Robert Barber Email & Phone Number

Director of Validation ServicesProject Lead CSV Validation21 CFR Part 11 AssessmentsSOP’s• Review/verify quality documentation• Direct the project team in SLC methodology• Provide regulatory expertise and oversee adherence to regulatory compliance (GxP)• Align regulatory compliance with corporate strategy and internal policies and practices• Direct the project team in quality and compliance issues and practices• Demonstrate and enforce ethics and integrity in all internal and regulatory practices• Provide project management and process guidance to project team• Direct good validation and documentation practices and manage development of the associated validation documents

Director of Validation ServicesSr. Validation Consultant/Project Lead CSV Validation21 CFR Part 11 AssessmentsSOP’s• Review/verify quality documentation• Direct the project team in SLC methodology• Provide regulatory expertise and oversee adherence to regulatory compliance (GxP)• Align regulatory compliance with corporate strategy and internal policies and practices• Direct the project team in quality and compliance issues and practices• Demonstrate and enforce ethics and integrity in all internal and regulatory practices• Provide project management and process guidance to project team• Direct good validation and documentation practices and manage development of the associated validation documents

Sr. Validation Consultant/Project Manager/Team Lead• Review/verify/approve quality documentation• Direct the project team in SLC methodology• Provide regulatory expertise and oversee adherence to regulatory compliance (GxP)• Align regulatory compliance with corporate strategy and internal policies and practices• Direct the project team in quality and compliance issues and practices• Demonstrate and enforce ethics and integrity in all internal and regulatory practices• Provide project management and process guidance to project team• Institute and communicate policies, procedures, guidance and work plans through meetings, email, and in person training sessions• Direct good validation and documentation practices and manage development of the associated validation documents

• SOPs, Scientific documents, PSUR, Procedural documents, Data review

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