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Detailed Technical Consulting and Support:
Compliance Remediation Services Support or Consultancy:
- FDA Warning Letters
- Routine Form 483 Corrective Actions
- Consent Decree Remediation Work
- Cleanroom Contamination Control Practices Consultancy:
- Creating Disinfection Programs
- Validating and Qualifying Disinfectants (Disinfectant Qualification for New and Existing Disinfectants and Sanitizers)
Contamination Control and Sterility Assurance Support or Consultancy:
- Aseptic Practices and Programs
- Cleanroom Personnel Behaviors and Practices Program
- Personnel, Gowning Practices and Program
- Cleanroom Trafficking Processes
- Personnel, Product, Equipment and Waste Flow
Product Release Quality Control (QC)/Microbiology Testing Support or Consultancy:
- Quality Control Testing Programs:
- Bacteriostasis and Fungistasis (B & F) Testing Program
- Bacteria Endotoxin (LAL) Programs and Validation Tests, Biological Indicators Qualification and Testing Programs
- Bioburden Testing
- Conductivity Testing Program
- Growth Promotion Testing Program
- Materials Controls Program
- Microbial Identification Programs (Phenotypic and Genotypic Testing)
- Osmolality Testing Program
- pH Testing Program
- Product Identity Testing
- Product Potency Assays
- Sterility Testing Program
- Tissue Culture Assays
- Various Quality Control Testing Procedures
- Environmental Monitoring Testing Operations
- Environmental Monitoring for New and Existing Facility Validation
- Environmental Monitoring Data Management
- Environmental Monitoring Excursion Investigation Program
- Environmental Monitoring Programs
- Environmental Monitoring Remediation Process
- Environmental Monitoring Trend Reporting
- Establishment of a Quality Management Systems
- Laboratory Information Management System (LIMS) for a Quality Control Laboratory
- Quality Control Data Management
Cleanroom Utility Program (Water Systems) Support or Consultancy:
- Design of a New and Modification of Existing Water Systems:
Clean steam System
Distilled Water System
Reverse Osmosis (RO)
Water for Injection (WFI)
- Validation of Water Systems (Protocols, Testing and Reports)
- Designing Routine Water Testing Programs
- Validation Guidance for all Water Systems
Cleanroom Utility Program (Gas Systems) Support or Consultancy:
Design of a New and Modification of Existing Gas Systems:
- Argon Gas
- Compressed Air
- Nitrogen Gas
- Validation of Gas Systems (Protocols, Testing and Reports)
- Designing Routine Gas Testing Programs
- Validation Guidance for all Gas Systems
Product Stability Program Support or Consultancy:
- Accelerated Aging Design and Testing
- Design of Stability Data Management and Trending
- Design of Stability Program for New and Existing Product
- Design of Stability Protocols and Reports
Raw Material Receipt and Qualification Program Support or Consultancy:
- Design of Raw Material Inventory System
- Raw Materials Receipt and Test Specification Processing
Raw Material Qualification and cGMP Requirement
Regulatory Affairs Support or Consultancy:
Regulatory Affairs Technical Writing and Review of CMC, IND, NDA Sections
Regulatory Affairs New and Existing Product Filing and Support
Sterilization Validation and Routine Testing Support or Consultancy:
Biocompatibility Testing
E-beam Sterilization
Ethylene Oxide Sterilization
Steam and Dry Heat Sterilization
Vaporized Hydrogen Peroxide (VHP) Sterilization
Radiation Sterilization
New Medical Device Sterilization Evaluation and Biocompatibility Evaluation
Cleanroom Facility Design and Validation Support or Consultancy:
Air Exchange Requirements
Creating a Basis of Design
Creating a Cleanroom Design
Creating a Facility Validation Protocol and Reports
Creating a User Requirement Specification
Creating Cleanroom Parameters
Creating EM Sample Sites, Selection and Specifications for Facility Validation
Design and Validation of Cleanrooms
Differential Pressure Requirements
Humidity Requirements
HVAC Requirements
Temperature Requirements
Troubleshooting Facility/Cleanroom Issues
Quality Investigations Support or Consultancy:
Corrective Action and Preventative Action (CAPA) Reporting System
Departure from QC Procedures
Environmental Excursion Investigation and Program
Invalid Assay Reporting System
Laboratory Investigation Reporting System
Out of Specification Investigation
Sterility Test Failure Investigations and Programs
Deviation Investigations
Investigations, Tracking and Trending
Product Complaint Investigation
Product Non-conformance Investigations
Quality Control and Quality Assurance Auditing Support or Consultancy:
Performs External Auditing
Performs Internal Audits
Performs Vendor Audits and Supplier Qualification
Prepares a QC Lab for all Regulatory Body Audits
Technical Writing of Procedures, Methods, Protocols and Reports Support or Consultancy:
Technical Writing of all Quality Control (QC) Standard Operating Procedures (SOP)
Technical Writing of all Quality Assurance (QA) Procedures
Technical Writing of all Quality Control (QC) Standard Test Methods (STM’s)
Updating all QC and QA Procedures to meet different Regulatory Body’s
Compliance RequirementTechnical Writing of Validation Protocols and Reports
Technical Writing of all Quality Investigations
- Corrective and Preventative Action (CAPA) Investigations
- Out of Specification (OOS) Investigation
- Invalid Assays Investigation
- Deviation Investigation
- Environmental Monitoring Investigations
Quality Control Lab Designing and Start-Up Support or Consultancy:
Designs and Plans all Quality Control Laboratories
Performs a Full Quality Control Lab Restructuring and Reorganization
Performs a Full Quality Control Lab Setup
Validation Programs Support or Consultancy:
Cleaning Validation
Design and Validation of a Barrier Isolator System
Facility Validation
Method Validation
Process Validation
Validation of MicroSeq Microbial Identification System
Validation of a New Vitek 2 Compact System
Validation of all QC Equipment
Validation of a VHP Sterilization Unit
Sterilization Validation (Ethylene Oxide, Radiation, Steam, Vaporized Hydrogen Peroxide, E-beam)
Subject Matter Expert for the Following Regulatory Bodies:
FDA Requirements and Regulations.
BSi Requirements and Regulations.
CFR Requirements and Regulations.
EMEA Requirements and Regulations.
EU Requirements and Regulations.
ICH Requirements and Regulations.
ISO Requirements and Regulations.
JP Requirements and Regulations.
MCA Requirements and Regulations.
TGA Requirements and Regulations.
CFIA Requirements and Regulations.
Equipment Purchase and Set-Up Support or Consultancy:
Abbott Quantum IITM Analyzer
ELISA
PCR
GC
HPLC
Kinetic LAL Testing- ELX 808 Plate Reader
MicroSeq DNA Sequencing Equipment
MilliflexTM
Sterilizers
Steritest
ThinPrepTM 2000 System
Vitek Compact II
Compliance Programs Support or Consultancy:
Consultancy Support for Companies with FDA’s Form 483 Findings
Consultancy Support for Companies with FDA’s Warning Letter
Consultancy Support for Companies Undergoing FDA Consent
Decree Remediation
Quality Assurance Documentation Support or Consultancy:
Product Batch Record Review
Quality Assurance Product Release
Quality on the Floor Support (Quality Engineering)
Document Control and Product Test Data Review and Support