corner there’s another computer system that just might need validating… it’s very tempting (and common) to conduct validations one-by-one as systems are uncovered by audits and inspections. The problem? This reactive approach almost guarantees that each inspection will reveal yet another system which requires validation, leaving your firm with a long trail of 483 observations, potential Warning Letters, or worse. Your costs will rise, your compliance profile and reputation will suffer.

An efficient validation program clearly demonstrates your quality to your current and potential customers, reduces business and regulatory risks and actively supports the training and infrastructure you need to help your company thrive.

You can get your computer systems under control, document your validation to FDA, and benefit from the resulting control…but where do you start?

On Thursday, November 15 at 1:00 EST, join FOI as Ofni Systems of Ofni Systems presents a 90-minute teleconference offering practical advice for getting started on an efficient, effective computer validation program, including generating your computer system inventory, creating validation master plans, and outlining a validation methodology appropriate for your business.

What You’ll Learn:

• Which of your computer systems need to be validated…and which do not.
• The documentation FDA investigators need to be sure your computer systems have been validated and are operating in a compliant manner.
• The differences between validation, qualification, user acceptance testing and internal quality – and when each is appropriate.
• Which regulations apply to your systems – and how you can document your compliance with those regulations.
• Considerations for ensuring compliance with 21 CFR 11 and Annex 11.
• What to ask suppliers when purchasing systems intended for GxP environments.
• Industry best practices you can use to help maximize your validation resources.
• How to involve system owners, users and quality in maintaining compliance.

What You’ll Get:

• Help in evaluating your computer systems to determine if validation is required.
• An example of a Validation Master Plan and suggestions for tailoring it to suit your organization.
• A checklist to help identify gaps in Part 11 compliance.
• A look at a sample of a commercial program intended to help you manage validation activities.
• An experienced, approachable instructor.
• Time for questions and answers.

Who Should Attend:

• Managers and staff from FDA-regulated firms involved in validation activities from program design through quality control.
• Anyone researching, selecting and purchasing computer systems that will be used in GxP environments.
• Information technology professionals responsible for file administration or network locations storing databases containing GxP data.
• Quality professionals responsible for designing, evaluating and verifying computer system compliance.
• Executives developing strategic corporate plans and resource allocation.