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Validation Practice Auditing Services
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.
- Audit,
Develop, Execute, Coordinate & Direct:
- Validation Master Plans
- Project Plans - Detailed plans
- User Requirements
- Functional Requirements (with appropriate matrices to
test cases)
- cGMP, GLP, ISO or ICH Summary Statements
- Design Qualification Protocol Development
- Design Qualification Component Check Lists &
Acceptance Criteria
- Installation Qualification Protocol Development
- Engineering Review, Qualification or Verification -
Drawings / Schematics / Ladder / Block / Flow
- Documentation Review - SOPs / Validation Protocols /
Technical Manuals / Process Standards
- Auditing - GMP, GLP, GCP, ICH and ISO Standards
Qualification / Verification
- Installation Qualification Component Inventories
- Installation Qualification Test Criteria & Summary
Reports
- Operational Qualification Protocol Development
- Risk Assessments & Analysis - 21 CFR Part 11
Assessments
- Test Case Authoring & Review
- Vendor Audit Summaries
- Execution of Test Cases
- Functional/User Requirements
- Operation Qualification Anomaly Analysis & Summary
Reports
- Installation Qualifications Protocols
- Performance Qualification Protocols
- Performance Qualification Test Cases & Acceptance
Criteria
- Validation Summary Report
- Validation Life Cycle Summary Report
- Validation Acceptance - Equipment / Process / Computer
Systems / Application Commissioning
-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.
-Conducted off-site desk and on-site vendor validation
audits and gap analysis
-Established Validation Steering Committees, Conducting
Progress Review, and Coordinate Start-ups
-Manufacturing Process Equipment Validation
-New Equipment Commissioning
-Class 100,000, 1000, 100 Qualifications
-Stability and Environmental Chambers
-Washers, Sterilizers and Autoclaves
-Pure, Process and Utility Water Systems
-Steam Systems (Clean and Utility)
-Packaging Systems and Packaging Processes
-Computer Systems and Software Validation
-Process Validation Audits
-'As-Builts' and CAD Drawing verifications
-Conducted Clinical Data Management Systems and
Statistical Program Validation
-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.
-Hired and managed validation personnel, teams and
contractors through project planning, Gantt development,
on-site project management and through project completion.
-Managed multiple validation projects
-Computer Systems and Software Applications
-GMP for Process and Facility
-Designing, validating and implementing Management Systems
for Pharmaceuticals and Biotechnology, Petrochemical and
manufacturing, contractor to engineering firms.
-Chaired Sponsor Audits by large Pharmaceuticals and Biotech
Companies in support of 'For Cause', 'Do Diligence' and FDA
483.
-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.
-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.
-Ready for short term contracts, Corp-to-Corp, 1099 or
temporary employee placement positions.
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