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Good Validation Practice
Auditing Services |
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Our
experienced auditors perform all types of software, hardware and systems
validation audits, including departmental audits, vendor audits and other
project-related audits pertaining to electronic systems. Audits assess
compliance with SOPs and Good Clinical Practice, appropriate government
regulations/guidelines and ICH standards. |
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Audit, Develop, Execute,
Coordinate & Direct: |
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Validation Master Plans |
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Project Plans - Detailed plans
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User Requirements |
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Functional Requirements (with appropriate
matrices to test cases) |
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cGMP, GLP, ISO or ICH Summary Statements |
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Design Qualification Protocol Development |
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Design Qualification Component Check Lists
& Acceptance Criteria |
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Installation Qualification Protocol
Development |
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Engineering Review, Qualification or
Verification - Drawings / Schematics / Ladder / Block / Flow |
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Documentation Review - SOPs / Validation
Protocols / Technical Manuals / Process Standards |
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Auditing - GMP, GLP, GCP, ICH and ISO
Standards Qualification / Verification |
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Installation Qualification Component
Inventories |
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Installation Qualification Test Criteria &
Summary Reports |
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Operational Qualification Protocol
Development
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Risk Assessments & Analysis - 21 CFR Part
11 Assessments
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Test Case Authoring & Review
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Vendor Audit Summaries
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Execution of Test Cases
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Functional/User Requirements |
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Operation Qualification
Anomaly Analysis & Summary Reports |
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Installation Qualifications Protocols |
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Performance Qualification Protocols
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Performance Qualification Test Cases &
Acceptance Criteria |
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Validation Summary Report |
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Validation Life Cycle Summary Report |
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Validation Acceptance - Equipment /
Process / Computer Systems / Application Commissioning
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Implement turn-key Validation
programs, Computer Systems Software Development Life Cycle procedures,
Computer Systems Validation Guideline development, Audit Guidelines and
the 21 CFR Part 11 Guideline policy for Corporations.
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Conducted off-site desk and on-site
vendor validation audits and gap analysis
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Established Validation Steering
Committees, Conducting Progress Review, and Coordinate Start-ups |
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Manufacturing Process Equipment Validation |
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New Equipment Commissioning |
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Class 100,000, 1000, 100 Qualifications |
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Stability and Environmental Chambers |
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Washers, Sterilizers and Autoclaves |
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Pure, Process and Utility Water Systems |
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Steam Systems (Clean and Utility) |
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Packaging Systems and Packaging Processes
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Computer Systems and Software Validation
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Process Validation Audits |
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'As-Builts' and CAD Drawing verifications |
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Conducted Clinical Data Management Systems
and Statistical Program Validation
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Implemented Corporate Quality
Systems Initiatives in accordance with 21 CFR Part 11 mandates and
requirements. Assembled, trained and coordinated the Quality Systems
Steering Committee and developed the committee charter. Conducted Gap
Analysis, application inventories, repositories, and developed project
plans.
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Hired and managed validation
personnel, teams and contractors through project planning, Gantt
development, on-site project management and through project completion.
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Managed multiple validation projects |
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Computer Systems and Software Applications
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GMP for Process and Facility
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Designing,
validating and implementing Management Systems for Pharmaceuticals and
Biotechnology, Petrochemical and manufacturing, contractor to engineering
firms.
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Chaired Sponsor Audits by large
Pharmaceuticals and Biotech Companies in support of 'For Cause', 'Do
Diligence' and FDA 483.
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With over 22
years experience with various facets of company business from
Manufacturing to Research, Engineering to Formulations, cGMP, GLP, GCP,
ICH, GAMP, ISO to FDA, OSHA and EPA.
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Diversified
hands-on technical and engineering experience and five dedicated
accredited trade schools, my background and experience in many facets of
technical engineering, contracting and programming skills are invaluable
and I take pride in my diversity.
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Ready for short term contracts, Corp-to-Corp, 1099 or
temporary employee placement positions. |
