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Expertise
Pharmaceutical Consultant, Regulatory
Compliance Consultant, Pharmaceutical Quality
Assurance Expert, Quality Control Consultant, Regulatory Compliance
Consultant, Product Development Consultant, Due Diligence
Audit, Investigation, Expert, Engineering, Consulting,
Services, Validation Study Consultant, Specialist, Investigation, Expert,
Engineering, Consulting, Services, Six Sigma Consultant, LEAN Consultant,
Quality Improvement Consultant, Business Excellence Consultant,
Process Improvement Consultant, Systems Improvement Consultant, Process Troubleshooting, Process Optimization Consultant
Expertise in operational excellence, Six
Sigma, Baldrige business transformation, validation, regulatory compliance, intellectual
property and business due diligence, research and development, technology
transfer, and remediation with an impressive and verifiable list of
accomplishments in pharmaceuticals, medical devices, and other industrial
sectors; Expertise in regulatory compliance audits, remediation plans
development and implementation, templates for and development, execution, data
analysis, and final report development of ES/COMM./IQ/OQ/PQ/PkV protocols for
facilities/utilities, equipment, and computer systems (GxP and 21 CFR Part 11
regulations); Experienced in development and revision of standard operational
procedures (SOPs) and Validation Master Plans; Have leading edge knowledge in
biomaterials, material surface treatment, tribology, colloids, cutting tools,
membranes, powders, gels, fluid pumping and processing, aseptic filling,
lyophilization, sterilization and packaging; Have developed proprietary
models/templates for due diligence of regulatory compliance and operational
excellence comprising systems of quality, facility and equipment, materials,
production, packaging and labeling, laboratory controls as well as intellectual
property, product’s commercialization phases, cost of quality, performance and
productivity, manufacturing plants, and business entities; Have thorough
know-how in process analytical
technology, quality by design, quality function deployment, design
controls, system/component impact assessment, critical process parameters,
critical quality attributes, deviation investigation, CAPAs, quality risk
management, PMA, 510K and IDE, modeling, statistics, Six Sigma and Baldrige
performance, lean manufacturing quality and productivity tools;
Expertise in quality control, quality assurance and regulatory affairs, medical
products businesses, chemistry, manufacturing and controls (CMC) section of drug
master files, DMFs, analytical methods and process plans, protocols and reports,
form FDA 483 and warning letter responses, corrective and preventive action
plans, training, general cGMP, general validation, and test method validation,
negotiations with regulatory agencies, customers, distributors and internal
group, data analysis including specification development and rationalization,
trend analysis, expiration and retest date justification, test method
characterization and validation, site qualification processes, product design
validation documentation, test method validation document evaluation, data
traceability audits, manufacturing process validation master plans, new product
development, planned discontinuance of out-dated products, NDA pre-approval
inspections, corrective actions, responses and re-inspection, chemical
manufacturing processes, good manufacturing practice (cGMP), total quality
management and ISO 9001 registration processes, in vitro diagnostic reagent,
instrument design control and quality control.
Expertise in pharmaceutical quality assurance, quality control, project
management, regulatory affairs, product development, management, 26
years experience in product development, process development,
validation, large scale
manufacturing facility validation and startup, process development,
validation, production management, quality assurance, quality control
of FDA licensed biotechnology, small molecule and device products,
regulatory experience, GMP audit, regulatory compliance, quality
system development, validation, document control, laboratory
management, facility environmental monitoring, internal
compliance and auditing, process validation, microbiologic
and chemical testing of materials and finished product, product
stability, plant EM, product test and release programs, stability
programs, instrument validation, and cleaning validation programs,
statistical process control based production planning, QC laboratory
management, drugs, ointments, creams, tablets, aseptic processing,
powders, dissolution rate, deformulation, remediation, significant
investigations, variances, protocol deviations, preventative actions,
corrective actions
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