Process
Analytical Technology (PAT)
Product
Development
Process Development and Validation
Technology Transfer
Computer Systems Validation
Laboratory and Analytical Support
Quality Assurance
Regulatory Affairs
Manufacturing and Manufacturing Support
Training and Training Program Design
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| Process
Analytical Technology (PAT) |
More Details
Develop a PAT Vision and Strategy
Define Critical Process Parameters
Identify and Deploy Analytical Technology
Create a Data Management Infrastructure
Ensure Organizational Sustainability
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| Product
Development |
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Formulation Development
Excipient/Ingredient Selection
Analytical Methods Development
Analytical Testing and Support
Product Development Report Writing
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| Process
Development and Validation |
Manufacturing Process Development and Validation
Process Assessment and Optimization (Design of Experiments/SPC)
Equipment Qualification
Cleaning Validation
SOP
Development
Manufacturing Scale-Up
Technology Transfer
Technical Report Writing (Validation, etc.)
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| Technology
Transfer |
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More
Details
Total Technology Management (TTM)
Technology Transfer Program Design and Implementation
Knowledge Management -- Technology Transfer File (TTF)
Process Assessment and Optimization
Policies/Procedures (SOP) Development
Equipment Qualification and Validation (IQ,OQ,PQ)
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| Computer
Systems Validation |
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Assessment and Remediation of Manufacturing, Laboratory,
Medical Device, R&D Facilities and Equipment
21 CFR Part 11 Compliance
Validation Master Planning
Computer-Controlled (PLC, PC, DCS) Process and Laboratory
Equipment
Database Management Systems (LIMS, ERP, MRP, MES, EMS,
Doc. Management)
Software Supplier Audits
Polices, Guidelines and SOPs
IQ, OQ, PQ Protocols
Validation Training
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| Laboratory
and Analytical Support |
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Analytical Method Development and Validation
Cleaning Validation and Analytical Testing (Verification)
Equipment Qualification (IQ,OQ,PQ)
Stability Program Design
SOP Development
Lab Throughput and Workflow Assessment/Optimization
cGMP and Technical Training
Analytical Testing
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| Quality Assurance |
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cGMP/Quality Systems Auditing
Quality Systems Design, Management, Remediation
Stability Program Design/Implementation
Policies and Procedures (SOP) Development
Training and Training Documentation
Process Drift Audits
Vendor Audits
Remediation/Intervention
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| Regulatory Affairs |
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More Details
Regulatory Evaluation and Strategy
Regulatory Submissions Preparation
FDA Communications
Team Leadership
Clinical Shipment Distribution
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| Manufacturing
and Manufacturing Support |
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Cleaning Methods Development and Support (Cleaning Validation)
Vendor Certification Process Design and Implementation
Process Cycle Time Reduction
Critical Path Management
Barrier/Isolation Systems Design
Sterilization Cycle Development
Water Systems Validation
Aseptic Manufacturing Systems Design
Filling and Packaging Process Design and Validation
Documentation Systems Assessment and Remediation
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| Training
and Training Program Design |
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Training Program Assessment
Training Program Design, Delivery and Implementation (Standardized,
Competency-Based)
Development of Training Program Infrastructure (Metrics,
Curricula and Lesson Plans)
Training of Trainers
Design of Computer-Based and Web-Accessible Training
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