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As drug and device companies continue to outsource functions to cut costs and increase productivity, the software industry is stepping up to the plate. In fact, most offer an add-on package they say will help integrate their product into a client’s validation effort.
But don’t just rely on vendors’ claims. As drug and device firms have already discovered the hard way:
All of this can be avoided by understanding the risks inherent in vendor-supplied validation packages — and asking the right questions — before making the purchase.
Software validation expert Carlos Morgado tells you what you need to know before purchasing validation packages, how to reduce the common risks associated with them and tips on incorporating them into their in-house validation master plans.
Order now for your entire team to listen in and discover:
Ensure the validation tools supplied by outside vendors will meet the FDA’s and your internal standards and allow you to seamlessly integrate with your in-house validation efforts.
Carlos Morgado is an associate director with CSI Validation and Compliance Services. He has over 20 years of software quality assurance-related experience, of which 14 are in an FDA-regulated environment. In his role at CSI, Carlos is responsible for providing FDA-regulated companies with compliance and validation consulting services. He has provided clients with strategic and tactical services associated with, but not limited to, implementation of QA systems to support IS/IT operations in an FDA-regulated environment, network/infrastructure qualification, validation of Adverse Event Reporting Systems, LIMS, Data Acquisition and Accessioning System, SAS, various 21 CFR Part 11 inventory (including assessments and remediation activities) and other ERP system validations.
Carlos joined CSI in December 2003. Prior to CSI, he was a senior manager in charge of the North East IT Compliance Services group. He managed and executed compliance and validation projects on a variety of different computerized systems. Specific project responsibilities included, but were not limited to: validation project planning and management, document QA, preparation of system specifications, qualification test protocols, development of standard operating procedures, on-site testing, data analysis, preparation of final reports, 21 CFR Part 11 compliance assessments, contingency and remediation planning. Carlos has also performed numerous audits of software suppliers on behalf of clients. He is a frequent speaker at FDA regulatory conferences on various topics that apply to compliance and validation.
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