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Maria & John Montana are project/program managers, and Regulatory Compliance Engineers
with over 60 years combined experience in the Information Technology, Quality Assurance, and Compliance fields with a speciality
in the pharmaceutical sector.
Maria is also a published author with 13 technical articles written for Faulker
Information Services.
Maria & John Montana are Project/Program consulting Managers, consulting regulatory
compliance engineers, computer validation specialists, quality assurance managers, technical writers and editors. Full regulatory
compliance services are offered.
Complete Regulatory Compliance Services Offered:
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PROFESSIONAL EXPERIENCE:
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Self motivated,
self starter with the ability to prioritize and multi-task in a fast paced environment
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Extensive management
and project management skills
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Excellent written
and verbal communication skills
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Expertise in
the Pharmaceutical and Medical Device industries
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Veteran in working
under consent decrees
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In depth knowledge
of FDA GxP, Regulations, particularly 210, 211, 820, and 21 CFR Part 11
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Working knowledge
of ISO, SOX, DEA, DOT, EPA, HIPAA Standards, particularly ISO 9000 and 13485
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Computer Validation
- Built Computer Validation functional
unit to implement computerized system regulatory compliance
- Developed remediation action plans
for companies under disciplinary actions
- Established CAPA (Corrective and Preventive
Action) plans to retain a regulatory compliant state
- Investigated, composed, executed,
and summarized validation documentation (including but not limited to plans, protocols, Installation Qualification (IQ), Operational
Qualification (OQ), Performance Qualification (PQ), deviation reports, and other reports) in accordance with governing regulations
- Implemented 21 CFR Part 11 (electronic
records and electronic signatures) compliance initiatives
- Performed Internal Audits and Vendor
Audits
- Performed baseline
inventory, gap analysis, contingency factor assessment, and risk assessment on systems and processes
- FMECA Analysis
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Quality
Assurance
- Established processes ensuring compliance
to governing regulations
- Built quality into systems and processes
by developing, implementing, and maintaining quality initiatives
- Installed and maintained quality assurance
software
- Managed and coordinated software release
activities
- Responsible for determining, reviewing,
managing, and tracking the documentation required for regulated projects
- Developed test cases and test scripts,
logging tests and tracking results, and reporting status
- Managed and executed Change Control
Process
- Managed Change
Control operations in a regulated environment
- Provided Account
Measurements, Matrices, and Status Reports
- Generated, executed,
and summarized unit test plans
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Project Management
- Managed projects with cross-functional
teams at domestic and international facilities
- Performed gap analysis, contingency
factor assessment, risk analysis, and statistical sampling
- Trained and managed
personnel with various skills and knowledge, but not limited to validation experience, in preparing and executing validation
protocols, summary reports, and qualification documents
- Communicated
with the Regulated Service Delivery Teams, Delivery Project Executive and Regulatory Compliance Officer
Technical Writing and Editing Services
- Master Validation Plans, Site Validation Plans, Validation Project Plans
- Qualification Documents, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Statistical Reports
- Standard Operating
Procedures (SOPs) and Work Instructions (WI)
Review and Analysis
- Risk Assessment and Analysis
- Corrective and Preventive Analysis (CAPA)
- Gap Assessment and Analysis
Audits
- Internal Audits
- Vendor Audits
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